Conditions: Separation Anxiety Disorder
Keywords: Adult separation anxiety disorder ASAD
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 24
Healthy volunteers: no

Brief summary:
The purpose of this study is to determine whether Vilazodone (Viibryd), an SSRI and 5HT1a receptor agonist, is effective in treating Adult Separation Anxiety Disorder over a 12-week treatment course.

Detailed description:
In this randomized clinical trial, 40 adults with a principal diagnosis of Adult Separation Anxiety Disorder (ASAD) and no major depression or substance abuse disorders will be randomized to 12 weeks of treatment with vilazodone (flexibly dosed) or matched pill placebo. Outcome will be assessed in respect to symptomatic improvement, quality of life, adverse events and safety.

Arms:
arm 1: Vilazodone treatment. Dosage will begin at 10mg/day and will be increased to 20mg/day after 1 week, and 40mg/day after two weeks (optional). Dosage can be held steady or lowered at any time during the study as clinically indicated in the event of adverse effects. Twelve weeks of treatment, total. arm 2: Pill placebo.

Interventions: intervention 1: Vilazodone intervention 2: Placebo
Intervention descriptions: intervention 1: 10mg to 40mg per day for 12 weeks intervention 2: One to two pills per day for 12 weeks

Protocol document:
ICF_001.pdf: 
09/30/2016  
 
6856 
  
 
IRB # 6856                                                                     
Sponsor: Forest Laboratories   
Principal Investigator: Franklin Schneier, M.D  
  
CONSENT FORM – Cover Sheet  
Vilazodone for Separation Anxiety Disorder in Adults  Overview of Study  
  
Purpose: To compare the effectiveness of the antidepressant medicine vilazodone, versus  
placebo, in the treatment of Separation Anxiety Disorder in adults. There have been no 
published studies of the treatment of Separation Anxiety Disorder in adults.  
  
Procedures:   
• 
Eight visits to the Anxiety Disorders Clinic over a 12-week period  Research 
treatment for 12 weeks:  
o Half of participants will be assigned to take vilazodone (Viibryd), a treatment 
that is FDA-approved for depression, but has not been previously studied for 
separation anxiety disorder.  
o Half of participants will be assigned to take a placebo (inactive pill).  
o Assignment to vilazodone or placebo will be done at random (flip of a coin), 
and you will not find out which you are getting until you end study 
participation.  
o You will be asked to not start psychotherapy during the time of your 
participation in this study.  
Risks:   
• 
Study medication may not help.   
• 
Side effects may occur.  
• 
Pregnant women should not participate in this study.  
  
Compensation: Up to $300 total for completing all study visits.  
  
Confidentiality: All records will be confidential to the extent permitted by law.  
  


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Your Rights: Your participation is voluntary, and you may withdraw from the study at any  
time and seek alternative treatment if you wish.  
  
CONSENT FORM  
Vilazodone for Separation Anxiety Disorder in Adults  
  
Contact for questions and emergencies   
Dr. Franklin Schneier or your study doctor is available to answer your questions at any 
time. They can be reached during the day at (646) 774-7000. After 5 PM you can page 
the  
Anxiety Clinic Doctor on Call at (917) 996-6939. Dr. Schneier can be reached by mail at 
Unit 69, 1051 Riverside Drive, New York, NY 10032.  
  
PURPOSE OF STUDY  
You are being asked to participate in this research study because you are an adult with 
Separation Anxiety Disorder. This study compares the effectiveness of vilazodone (brand 
name Viibryd) to placebo in the treatment of 40 persons with Separation Anxiety Disorder. 
The placebo looks like the other pill, but does not contain any medicine (it is sometimes 
called a “sugar pill”). There are no published studies of treatments for adults with  
Separation Anxiety Disorder and no medications approved for this condition. Vilazodone 
is a medication that is FDA-approved for the treatment of depression but has not been 
studied for Separation Anxiety Disorder. This study is sponsored by Forest Laboratories, 
the manufacturer of vilazodone.  
  
ALTERNATIVE TREATMENTS  
You do not have to participate in this study to receive treatment for Separation Anxiety 
Disorder. Vilazodone is available by prescription and can be prescribed by your regular 
medical doctor. Other treatments for Separation Anxiety Disorder include psychotherapy 
such as cognitive behavioral therapy, and off-label use of antidepressants, such as 


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paroxetine (brand name Paxil) or sertraline (brand name Zoloft). Your doctor will discuss 
benefits, risks and side effects of study participation with you. The alternative to 
participating in this study would be to get treatment elsewhere without the research 
interviews and procedures, and without the possibility of getting a placebo.       
  
STUDY PROCEDURES  
This study involves your taking study pills daily, and visiting the Anxiety Disorders Clinic up 
to 8 times (total of 4-1/2 hours) over 12 weeks. You will be assigned at random (flip of a 
coin, with a 50/50 chance for each) to take either vilazodone or placebo. Neither you nor 
the researchers will know if you are getting the placebo (inactive pill), but they can find out 
in an emergency.    
You have already met with your study doctor to discuss your medical and 
psychiatric condition. In addition, you were asked standard questions and received a 
medical exam, including blood and urine tests, a urine drug screen and an 
electrocardiogram (EKG).  
You will need to be off all psychiatric medication for at least two weeks before 
starting study treatment, except for the sleep medication zolpidem (brand name Ambien 
or Ambin CR). If you have been taking zolpidem consistently over the four weeks prior to 
study treatment, you will be allowed to continue using it during the study. During the study 
you should not take any medication nor receive any psychotherapy without approval of 
your study doctor.   
If you are taking a medication that has been helpful but is not allowed in the study, 
you cannot participate in the study. If you are on medication that has not been helpful and 
is not allowed in the study, your study doctor will ask your permission to contact your 
treating doctor. If you agree, the medication will be stopped in consultation with your 
treating doctor. You will be monitored with weekly visits during this period. If you are on 
medication that has not been helpful and you do not want your treating doctor to be 
contacted, you will not be able to participate in this study.   


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To participate in this study, you must agree to avoid using alcoholic beverages or 
recreational drugs during the study, because they might cause problems if combined with 
your medication. You must also agree to avoid starting psychotherapy during the study, 
because it could interfere with evaluating the study medications.  
  
Study Treatment  
You will see your study doctor for about 30 minutes weekly for two weeks, and then every 
other week for six weeks, and then four weeks later. At each visit your study doctor will 
ask about any improvements or side effects that you have noticed. The doctor will adjust 
the dose of the medicine to try to maximize your improvement. The doctor will give you 
study medication (vilazodone or placebo), which you should take as instructed. The 
medication should not be taken by anyone else, and it should be kept in a safe place out 
of the reach of children.   
You will also be asked about your symptoms by a study rater at each visit. You will 
also be asked to complete questionnaires at each visit. At three of the study visits, you will 
also be asked to sit at a computer monitor for about 10 minutes and view pictures of faces 
and then a pointer (“<” or “>”). You will be asked to press a left or right button, depending 
on the direction of the pointer.   
After 12 weeks of treatment, you will complete the same medical exam you 
received at the beginning of treatment (physical exam, blood tests [equivalent of two 
tablespoons], urine tests, EKG). If you are discontinuing study medication you will be 
given instructions on how to reduce it gradually.  
  
The doctor in charge of the study can remove you from the study without your 
consent for one of the following reasons:  
• 
If in his judgment, you need an alternative treatment.  
• 
If you fail to follow the study rules.   
• 
If your condition significantly worsens during the study.  
  


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Treatment After You End Study Treatment   
At the time you end study treatment you will be offered further treatment in the clinic with 
vilazodone or with another medication if recommended by your clinic doctor, for three 
months. All visits with your doctor will be free of charge for three months. Medication will 
be free of charge for the first month, and after that you may have to pay for your 
medication. After three months you will be referred for follow-up care if needed. If at any 
time after you end study treatment you would like treatment other than medication you 
can be referred to such treatment. You can get such treatment while you are receiving the 
three months of after-study medication treatment offered in the clinic.   
     When you leave the study, an Anxiety Disorders Clinic doctor will meet with you, 
inform you whether you were taking vilazodone or placebo during the study, and answer 
any questions you may have about this.  
  
RISKS  
Study Treatments: The main risk of this study is that the research treatments may not 
help your symptoms. Even if you receive vilazodone, it may not help your Separation 
Anxiety Disorder, and your symptoms may get worse. A common treatment for Separation 
Anxiety Disorder includes psychotherapy such as cognitive-behavioral therapy, but it may 
be up to 17 weeks from the time you enter the study until you would be provided with 
psychotherapy or another type of treatment, such as other medications. Additionally, 
because you will not find out whether you have been taking vilazodone or placebo until 
you leave the study (except in the event of an emergency), decisions about your 
treatment during the study will not be able to take that information into account.  
Other possible risks to you are the side effects that some people get from 
vilazodone. You should not drive or operate complex or heavy machinery if study 
medication is affecting your thinking or reflexes. Side effects that may occur include 
sweating, rash, nausea, vomiting, increased or decreased appetite, weight loss or gain, 
sleepiness, fatigue, insomnia, dizziness, nervousness, cough, running nose, dry mouth, 
muscular tremors, changes in heart rate, elevated mood, and sexual problems, including 


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loss of interest for both sexes, difficulty having orgasm in women, and difficulty having an 
erection or ejaculating in men. Vilazodone may cause unexpected problems if combined 
with other medications you might take during the study.    
Stopping vilazodone too rapidly may cause dizziness, agitation or anxiety, nausea 
and sweating. These symptoms usually resolve over time. You should not stop study 
medication before discussing it with your study doctor.  
While vilazodone is considered to be a safe treatment, the Food and Drug  
Administration (FDA) has issued a public health advisory about a possible link, in rare 
cases, between suicidal thoughts or behavior in patients treated with antidepressant 
medications (including vilazodone). The FDA has asked health care providers and 
patients to note that worsening of depression could be related to the underlying disease 
process, or in some cases, might be a direct result of antidepressant drug treatment.  At 
the present time, the FDA has not concluded that these drugs cause worsening 
depressive symptoms or suicidal ideation or behavior, and this is an area of active 
research. The FDA advisory urges careful monitoring of patients receiving these 
medications during the beginning stage of therapy and during increases or decreases in 
dosage.  
To minimize risks of study treatment, you have been checked for conditions that 
can increase risks of treatment, and you will be closely monitored for side effects at every 
visit. A study doctor will be available by pager 24 hours/day. Your study doctor can adjust 
the doses of study medications to minimize side effects. If you need to take any other 
medications during the study, you should first contact your study doctor to minimize the 
risk of drug interactions. You may leave the study at any time. In the event of a medical 
emergency, your doctor will be able to find out what medication you have been taking 
during the study.  
  
For women:  You should not be in this study if you are pregnant.  Women who take 
vilazodone during pregnancy or who become pregnant while taking it may be at greater 
risk of having a baby born with a birth defect. You must agree to use birth control 


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throughout the course of your treatment with medication. If you decide to stop using birth 
control, or if there is a possibility that you are pregnant during the study, you must tell your 
study doctor immediately so that a pregnancy test can be done, and we can decide 
whether you should continue in the study.  
  
Blood Drawing may cause mild discomfort and, rarely, a small arm bruise, clot or infection 
may occur at the site.  
Ratings: You may feel mild to moderate upset or frustration due to answering questions 
about your life or filling out questionnaires. Study staff are skilled at dealing with these 
events and will try to help you feel as comfortable as possible (e.g., by giving breaks 
during an evaluation, offering encouragement).  
  
  
BENEFITS:  
A direct benefit to you is the possibility that the research treatment may help your 
Separation Anxiety Disorder symptoms.  In addition, your participation may help 
researchers learn more about how to treat Separation Anxiety Disorder. There may be no 
benefit to you if the treatment is not effective.    
  
COMPENSATION:  
You will receive $60 for each of the first and last visits, and $30 for each of the 6 interim 
visits you complete, to be paid in cash after the completion of each visit (up to $300 total), 
as payment for your time. You will be paid for each of these visits that you complete on 
schedule, whether or not you are continuing on study treatment.  
  
CONFIDENTIALITY:   
All records related to the study are confidential, although state and federal agency, and 
Forest Laboratories personnel may inspect records. Similarly, there are legal advocacy 
organizations that have the authority under the law to access otherwise confidential 


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subject records. They cannot re-disclose this information without the subject’s consent. All 
records will be confidential to the extent permitted by law. Your records will be kept in 
locked files and access will be allowed only to members of the research team, or 
institutional personnel as part of a routine audit. Should any of the information gathered 
from you be used for scientific publications or presentations, you will be protected through 
the use of a system of codes that will not reveal the identity of individuals. Any report 
based on this study will only be used as grouped information without mention or 
description of the individual participants.   
         Your name and other personal identifying information will be stored in an 
electronically secure database at New York State Psychiatric Institute. Research data that 
is entered into the computer will be stored according to study ID number. A master list 
linking the patient name to the assigned ID number is kept in a separate file. To access 
the computer and appropriate data files, the staff member must have knowledge of the 
password and be given rights to access the data by the data manager. All data that is 
transmitted via computer is encoded and identifying information is removed.  
        A description of this clinical trial will be available on http://www.ClinicalTrials.gov , as 
required by U.S. Law. This Web site will not include information that can identify you. At 
most, the Web site will include a summary of the results. You can search this Web site at 
any time.  
  
RESEARCH STANDARDS AND PARTICIPANTS’ RIGHTS:  
Participation in this research study is voluntary. If you decide not to participate, or if you 
later decide to stop participating, you will not lose any benefits to which you are otherwise 
entitled. A decision not to participate will not effect your treatment at the New York 
Psychiatric Institute. The doctors participating in this research study are also responsible 
for your clinical care in the Anxiety Disorders Clinic, even after you end the study. You will 
be notified of significant new findings that may relate to your willingness to continue to 
participate in the study.  
  


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Medical Compensation for Research-Related Injuries  
Federal regulations require that you be informed about the institution's policy with regard 
to compensation and payment for treatment of research-related injuries. Short term 
emergency medical treatment, which has been determined to be necessary by New York  
State Psychiatric Institute's doctors, and which is within the capability of New York State 
Psychiatric Institute will be provided.  In addition, you will be provided assistance in 
arranging follow up care in such instances.  
  
New York State Psychiatric Institute and Research Foundation for Mental Hygiene 
do not provide compensation or payment for treatment of research related injuries. 
However, you should be aware that participation in this research does not waive any of 
your legal rights to seek such compensation through the courts.  
  
Dr. Schneier or your study doctor is available to answer your questions about the 
study at any time.  They can be reached during the day at (646) 774-7000.  After 5 PM 
you can page the Anxiety Clinic Doctor on Call at (917) 996-6939.  In addition, an 
emergency psychiatric consultation is always available to you by calling these numbers.  
The doctors participating in this research study are also responsible for your clinical care.    
 If you have any questions about your rights as a research participant or any complaints, 
you may call the NYSPI-IRB Main Office at (646) 774-7155 during regular office hours.  
  
You will be given a copy of the signed Consent Form to keep.   
  
 
 
 
 


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STATEMENT OF CONSENT  
I voluntarily agree to participate in the research study described above.    
  
NAME                                                      (print)  
  
Date________________ Signature ________________________________                                          
  
  
  
   
  
  
  
Study Participant  
I have discussed the proposed research with the patient, and in my opinion, this patient 
understands the benefits, risks and alternatives (including non-participation) and is 
capable of freely consenting to participate in this research.  
  
NAME                                                      (print)  
  
Date                               Signature________________________________                                             
                        
  
  
  
  
Study Physician  
  

Prot_002.pdf: 
New York State Psychiatric Institute 
Institutional Review Board 
 
October 07, 2016 
 
 
To: 
 
Dr. Franklin Schneier 
From:  
Dr. Edward Nunes, Co-Chairman 
 
 
Dr. Laurence Greenhill, Co-Chairman 
 
 
 
 
 
Subject: 
Approval Notice: CONTINUATION  
 
 
  
 
 
 
 
Your protocol # 6856 entitled: VILAZODONE FOR SEPARATION ANXIETY DISORDER IN ADULTS 
Protocol version date 10/07/2016 and consent forms have been approved by the New York State 
Psychiatric Institute - Columbia University Department of Psychiatry Institutional Review Board 
from October 21, 2016 to October 20, 2017. (Reviewed at the Full Board meeting on September 
26, 2016.) 
 
Consent requirements: 
      Not applicable:  
    45CFR46.116 (d) waiver or alteration of consent for the telephone interview   
     ¥ Signature by the person(s) obtaining consent is required to document the consent process 
      Documentation of an independent assessment of the participant’s capacity to consent is also 
required. 
Approved for recruitment of subjects who lack capacity to consent: ¥ No  Yes    
 
 
Field Monitoring Requirements: ¥ Routine Special: ___________________  
 
 
3  Only copies of consent documents that are currently approved by the IRB may be used to obtain 
consent for participation in this study. 
3  A progress report and application for continuing review is required 2 months prior to the 
expiration date of IRB approval. 
3  Changes to this research may not be initiated without the review and approval of the IRB except 
when necessary to eliminate immediate hazards to participants.  
3  All serious and/or unanticipated problems or events involving risks to subjects or others must be 
reported immediately to the IRB.  Please refer to the PI-IRB website at http://irb.nyspi.org for 
Adverse Event Reporting Procedures and additional reporting requirements.    
 
Cc: 
RFMH Business Office (Forest Labs) 
 
Encl:  CF, recruitment materials, HIPAA 
 
EN/LG/alw 
Signed copy on file at IRB 
 
             v. 11/15/13 


Protocol Summary Form
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Schneier, Franklin
Page 1 of 18
Protocol Title:
Vilazodone for Separation Anxiety 
Disorder in Adults
Protocol Number:
6856
First Approval:
11/12/2013
Expiration Date:
10/20/2016
Version Date:
10/07/2016
Clinic:
Anxiety Disorders Clinic
Contact Principal Investigator:
Franklin Schneier, MD
Email: frs1@columbia.edu
Telephone: 646-774-8041
Co-Investigator(s):
Raphael Campeas, MD
Research Chief:
B. Timothy Walsh, MD
Cover Sheet
Choose from the following that is applicable to your study
I am submitting an annual continuation without modifications 
Division & Personnel
Division
What Division/Department does the PI belong to?
Clinical Therapeutics
Within the division/department, what Center or group are you affiliated with, if any? 
Anxiety Disorders Clinic
Unaffiliated Personnel
List investigators, if any, who will be participating in this protocol but are not affiliated with New York 
State Psychiatric Institute or Columbia University. Provide: Full Name, Degrees and Affiliation.
None


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Schneier, Franklin
Page 2 of 18
Application for Continuation of Research
Status
Current Status of Study: 
Subject enrollment is ongoing.
Summary of Experiences to Date
Please provide a summary of scientific progress of the study and the experience of research participants, to 
date. This requirement is designed to allow for the investigator and the IRB to reassess the study’s risks and 
benefits in terms of developments in the field, changing practice patterns, and new IRB policies and 
procedures.
To date, we have enrolled 18 subjects with Adult Separation Anxiety Disorder (13 females, 5 males). Study 
procedures have been generally well tolerated. One serious adverse event occurred and has been reported to 
the IRB, involving a patient reported to have been admitted to a hospital with the flu (and subsequently 
found to have been on placebo). 
 
There have not been any study findings, recent literature, or untoward events occurring here or at other sites 
in the past year which might affect the analysis of the safety, risks or benefits of study participation.  
 
Funding
Have there been any changes in funding status since the prior approval? 
No
Have the principal investigator and other investigators made all required disclosures of financial interest in 
the study sponsor/product?
Yes
Summary
Have there been any study findings, recent literature, or untoward events occuring here or at other sites in 
the past year which might affect the analysis of the safety, risks or benefits of study participation? 
No
Have there been any serious adverse events (serious and/or unanticipated problems involving risks to 
subjects or others at this site which occured in the past year)? 
No
Have all study staff with a significant role in the design or implementation of the human subject components 
of this study received required training in human research subject protections?
Yes
Is the study covered by a certificate of confidentiality? 


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Schneier, Franklin
Page 3 of 18
No
Overall Progress
Approved sample size
50
Total number of participants enrolled to date
18
Number of participants who have completed the study to date 
12
Have there been any significant deviations from the anticipated study recruitment, retention or completion 
estimates? 
Yes
Describe actions taken or planned to address these problems. 
Recruitment was initially much slower than anticipated. We expanded recruitment approaches and have had 
a much greater flow of participants (n=13) in the past year. 
Comments / additional information 
None
Sample Demographics
Specify population
Adults with separation anxiety disorder
Total number of participants enrolled from this population to date 
18
Gender, Racial and Ethnic Breakdown 
Female patients: N = 13
Male patients: N = 5
 
Race:
Other: N = 3
Asian: N = 2
African American: N = 5
Caucasian: N = 8
Summary of Current Year's Enrollment and Drop-out 
Number of participants who signed consent in the past year
13
Number of participants currently enrolled
4
Did the investigator withdraw participants from the study? 
Yes






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Page 6 of 18
greater than mild severity, and no substance abuse disorders will be randomized to 12 weeks of treatment 
with vilazodone (flexibly dosed) or matched pill placebo. Outcome will be assessed in respect to 
symptomatic improvement, quality of life, adverse events and safety.
Background, Significance and Rationale
Background, Significance and Rationale
Separation Anxiety Disorder is a prevalent condition that has been newly placed in the Anxiety Disorders 
section of DSM5. Though separation anxiety was previously assumed to be confined to childhood, the 
National Comorbidity Survey Replication revealed a 6.6% lifetime and 1.9% 12 month prevalence of adult 
separation anxiety disorder (ASAD) in the community (NCS-R, Shear et al. 2006). Symptoms of ASAD 
include excessive distress when facing or anticipating separation from home or from attachment figures, as 
well as persistent worries about permanently losing or being abandoned by attachments, or of potential harm 
that may befall them during separations. Individuals with ASAD may be afraid to be alone or without an 
attachment figure close at hand, and may avoid leaving home, sleeping in bed alone, or sleeping away from 
home because of separation fears. There are no established medication or psychotherapy treatments for 
ASAD. Vilazodone (Viibryd) appears to have an ideal pharmacological profile for efficacy for ASAD. In 
well-developed animal models of separation distress, 5HT1a agonists and serotonin reuptake inhibitors 
(SSRIs) have shown efficacy (Winslow and Insel 1991; Simpson et al. 2007). In children, large RCTs have 
reported SSRI efficacy for mixed anxiety disorders which are highly comorbid in childhood, including 
separation anxiety disorder, social anxiety disorder, and generalized anxiety disorder (Walkup et al. 2001, 
2008). 
In this randomized clinical trial, 40 adults with a principal diagnosis of ASAD and no major depression or 
substance abuse disorders will be randomized to 12 weeks of treatment with vilazodone (flexibly dosed) or 
matched pill placebo. Outcome will be assessed in respect to symptomatic improvement, quality of life, 
adverse events and safety.
Specific Aims and Hypotheses
Specific Aims and Hypotheses
Aim 1. To assess the efficacy of vilazodone in the treatment of adult separation anxiety disorder (ASAD).
Primary Hypothesis (1): ASAD patients randomized to 12 weeks of vilazodone treatment will evidence 
greater symptomatic improvement than those randomized to placebo. 
Hypothesis 2: ASAD patients randomized to 12 weeks of vilazodone treatment will evidence greater 
improvement in quality of life than those randomized to placebo.
Aim 2. To assess the safety and acceptability of vilazodone in the treatment of ASAD. Data will be 
collected on adverse events and duration of treatment.
Description of Subject Population


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Page 7 of 18
Sample #1
Specify subject population
adults with separation anxiety disorder
Number of completers required to accomplish study aims
40 randomized
Projected number of subjects who will be enrolled to obtain required number of completers
50
Age range of subject population
18-60
Gender, Racial and Ethnic Breakdown
 We anticipate randomizing 30 women and 10 men; 20 Hispanics and 20 non-Hispanics; 27 whites, 10 
African-Americans, and 3 Asians.
Description of subject population
Men and women, of any race and ethnicity, who present for treatment of DSM5 ASAD at the Anxiety 
Disorders Clinic of the New York State Psychiatric Institute.
Recruitment Procedures
Describe settings where recruitment will occur
Anxiety Disorders Clinic
How and by whom will subjects be approached and/or recruited? 
Subjects who respond to treatment notices will be screened on the phone by a research assistant. After 
psychiatric assessment, the assessing psychiatrist will invite eligible subjects to participate in the study.
How will the study be advertised/publicized? 
Patients will be obtained through: (a) word-of-mouth referrals from former patients, (b) referral from area 
medical and mental health professionals, (c) publicity about the study, including articles in local newspapers 
and magazines, appearances on local radio and television shows, etc., leading to self-referral of prospective 
patients, (d) recruitment notices placed in local media and on the internet (i.e. Facebook and Twitter), (e) 
Columbia Recruit Me, (f) Radio audio ads
Do you have ads/recruitment material requiring review at this time? 
Yes
Does this study involve a clinical trial?
Yes
Please provide the NCT Registration Number
NCT01999920
Concurrent Research Studies
Will subjects in this study participate in or be recruited from other studies? 
Yes


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Describe concurrent research involvement
From the Anxiety Disorders Clinic psychiatric screening evaluation protocol (IRB #5029)
Inclusion/Exclusion Criteria
Name the subject group/sub sample
Adult Separation Anxiety Disorder patients
Create or insert table to describe the inclusion criteria and methods to ascertain them
Inclusion criteria:                                                                                      Method of Ascertainment
1. Males or females between the ages of 18 and 60     History 
 
2. Current primary (most clinically significant)               SCID-I, Clinical
diagnosis of DSM5 ASAD                                              Interview for ASAD
 
3. Able to give consent, fluent in English.                      Clinical Interview 
Create or insert table to describe the exclusion criteria and methods to ascertain them
1. Past or current DSM-IV diagnosis of any psychotic   SCID-I, Hamilton 
disorder; organic mental disorder or other cognitive      Depression Scale
disorder; bipolar disorder; or antisocial personality        17-item total >18
disorder. Current MDD of moderate or greater 
severity. Any other current primary Axis I disorder.
 
2. Recent history (past 3 months) of substance or      SCID-I, urine toxicology
alcohol abuse or dependence (other than nicotine or 
caffeine). 
 
3. Suicidal ideation or behavior (in the past year)       Psychiatric interview, 
that poses a significant danger to the subject.            Score >2 on suicidal                                                          
                              ideation item of
                                                                                    Hamilton Depression                                                       
                              Scale
4. Medical illness that could significantly increase      Medical chart review,
risk of vilazodone treatment or interfere with               physical exam,
assessment of diagnosis or treatment response,        blood and urine tests
including including organic brain impairment from       Consultation with
stroke,CNS tumor, or demyelinating disease; renal,    primary care doctor
thyroid, hematologic or hepatic impairment;                when indicated.
diabetes mellitus.                                                     
 
5. Current or past history of seizure disorder (except    Medical history,
febrile seizure in childhood                                            psychiatric


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                                                                                       interview
 
6. History of non-response to ≥ 2 serotonergic             Medical history
reuptake inhibitor antidepressants (SSRIs and/or 
SNRIs) for the treatment of ASAD after adequate 
treatment trials (adequate treatment is defined as 
at least 8 weeks at an adequate dose[s] based on 
approved package insert recommendations).
 
7. Currently taking medication which has been          Psychiatric Interview
effective for patient’s ASAD.     
 
8. For patients taking any ineffective psychoactive   Psychiatric Interview 
drug or herbal remedy, inability to tolerate or 
unwillingness to accept a drug-free period prior to 
beginning the study of 2 weeks or 5 half-lives 
(whichever is longer) before beginning study 
treatment, or ever having been treated with a depot 
antipsychotic. Fluoxetine washout period
will be at least 5 weeks. 
 
9. Requiring concomitant treatment with any             Psychiatric interview
prohibited medications, supplements, or herbal 
remedies, except for zolpidem, or zolpidem 
extended release for insomnia, which may be 
continued provided the medication has been used 
in a consistent manner for 4 weeks prior to randomization.
 
10. History of intolerance or hypersensitivity to         Psychiatric Interview 
vilazodone, SNRIs or SSRIs.      
 
11. History of light therapy, electroconvulsive            Psychiatric Interview
therapy, vagus nerve stimulation, transcranial 
magnetic stimulation, or any other experimental 
procedure for central nervous system disorders 
within 6 months of beginning this study.
 
12. Pregnancy, lactation; for women of childbearing       History,
potential, not using an effective birth control method      Physcial exam,
(e.g. oral contraceptive or double barrier method)          blood pregnancy
for the duration of the study.                                             test
 
13. Current formal psychotherapy initiated within 3          History
months of beginning this study. This includes: 
psychodynamic, cognitive-behavioral and interpersonal 


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Page 10 of 18
therapies.
Waiver of Consent/Authorization
Indicate if you are requesting any of the following consent waivers
Waiver of consent for use of records that include protected health information (a HIPAA waiver of 
Authorization) 
No
Waiver or alteration of consent
No
Waiver of documentation of consent 
No
Waiver of parental consent 
No
Consent Procedures
Is eligibility screening for this study conducted under a different IRB protocol?
Yes
Indicate NYSPI IRB # 
5029
Describe Study Consent Procedures
The study psychiatrist will determine eligibility and fully explain study procedures. Patients interested in 
participating in research, who understand the risks and benefits of participation, will provide informed 
written consent to participate. 
Patients currently taking psychotropic medication will be carefully evaluated for history of response. 
Patients with inadequate response (persistent diagnosis of ASAD and meeting other inclusion/exclusion 
criteria) to current medication will be evaluated to ascertain that they are receiving the appropriate dose of 
that medication. They will be asked for consent to contact their prescribing doctor. After consultation with 
the pre-study prescribing doctor (if patient consented to contact), patients will be brought up to the maximal 
appropriate dose before determining their eligibility for this study. For patients who remain inadequately 
responsive after an adequate trial of their current medication, after the patient consents to participate in this 
study, the patient will be instructed on how to taper medication as clinically indicated to minimize 
discontinuation-related adverse effects. A study psychiatrist will see the patient weekly during this period 
and complete a CGI-change scale -- a score of 6, much worse, or greater will trigger additional 
clinical assessment and prompt a discussion about continued participation. Such subjects will 
discontinue prohibited medication for > 2 weeks, or 5 half-lives (whichever is longer), (and 5 weeks for 
fluoxetine), before proceeding with the pretreatment assessment. Patients with inadequate response to 
vilazodone will be excluded. Patients will not be withdrawn from effective treatment for the purpose of 
entering this study.
Indicate which of the following are employed as a part of screening or main study consent procedures




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Page 12 of 18
30mg           -->20mg for 4 days, 10 mg for 7 days, then discontinue
20mg           -->10 mg for 7 days, then discontinue.
10mg           --> discontinue
Subjects will also complete a computer-based Attention Bias Measurement at baseline, week 1, and week 12 
visits, using procedures developed by Bar Haim (2010). This will assess bias to look toward angry or neutral 
faces, as a predictor and correlate of treatment response.
The stimuli are face photographs of 20 different individuals, with an angry and a neutral expression for each 
individual. The protocol consists of 120 trials (80 angry-neutral and 40 neutral-neutral presentations). Each 
trial begins with a fixation cross “+” presented in the center of the monitor for 500 ms. Immediately 
following termination of the fixation cue, the computer presents two faces of the same individual, positioned 
vertically. Each pair of faces displays one of two combinations of emotions (i.e., neutral and angry, or 
neutral and neutral). 
After presentation of the face pair for 500 ms, a probe (“<” or “>”) appears in the location of one of the 
faces. Participants are instructed to press the button (left or right, corresponding to the direction of the probe 
pointer). 
The task takes 5-10 minutes to complete. 
 
 
 
 
You can upload charts or diagrams if any
Criteria for Early Discontinuation  
Criteria for Early Discontinuation
Adherence and termination of study treatments
Adherence -- Rules of the treatment protocol will be carefully explained to patients by intake screeners and 
in consent forms. Patients who miss study visits will be actively followed up by phone and mail. Serious 
protocol violations, such as use of proscribed outside treatments or substance abuse, will be reviewed by the 
PI and will result in withdrawal from the study treatment. Substance use will be assessed by initial drug 
screen and subsequent patient report. If clinical suspicion of substance use arises based on erratic behavior, 
alcohol on breath, and other signs and symptoms, spot toxicology screens will be used. Treating 
psychiatrists will monitor patient drinking behavior with repeated queries over the course of treatment. If 
patients are withdrawn from the study treatments, staff will make every effort to make this event 
constructive and empathic. Patients will continue to be assessed for the full 12 weeks of the study. A pill 
count will be conducted after each visit to assess adherence to medication schedule. 
Criteria for removal from study treatment, including non-adherence. These will be defined as follows: a) 
patients who deteriorate in treatment, as defined during weeks 0-12 by CGI-I score > 5 and remain similarly 
impaired at re-assessment one week later; b) patients who commit serious violations of the protocol; and c) 


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patients who miss more than 3 consecutive days of medication or a total of 12 days within weeks 0-12. 
Patients who are non-adherent with a clinic visit will be contacted by the investigator to elucidate reasons 
for non-adherence.
Blood and other Biological Samples
Please create or insert a table describing the proposed collection of blood or other biological specimens
Prior to study entry, and at the week 12 visit, 25ml of blood will be drawn for: oxytocin levels, CBC, 
chemistry, thyroid tests, and in women, pregnancy test.  Urine will be obtained for drug screen and 
urinalysis.              
Assessment Instruments
Create a table or give a brief description of the instruments that will be used for assessment
(1 hour) Structured Clinical Interview for DSM IV (SCID-I) (First et al., 2002), used to determine 
Axis I disorders
(10 min) Structured Clinical Interview for Separation Anxiety Disorder (Cyranowski et al., 2002), modified 
for DSM-5. The eight separation anxiety disorder criteria are rated for both childhood (rated at baseline 
only) and past week time frames, scored as 0 (not at all), 1 (sometimes), 2 (often) or ? (don’t recall). In 
keeping with the DSM-5 guidelines, endorsement of three or more of the eight criterion symptoms 
(symptoms rated as ‘2’ or ‘often’) is used as a threshold to determine categorical (yes/no) diagnosis of 
separation anxiety disorder. Scores on each of the eight items are also summed to produce a continuous 
measure of separation anxiety symptoms experienced during childhood and adulthood (range for each 
scale=0–16).
(10 min) Hamilton Rating Scale for Depression (Hamilton, 1960) This standard scale will be used to assess 
severity of depression.
(10 min) Quality of Life Enjoyment & Satisfaction Questionnaire (Q-LES-Q, Endicott et al, 1993): self-
rated assessment of quality of life.
(5 min) Arizona Sexual Experiences Scale (ASEX) (McGahuey et al., 2000): will be used to assess 
sexual functioning as a self-rating.  It is a five-time rating scale and has been shown to have adequate 
internal consistency, test-retest reliability, and convergent and discriminant validity.
(5 min) Anxiety Sensitivity Index (Peterson and Reiss 1993): self-rated and measures anxiety 
sensitivity or fear of anxiety-related sensations
(1 min) Sheehan Disability Scale (Sheehan 1983): self-rated and assesses functional impairment in 
work/school, social life, and family life.
(10 min) Hamilton Anxiety Scale (Hamilton 1959): measures the severity of both psychic and somatic 
anxiety.  
(5 min) Clinical Global Impression-Improvement Scale (CGI-I), a quickly administered and widely used 
observer rating, will evaluate overall clinical status on a 1-7 point likert scale (Guy, 1976).
(5 min) Side Effect Checklist (SECL) A checklist of 27 symptoms commonly occurring as side effects to 
SSRIs will be rated on a 4-point anchored scale from 0-none to 3-severe.




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The is no treatment of known efficacy for ASAD, as there have been no reported clinical trials of 
medication of psychotherapy for this condition. However, based on studies of separation anxiety disorder in 
children, standard care might consist of cognitive-behavioral therapy or SSRI medication. The maximum 
duration of delay to standard care would be 17 weeks, as described above for subjects who needed a 5-week 
washout, and were then randomized to placebo.
 
Treatment to be provided at the end of the study
Three months of open medication treatment, including one month of free medication.
Clinical Treatment Alternatives
Clinical treatment alternatives
Based on studies of childhood separation anxiety disorder, the main treatment alternatives are cognitive-
behavioral therapy or SSRI medication.
Risks/Discomforts/Inconveniences 
Risks that could be encountered during the study period
a. Risks Associated with Treatment Procedures:
Medication Treatment: The most commonly reported side effects associated with therapeutic doses of 
vilazodone (incidence ≥ 5% and at least twice the rate of placebo) are: diarrhea, nausea, vomiting, and 
insomnia. Uncommon potential side effects include serotonin syndrome, increased bleeding, mania and low 
blood sodium. Suicidal ideation has been reported to sometimes be associated with antidepressant treatment. 
Vilazodone may have negative interactions with other medications a patient may take over the course of the 
study. 
Medication Discontinuation: Tapering of vilazodone that is too abrupt may lead to symptoms such as 
dizziness, sensory disturbances, agitation or anxiety, nausea and sweating. For patients who are tapered off 
study medication by study psychiatrists for any reason, tapering will be gradual and closely monitored.
Prohibited Treatments: An additional risk is that participants will not be able to benefit from all available 
treatments, as they will be prohibited from receiving other potentially helpful treatments during the study, 
including other psychotropic medications or initiating psychotherapy. 
Placebo: Patients have a 50% chance of being assigned to placebo for the 12 weeks. These participants will 
not be receiving active pharmacological treatment, and their condition could fail to improve or could worsen 
during this period.
Blind Treatment: Another risk is that participants will not be told whether they were assigned to vilazodone 
or placebo until completing the 14 week assessment period, except in the event of a medical emergency. 
This may delay or interfere with selection of optimal post-study treatments.


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b. Risks Associated with Assessment Procedures:
Venipuncture: Mild discomfort and, rarely, a small arm bruise, clot or infection may occur at the site of the 
blood drawing.
Self-Report Measures, Assessor Ratings: Patients could develop mild to moderate emotional discomfort or 
frustration associated with psychiatric interviewing or filling out questionnaires. 
Describe procedures for minimizing risks
To minimize treatment risks, patients will be screened for conditions that significantly increase risks of 
treatment, adverse effects and vital signs will be monitored at every visit, and dosing is flexible to allow 
reductions in the event of adverse effects. Patients will be educated about potential adverse interactions with 
other medications they may wish to take and advised to contact study physicians before starting new 
medications. Patients will be informed that they may withdraw from study treatment at any time. 
Randomization codes will be broken for patients upon their termination from the study, or earlier in the 
event of a medical emergency.
Venipuncture will be conducted with standard safety procedures.
Self-Report Measures, Assessor Ratings: Study clinicians are skilled at dealing with distress and will make 
efforts to help clients to feel as comfortable as possible (e.g., by giving breaks during an evaluation, offering 
encouragement).
Methods to Protect Confidentiality
Describe methods to protect confidentiality
All data with identifying information will be stored in locked file cabinets or password-protected computer 
files. Data being analyzed will be identified by subject codes and identifying information will be removed. 
The identity of patients will not be revealed in the presentation or publication of any results from the 
project. All assistants and others working on the project will be educated about the importance of strictly 
respecting patients' rights to confidentiality.
Will the study be conducted under a certificate of confidentiality?
No
Direct Benefits to Subjects  
Direct Benefits to Subjects
The potential direct benefit to patients who enter this study will be to obtain relief from ASAD symptoms to 
improve their quality of life. Vilazodone is an SSRI, and SSRIs have appeared efficacious for childhood 
separation anxiety disorder. Also, Vilazodone is FDA-approved for the treatment of depression, and it may 
be helpful for comorbid symptoms of depression in ASAD.


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Page 17 of 18
Compensation and/or Reimbursement 
Will compensation or reimbursement for expenses be offered to subjects?
Yes
Please describe and indicate total amount and schedule of payment(s). 
Include justification for compensation amounts and indicate if there are bonus payments.
Participants will receive $30/evaluation for completing each visit 2,3,4,5,6, and 7; $60/evaluation for 
completing each visit 1 and 8, to be paid by cash after each visit (maximum total of $300 over the 12 
weeks of the study).
Subjects will be paid for each of these assessments that are completed at the specified week, regardless of 
whether they are continuing on study treatment or not.
Uploads
Upload the entire grant application(s)
Upload copy(ies) of unbolded Consent Form(s)
CF unbolded 9.30.16.pdf
Upload copy(ies) of bolded Consent Form(s)
CF bolded 9.30.16.pdf
Upload copy(ies) of recruitment materials/ads to be reviewed
ads sep anxiety revision 1.pdf
ASAD ad 9.6.16.pdf
Sep_Anx_Ad_pull_tabs.pdf
Sep_Anx_Ad_loved_one.pdf
Vilaz_Paid_Craigslist_Posting_.pdf
Sep Anx Ad partner or spouse (no stamp).pdf
Sep Anx Ad child (no stamp).pdf
Upload copy(ies) of the HIPAA form
HIPAA_09.06.16.pdf
Upload any additional documents that may be related to this study
Continuation_memo.approved_pending.09.30.16.pdf
References
References
Bar-Haim Y. Research review: Attention bias modification (ABM): a novel treatment for anxiety 
disorders. J Child Psychol Psychiatry. 2010 Aug;51(8):859-70. 
 
Cyranowski JM, Shear MK, Rucci P, Fagiolini A, Frank E, Grochocinski VJ, et al. Adult separation anxiety: 
psychometric properties of a new structured clinical interview. Journal of psychiatric research.36:77-86. 


Protocol Summary Form
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Schneier, Franklin
Page 18 of 18
2002 Gabbard G. (ed.) Gabbard’s Treatments of Psychiatric Disorders, 5th Edition. American Psychiatric 
Publishing Inc, Washington, DC, In Press 
 
Feeney, J.A., Noller, P., & Hanrahan, M. (1994). Assessing adult attachment: Developments in the 
conceptualization of security and insecurity. In M.B. Sperling & W.H. Berman, Attachment in adults: 
Theory, assessment and treatment. pp. 128-152. New York: Guilford.
 
Kessler RC, McGonagle KA, Zhao S, Nelson CB, Hughes M, Eshleman S, Wittchen HU, Kendler KS. 
Lifetime and 12-month prevalence of DSM-III-R psychiatric disorders in the United States. Results from the 
National Comorbidity Survey. Arch Gen Psychiatry. 1994 Jan;51(1):8-19. 
 
Manicavasagar V., Silove D., Wagner R., Drobny J. A self-report questionnaire for measuring separation 
anxiety in adulthood (2003) Comprehensive Psychiatry, 44 (2) , pp. 146-153. 
 
Pini S, Gesi C, Abelli M, Muti M, Lari L, Cardini A, Manicavasagar V, Mauri M,Cassano GB, Shear KM. 
The relationship between adult separation anxiety disorder and complicated grief in a cohort of 454 
outpatients with mood and anxiety disorders. J Affect Disord. 2012 Dec 20;143(1-3):64-8. 
 
Shear K, Jin R, Ruscio AM, Walters EE, Kessler RC. Prevalence and correlates of estimated DSM-IV child 
and adult separation anxiety disorder in the National Comorbidity Survey Replication. Am J 
Psychiat.163:1074-83. 2006 
 
Simpson BS, Landsberg GM, Reisner IR, Ciribassi JJ, Horwitz D, Houpt KA, Kroll TL, Luescher A, Moffat 
KS, Douglass G, Robertson-Plouch C, Veenhuizen MF, Zimmerman A, Clark TP. Effects of reconcile 
(fluoxetine) chewable tablets plus behavior management for canine separation anxiety. Vet Ther. 2007 
Spring;8(1):18-31. 
 
Walkup JT, Albano AM, Piacentini J, Birmaher B, Compton SN, Sherrill JT, et al. Cognitive behavioral 
therapy, sertraline, or a combination in childhood anxiety. N Engl J Med.359:2753-66. 2008 Walkup, JT et 
al: Fluvoxamine for the treatment of anxiety disorders in children and adolescents. The Research Unit on 
Pediatric Psychopharmacology Anxiety Study Group.N Engl J Med. 344:1279-85. 2001 
 
Winslow JT, Insel TR. Serotonergic modulation of the rat pup ultrasonic isolation call: studies with 5HT1 
and 5HT2 subtype-selective agonists and antagonists. Psychopharmacology (Berl). 1991;105(4):513-20. 
 


 
 
        Relationship Anxiety Study 
 
Are you anxious about relationships? 
Worry about being separated from someone you care 
about? 
Find it hard to travel or sleep apart from someone you are 
close to? 
Worry about harm to people you are close to? 
Avoid being alone? 
Concerned you may be too clingy? 
Are these symptoms interfering with your life? 
 
 
 
 
If you are age 18-60, you may be eligible to participate in a research study of 
medication for treatment of an anxiety disorder. Eligible persons will receive 
payment for their participation. For more information please contact Rob at (646) 
774-8113 or valdovi@nyspi.columbia.edu. All calls are strictly confidential.   
 
    *Free Evaluation 
 
 
Anxiety Disorders Clinic 
New York State Psychiatric Institute/RFMH 
 
 
 
 
 
 
 
 
 
(646) 774-8113 
Separation Anxiety Study 
(646) 774-8113 
Separation Anxiety Study 
(646) 774-8113 
Separation Anxiety Study 
(646) 774-8113 
Separation Anxiety Study 
(646) 774-8113 
Separation Anxiety Study 
(646) 774-8113 
Separation Anxiety Study 
(646) 774-8113 
Separation Anxiety Study 
(646) 774-8113 
Separation Anxiety Study 
(646) 774-8113 
Separation Anxiety Study 
(646) 774-8113 
Separation Anxiety Study 
(646) 774-8113 
Separation Anxiety Study 
(646) 774-8113 
Separation Anxiety Study 
(646) 774-8113 
Separation Anxiety Study 
 


 
 
Do You Have Separation Anxiety? 
 
Do you constantly worry about your loved ones? 
Concerned about being separated from someone you care about? 
Experience excessive stress when anticipating separation from 
attachment figures or home? 
Find it hard to travel or sleep apart from those you are close to? 
Worry about harm to people you are close to? 
Avoid being alone? 
Concerned you may be too clingy? 
Are these symptoms interfering with your life? 
 
 
 
If you are between the ages of 18-60 and are suffering from some of these 
conditions, you may be eligible to participate in a paid research study of 
medication for treatment of separation anxiety disorder. Eligible persons will 
receive payment for their participation. Please call for more information. All calls 
are strictly confidential.   
 
 
    *Free Evaluation 
 
 
 
 
 
 
Anxiety Disorders Clinic 
New York State Psychiatric Institute/RFMH 
(646) 774-8113 
dmoskow@nyspi.columbia.edu 


 
 
         Do You Have Separation Anxiety? 
 
Do you constantly worry about your loved ones? 
Concerned about being separated from someone you 
care about? 
Experience excessive stress when anticipating separation 
from attachment figures or home? 
Find it hard to travel or sleep apart from those you are 
close to? 
Avoid being alone? 
Worry about harm to people you are close to? 
Concerned you may be too clingy? 
Are these symptoms interfering with your life? 
 
 
 
 
If you are between the ages of 18-60 and are suffering from some of these 
conditions, you may be eligible to participate in a paid research study of 
medication for treatment of Separation Anxiety Disorder in adults. Eligible 
persons will receive payment for their participation. For more information please 
contact Danielle at (646) 774-8113 or dmoskow@nyspi.columbia.edu. All calls 
are strictly confidential.   
 
    *Free Evaluation 
 
 
Anxiety Disorders Clinic 
New York State Psychiatric Institute/RFMH 
 
 
 
 
 
 
 
 


 
646-774-8113 
Separation Anxiety Study 
646-774-8113 
Separation Anxiety Study 
646-774-8113 
Separation Anxiety Study 
646-774-8113 
Separation Anxiety Study 
646-774-8113 
Separation Anxiety Study 
646-774-8113 
Separation Anxiety Study 
646-774-8113 
Separation Anxiety Study 
646-774-8113 
Separation Anxiety Study 
646-774-8113 
Separation Anxiety Study 
646-774-8113 
Separation Anxiety Study 
646-774-8113 
Separation Anxiety Study 
646-774-8113 
Separation Anxiety Study 
646-774-8113 
Separation Anxiety Study 
 




09/06/2016 IRB #6856   
  
  
  
Sponsor: Forest Laboratories   
Principal Investigator: Franklin Schneier, M.D  
  
  
  
2  
Your Rights: Your participation is voluntary, and you may withdraw from the study at any  
time and seek alternative treatment if you wish.  
  
CONSENT FORM  
Vilazodone for Separation Anxiety Disorder in Adults  
  
Contact for questions and emergencies   
Dr. Franklin Schneier or your study doctor is available to answer your questions at any 
time. They can be reached during the day at (646) 774-7000. After 5 PM you can page 
the  
Anxiety Clinic Doctor on Call at (917) 996-6939. Dr. Schneier can be reached by mail at 
Unit 69, 1051 Riverside Drive, New York, NY 10032.  
  
PURPOSE OF STUDY  
You are being asked to participate in this research study because you are an adult with 
Separation Anxiety Disorder. This study compares the effectiveness of vilazodone (brand 
name Viibryd) to placebo in the treatment of 40 persons with Separation Anxiety Disorder. 
The placebo looks like the other pill, but does not contain any medicine (it is sometimes 
called a “sugar pill”). There are no published studies of treatments for adults with  
Separation Anxiety Disorder and no medications approved for this condition. Vilazodone 
is a medication that is FDA-approved for the treatment of depression but has not been 
studied for Separation Anxiety Disorder. This study is sponsored by Forest Laboratories, 
the manufacturer of vilazodone.  
  
ALTERNATIVE TREATMENTS  
You do not have to participate in this study to receive treatment for Separation Anxiety 
Disorder. Vilazodone is available by prescription and can be prescribed by your regular 
medical doctor. Other treatments for Separation Anxiety Disorder include psychotherapy 
such as cognitive behavioral therapy, and off-label use of antidepressants, such as 


09/06/2016 IRB #6856   
  
  
  
Sponsor: Forest Laboratories   
Principal Investigator: Franklin Schneier, M.D  
  
  
  
3  
paroxetine (brand name Paxil) or sertraline (brand name Zoloft). Your doctor will discuss 
benefits, risks and side effects of study participation with you. The alternative to 
participating in this study would be to get treatment elsewhere without the research 
interviews and procedures, and without the possibility of getting a placebo.       
  
STUDY PROCEDURES  
This study involves your taking study pills daily, and visiting the Anxiety Disorders Clinic up 
to 8 times (total of 4-1/2 hours) over 12 weeks. You will be assigned at random (flip of a 
coin, with a 50/50 chance for each) to take either vilazodone or placebo. Neither you nor 
the researchers will know if you are getting the placebo (inactive pill), but they can find out 
in an emergency.    
You have already met with your study doctor to discuss your medical and 
psychiatric condition. In addition, you were asked standard questions and received a 
medical exam, including blood and urine tests, a urine drug screen and an 
electrocardiogram (EKG).  
You will need to be off all psychiatric medication for at least two weeks before 
starting study treatment, except for the sleep medication zolpidem (brand name Ambien 
or Ambin CR). If you have been taking zolpidem consistently over the four weeks prior to 
study treatment, you will be allowed to continue using it during the study. During the study 
you should not take any medication nor receive any psychotherapy without approval of 
your study doctor.   
If you are taking a medication that has been helpful but is not allowed in the study, 
you cannot participate in the study. If you are on medication that has not been helpful and 
is not allowed in the study, your study doctor will ask your permission to contact your 
treating doctor. If you agree, the medication will be stopped in consultation with your 
treating doctor. You will be monitored with weekly visits during this period. If you are on 
medication that has not been helpful and you do not want your treating doctor to be 
contacted, you will not be able to participate in this study.   


09/06/2016 IRB #6856   
  
  
  
Sponsor: Forest Laboratories   
Principal Investigator: Franklin Schneier, M.D  
  
  
  
4  
To participate in this study, you must agree to avoid using alcoholic beverages or 
recreational drugs during the study, because they might cause problems if combined with 
your medication. You must also agree to avoid starting psychotherapy during the study, 
because it could interfere with evaluating the study medications.  
  
Study Treatment  
You will see your study doctor for about 30 minutes weekly for two weeks, and then every 
other week for six weeks, and then four weeks later. At each visit your study doctor will 
ask about any improvements or side effects that you have noticed. The doctor will adjust 
the dose of the medicine to try to maximize your improvement. The doctor will give you 
study medication (vilazodone or placebo), which you should take as instructed. The 
medication should not be taken by anyone else, and it should be kept in a safe place out 
of the reach of children.   
You will also be asked about your symptoms by a study rater at each visit. You will 
also be asked to complete questionnaires at each visit. At three of the study visits, you will 
also be asked to sit at a computer monitor for about 10 minutes and view pictures of faces 
and then a pointer (“<” or “>”). You will be asked to press a left or right button, depending 
on the direction of the pointer.   
After 12 weeks of treatment, you will complete the same medical exam you 
received at the beginning of treatment (physical exam, blood tests [equivalent of two 
tablespoons], urine tests, EKG). If you are discontinuing study medication you will be 
given instructions on how to reduce it gradually.  
  
The doctor in charge of the study can remove you from the study without your 
consent for one of the following reasons:  
• 
If in his judgment, you need an alternative treatment.  
• 
If you fail to follow the study rules.   
• 
If your condition significantly worsens during the study.  
  


09/06/2016 IRB #6856   
  
  
  
Sponsor: Forest Laboratories   
Principal Investigator: Franklin Schneier, M.D  
  
  
  
5  
Treatment After You End Study Treatment   
At the time you end study treatment you will be offered further treatment in the clinic with 
vilazodone or with another medication if recommended by your clinic doctor, for three 
months. All visits with your doctor will be free of charge for three months. Medication will 
be free of charge for the first month, and after that you may have to pay for your 
medication. After three months you will be referred for follow-up care if needed. If at any 
time after you end study treatment you would like treatment other than medication you 
can be referred to such treatment. You can get such treatment while you are receiving the 
three months of after-study medication treatment offered in the clinic.   
     When you leave the study, an Anxiety Disorders Clinic doctor will meet with you, 
inform you whether you were taking vilazodone or placebo during the study, and answer 
any questions you may have about this.  
  
RISKS  
Study Treatments: The main risk of this study is that the research treatments may not 
help your symptoms. Even if you receive vilazodone, it may not help your Separation 
Anxiety Disorder, and your symptoms may get worse. A common treatment for Separation 
Anxiety Disorder includes psychotherapy such as cognitive-behavioral therapy, but it may 
be up to 17 weeks from the time you enter the study until you would be provided with 
psychotherapy or another type of treatment, such as other medications. Additionally, 
because you will not find out whether you have been taking vilazodone or placebo until 
you leave the study (except in the event of an emergency), decisions about your 
treatment during the study will not be able to take that information into account.  
Other possible risks to you are the side effects that some people get from 
vilazodone. You should not drive or operate complex or heavy machinery if study 
medication is affecting your thinking or reflexes. Side effects that may occur include 
sweating, rash, nausea, vomiting, increased or decreased appetite, weight loss or gain, 
sleepiness, fatigue, insomnia, dizziness, nervousness, cough, running nose, dry mouth, 
muscular tremors, changes in heart rate, elevated mood, and sexual problems, including 


09/06/2016 IRB #6856   
  
  
  
Sponsor: Forest Laboratories   
Principal Investigator: Franklin Schneier, M.D  
  
  
  
6  
loss of interest for both sexes, difficulty having orgasm in women, and difficulty having an 
erection or ejaculating in men. Vilazodone may cause unexpected problems if combined 
with other medications you might take during the study.    
Stopping vilazodone too rapidly may cause dizziness, agitation or anxiety, nausea 
and sweating. These symptoms usually resolve over time. You should not stop study 
medication before discussing it with your study doctor.  
While vilazodone is considered to be a safe treatment, the Food and Drug  
Administration (FDA) has issued a public health advisory about a possible link, in rare 
cases, between suicidal thoughts or behavior in patients treated with antidepressant 
medications (including vilazodone). The FDA has asked health care providers and 
patients to note that worsening of depression could be related to the underlying disease 
process, or in some cases, might be a direct result of antidepressant drug treatment.  At 
the present time, the FDA has not concluded that these drugs cause worsening 
depressive symptoms or suicidal ideation or behavior, and this is an area of active 
research. The FDA advisory urges careful monitoring of patients receiving these 
medications during the beginning stage of therapy and during increases or decreases in 
dosage.  
To minimize risks of study treatment, you have been checked for conditions that 
can increase risks of treatment, and you will be closely monitored for side effects at every 
visit. A study doctor will be available by pager 24 hours/day. Your study doctor can adjust 
the doses of study medications to minimize side effects. If you need to take any other 
medications during the study, you should first contact your study doctor to minimize the 
risk of drug interactions. You may leave the study at any time. In the event of a medical 
emergency, your doctor will be able to find out what medication you have been taking 
during the study.  
  
For women:  You should not be in this study if you are pregnant.  Women who take 
vilazodone during pregnancy or who become pregnant while taking it may be at greater 
risk of having a baby born with a birth defect. You must agree to use birth control 


09/06/2016 IRB #6856   
  
  
  
Sponsor: Forest Laboratories   
Principal Investigator: Franklin Schneier, M.D  
  
  
  
7  
throughout the course of your treatment with medication. If you decide to stop using birth 
control, or if there is a possibility that you are pregnant during the study, you must tell your 
study doctor immediately so that a pregnancy test can be done, and we can decide 
whether you should continue in the study.  
  
Blood Drawing may cause mild discomfort and, rarely, a small arm bruise, clot or infection 
may occur at the site.  
Ratings: You may feel mild to moderate upset or frustration due to answering questions 
about your life or filling out questionnaires. Study staff are skilled at dealing with these 
events and will try to help you feel as comfortable as possible (e.g., by giving breaks 
during an evaluation, offering encouragement).  
  
  
BENEFITS:  
A direct benefit to you is the possibility that the research treatment may help your 
Separation Anxiety Disorder symptoms.  In addition, your participation may help 
researchers learn more about how to treat Separation Anxiety Disorder. There may be no 
benefit to you if the treatment is not effective.    
  
COMPENSATION:  
You will receive $60 for each of the first and last visits, and $30 for each of the 6 interim 
visits you complete, to be paid in cash after the completion of each visit (up to $300 total), 
as payment for your time. You will be paid for each of these visits that you complete on 
schedule, whether or not you are continuing on study treatment.  
  
CONFIDENTIALITY:   
All records related to the study are confidential, although state and federal agency, and 
Forest Laboratories personnel may inspect records. Similarly, there are legal advocacy 
organizations that have the authority under the law to access otherwise confidential 


09/06/2016 IRB #6856   
  
  
  
Sponsor: Forest Laboratories   
Principal Investigator: Franklin Schneier, M.D  
  
  
  
8  
subject records. They cannot re-disclose this information without the subject’s consent. All 
records will be confidential to the extent permitted by law. Your records will be kept in 
locked files and access will be allowed only to members of the research team, or 
institutional personnel as part of a routine audit. Should any of the information gathered 
from you be used for scientific publications or presentations, you will be protected through 
the use of a system of codes that will not reveal the identity of individuals. Any report 
based on this study will only be used as grouped information without mention or 
description of the individual participants.   
         Your name and other personal identifying information will be stored in an 
electronically secure database at New York State Psychiatric Institute. Research data that 
is entered into the computer will be stored according to study ID number. A master list 
linking the patient name to the assigned ID number is kept in a separate file. To access 
the computer and appropriate data files, the staff member must have knowledge of the 
password and be given rights to access the data by the data manager. All data that is 
transmitted via computer is encoded and identifying information is removed.  
        A description of this clinical trial will be available on http://www.ClinicalTrials.gov , as 
required by U.S. Law. This Web site will not include information that can identify you. At 
most, the Web site will include a summary of the results. You can search this Web site at 
any time.  
  
RESEARCH STANDARDS AND PARTICIPANTS’ RIGHTS:  
Participation in this research study is voluntary. If you decide not to participate, or if you 
later decide to stop participating, you will not lose any benefits to which you are otherwise 
entitled. A decision not to participate will not effect your treatment at the New York 
Psychiatric Institute. The doctors participating in this research study are also responsible 
for your clinical care in the Anxiety Disorders Clinic, even after you end the study. You will 
be notified of significant new findings that may relate to your willingness to continue to 
participate in the study.  
  


09/06/2016 IRB #6856   
  
  
  
Sponsor: Forest Laboratories   
Principal Investigator: Franklin Schneier, M.D  
  
  
  
9  
Medical Compensation for Research-Related Injuries  
Federal regulations require that you be informed about the institution's policy with regard 
to compensation and payment for treatment of research-related injuries. Short term 
emergency medical treatment, which has been determined to be necessary by New York  
State Psychiatric Institute's doctors, and which is within the capability of New York State 
Psychiatric Institute will be provided.  In addition, you will be provided assistance in 
arranging follow up care in such instances.  
  
New York State Psychiatric Institute and Research Foundation for Mental Hygiene 
do not provide compensation or payment for treatment of research related injuries. 
However, you should be aware that participation in this research does not waive any of 
your legal rights to seek such compensation through the courts.  
  
Dr. Schneier or your study doctor is available to answer your questions about the 
study at any time.  They can be reached during the day at (646) 774-7000.  After 5 PM 
you can page the Anxiety Clinic Doctor on Call at (917) 996-6939.  In addition, an 
emergency psychiatric consultation is always available to you by calling these numbers.  
The doctors participating in this research study are also responsible for your clinical care.    
 If you have any questions about your rights as a research participant or any complaints, 
you may call the NYSPI-IRB Main Office at (646) 774-7155 during regular office hours.  
  
You will be given a copy of the signed Consent Form to keep.   
  
 
 
 
STATEMENT OF CONSENT  
I voluntarily agree to participate in the research study described above.    


09/06/2016 IRB #6856   
  
  
  
Sponsor: Forest Laboratories   
Principal Investigator: Franklin Schneier, M.D  
  
  
  
10  
  
NAME                                                      (print)  
  
Date________________ Signature ________________________________                                    
  
  
  
   
  
  
  
Study Participant  
I have discussed the proposed research with the patient, and in my opinion, this patient 
understands the benefits, risks and alternatives (including non-participation) and is 
capable of freely consenting to participate in this research.  
  
NAME                                                      (print)  
  
Date                               Signature________________________________                                       
                        
  
  
  
  
Study Physician  
  


 
 
Page 1 of 1 
INSTITUTIONAL REVIEW BOARD 
NEW YORK STATE PSYCHIATRIC INSTITUTE 
 
MEMORANDUM 
 
 
 
 
 
 
 
 
 
 
 
September 30, 2016  
TO: 
 
Dr. Franklin Schneier 
 
FROM: 
Dr. Edward Nunes, IRB Co-Chair 
 
SUBJECT: 
Protocol #6856: VILAZODONE FOR SEPARATION ANXIETY DISORDER IN ADULTS 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
The Full Board reviewed the above protocol continuation application on September 26, 2016 and 
recommended approval pending your response to the following items.  Please submit (through 
PRISM) (1) a copy of this memo, (2) your point-by-point response (question and answer 
format), (3) the revised Protocol Summary Form (PSF) with revisions bolded, (4) the 
Consent Forms (CF). 
 
1. Please remove from the Questions section of the CF, “The NYSPI IRB has approved 
recruitment for this study.” This is no longer approved template language. 
2. Please revise the IRB contact information in the Questions section of the CF: 
You may call the IRB Main Office at (646)774-7155 during regular office hours.  
 
 
 
 
EN/alw 


 
 
         Adult Separation Anxiety Study 
 
 
Is someone you love: 
Too clingy? 
Overly anxious when separated from you? 
Constantly contacting you? 
Worrying a lot about harm coming to you? 
Overprotective? 
Afraid to be alone or travel alone? 
 
Do these symptoms cause problems in his or her life? 
 
 
 
 
Individuals ages 18-60 who have some of these symptoms may be eligible to 
participate in a paid research study of medication for treatment of Separation 
Anxiety Disorder in adults. Eligible persons will receive payment for their 
participation. For more information please contact Danielle at (646) 774-8113 or 
dmoskow@nyspi.columbia.edu to arrange a free evaluation. All calls are strictly 
confidential.   
 
 
 
 
Anxiety Disorders Clinic 
New York State Psychiatric Institute/RFMH 
 
 
 
 
 
 
646-774-8113 
Separation Anxiety Study 
646-774-8113 
Separation Anxiety Study 
646-774-8113 
Separation Anxiety Study 
646-774-8113 
Separation Anxiety Study 
646-774-8113 
Separation Anxiety Study 
646-774-8113 
Separation Anxiety Study 
646-774-8113 
Separation Anxiety Study 
646-774-8113 
Separation Anxiety Study 
646-774-8113 
Separation Anxiety Study 
646-774-8113 
Separation Anxiety Study 
646-774-8113 
Separation Anxiety Study 
646-774-8113 
Separation Anxiety Study 
646-774-8113 
Separation Anxiety Study 
 


Vilazodone for Separation Anxiety in Adults (IRB# 6856) 
Please note that this is an opportunity to participate in research for compensation and is not a job 
posting. 
 
Do you worry too much when separated from loved ones? 
 
We are looking for individuals with adult separation anxiety disorder (ASAD) to participate in a 
research treatment study.  People with ASAD worry about people close to them coming to 
serious harm and may imagine the worst when they are apart. 
 
This study aims to establish effective treatments for ASAD, based on what is known about the 
causes of separation anxiety and about treatments known to help related conditions.  All 
information will be kept strictly confidential. 
 
WHO CAN PARTICIPATE: 
x People between the ages of 18 and 60 suffering primarily from adult separation anxiety 
disorder, who are not on any psychiatric medications, and who are able to travel to the 
New York State Psychiatric Institute/Columbia University Medical Center (1051 
Riverside Drive) in Manhattan 
 
COMPENSATION FOR PARTICIPATION: 
x Total of $300, paid in installments at the end of each visit to our clinic (8 visits, total) 
 
PROCEDURES: 
1) Screening by phone (time estimate: 25 minutes) 
2) If potentially eligible, an in-person psychiatric evaluation, clinical assessment, and 
standard health assessment (time estimate: 2 hours) 
3) If eligible, 7 treatment visits to our clinic over a 12-week period (time estimate: 30-45 
minutes each visit) 
 
This is not a part-time job. Compensation is being provided for participation in a research study. 
 
FOR MORE INFORMATION, PLEASE CONTACT: 
Anxiety Disorders Clinic, Columbia University Medical Center  
(646) 774-8113 or e-mail valdovi@nyspi.columbia.edu 
 
 


 
 
         Adult Separation Anxiety Study 
 
Are you anxious when separated from your partner or spouse? 
Are you constantly contacting your partner or spouse? 
Worry a lot about harm coming to your partner or spouse? 
Do you worry excessively when your partner or spouse travels? 
Does your partner or spouse say you are overprotective? 
Avoid activities that involve separation from your partner or 
spouse? 
Fear being alone? 
Are these symptoms interfering with your life? 
 
 
 
 
If you are age 18-60, you may be eligible to participate in a research study of 
medication for treatment of Separation Anxiety Disorder in adults. Eligible 
persons will receive payment for their participation. For more information please 
contact Rob at (646) 774-8113 or valdovi@nyspi.columbia.edu. All calls are 
strictly confidential.   
 
    *Free Evaluation 
 
 
Anxiety Disorders Clinic 
New York State Psychiatric Institute/RFMH 
 
 
 
 
 
 
 
 
646-774-8113 
Separation Anxiety Study 
646-774-8113 
Separation Anxiety Study 
646-774-8113 
Separation Anxiety Study 
646-774-8113 
Separation Anxiety Study 
646-774-8113 
Separation Anxiety Study 
646-774-8113 
Separation Anxiety Study 
646-774-8113 
Separation Anxiety Study 
646-774-8113 
Separation Anxiety Study 
646-774-8113 
Separation Anxiety Study 
646-774-8113 
Separation Anxiety Study 
646-774-8113 
Separation Anxiety Study 
646-774-8113 
Separation Anxiety Study 
646-774-8113 
Separation Anxiety Study 
 




09/30/2016 IRB #6856   
  
  
  
Sponsor: Forest Laboratories   
Principal Investigator: Franklin Schneier, M.D  
  
  
  
2  
Your Rights: Your participation is voluntary, and you may withdraw from the study at any  
time and seek alternative treatment if you wish.  
  
CONSENT FORM  
Vilazodone for Separation Anxiety Disorder in Adults  
  
Contact for questions and emergencies   
Dr. Franklin Schneier or your study doctor is available to answer your questions at any 
time. They can be reached during the day at (646) 774-7000. After 5 PM you can page 
the  
Anxiety Clinic Doctor on Call at (917) 996-6939. Dr. Schneier can be reached by mail at 
Unit 69, 1051 Riverside Drive, New York, NY 10032.  
  
PURPOSE OF STUDY  
You are being asked to participate in this research study because you are an adult with 
Separation Anxiety Disorder. This study compares the effectiveness of vilazodone (brand 
name Viibryd) to placebo in the treatment of 40 persons with Separation Anxiety Disorder. 
The placebo looks like the other pill, but does not contain any medicine (it is sometimes 
called a “sugar pill”). There are no published studies of treatments for adults with  
Separation Anxiety Disorder and no medications approved for this condition. Vilazodone 
is a medication that is FDA-approved for the treatment of depression but has not been 
studied for Separation Anxiety Disorder. This study is sponsored by Forest Laboratories, 
the manufacturer of vilazodone.  
  
ALTERNATIVE TREATMENTS  
You do not have to participate in this study to receive treatment for Separation Anxiety 
Disorder. Vilazodone is available by prescription and can be prescribed by your regular 
medical doctor. Other treatments for Separation Anxiety Disorder include psychotherapy 
such as cognitive behavioral therapy, and off-label use of antidepressants, such as 


09/30/2016 IRB #6856   
  
  
  
Sponsor: Forest Laboratories   
Principal Investigator: Franklin Schneier, M.D  
  
  
  
3  
paroxetine (brand name Paxil) or sertraline (brand name Zoloft). Your doctor will discuss 
benefits, risks and side effects of study participation with you. The alternative to 
participating in this study would be to get treatment elsewhere without the research 
interviews and procedures, and without the possibility of getting a placebo.       
  
STUDY PROCEDURES  
This study involves your taking study pills daily, and visiting the Anxiety Disorders Clinic up 
to 8 times (total of 4-1/2 hours) over 12 weeks. You will be assigned at random (flip of a 
coin, with a 50/50 chance for each) to take either vilazodone or placebo. Neither you nor 
the researchers will know if you are getting the placebo (inactive pill), but they can find out 
in an emergency.    
You have already met with your study doctor to discuss your medical and 
psychiatric condition. In addition, you were asked standard questions and received a 
medical exam, including blood and urine tests, a urine drug screen and an 
electrocardiogram (EKG).  
You will need to be off all psychiatric medication for at least two weeks before 
starting study treatment, except for the sleep medication zolpidem (brand name Ambien 
or Ambin CR). If you have been taking zolpidem consistently over the four weeks prior to 
study treatment, you will be allowed to continue using it during the study. During the study 
you should not take any medication nor receive any psychotherapy without approval of 
your study doctor.   
If you are taking a medication that has been helpful but is not allowed in the study, 
you cannot participate in the study. If you are on medication that has not been helpful and 
is not allowed in the study, your study doctor will ask your permission to contact your 
treating doctor. If you agree, the medication will be stopped in consultation with your 
treating doctor. You will be monitored with weekly visits during this period. If you are on 
medication that has not been helpful and you do not want your treating doctor to be 
contacted, you will not be able to participate in this study.   


09/30/2016 IRB #6856   
  
  
  
Sponsor: Forest Laboratories   
Principal Investigator: Franklin Schneier, M.D  
  
  
  
4  
To participate in this study, you must agree to avoid using alcoholic beverages or 
recreational drugs during the study, because they might cause problems if combined with 
your medication. You must also agree to avoid starting psychotherapy during the study, 
because it could interfere with evaluating the study medications.  
  
Study Treatment  
You will see your study doctor for about 30 minutes weekly for two weeks, and then every 
other week for six weeks, and then four weeks later. At each visit your study doctor will 
ask about any improvements or side effects that you have noticed. The doctor will adjust 
the dose of the medicine to try to maximize your improvement. The doctor will give you 
study medication (vilazodone or placebo), which you should take as instructed. The 
medication should not be taken by anyone else, and it should be kept in a safe place out 
of the reach of children.   
You will also be asked about your symptoms by a study rater at each visit. You will 
also be asked to complete questionnaires at each visit. At three of the study visits, you will 
also be asked to sit at a computer monitor for about 10 minutes and view pictures of faces 
and then a pointer (“<” or “>”). You will be asked to press a left or right button, depending 
on the direction of the pointer.   
After 12 weeks of treatment, you will complete the same medical exam you 
received at the beginning of treatment (physical exam, blood tests [equivalent of two 
tablespoons], urine tests, EKG). If you are discontinuing study medication you will be 
given instructions on how to reduce it gradually.  
  
The doctor in charge of the study can remove you from the study without your 
consent for one of the following reasons:  
• 
If in his judgment, you need an alternative treatment.  
• 
If you fail to follow the study rules.   
• 
If your condition significantly worsens during the study.  
  


09/30/2016 IRB #6856   
  
  
  
Sponsor: Forest Laboratories   
Principal Investigator: Franklin Schneier, M.D  
  
  
  
5  
Treatment After You End Study Treatment   
At the time you end study treatment you will be offered further treatment in the clinic with 
vilazodone or with another medication if recommended by your clinic doctor, for three 
months. All visits with your doctor will be free of charge for three months. Medication will 
be free of charge for the first month, and after that you may have to pay for your 
medication. After three months you will be referred for follow-up care if needed. If at any 
time after you end study treatment you would like treatment other than medication you 
can be referred to such treatment. You can get such treatment while you are receiving the 
three months of after-study medication treatment offered in the clinic.   
     When you leave the study, an Anxiety Disorders Clinic doctor will meet with you, 
inform you whether you were taking vilazodone or placebo during the study, and answer 
any questions you may have about this.  
  
RISKS  
Study Treatments: The main risk of this study is that the research treatments may not 
help your symptoms. Even if you receive vilazodone, it may not help your Separation 
Anxiety Disorder, and your symptoms may get worse. A common treatment for Separation 
Anxiety Disorder includes psychotherapy such as cognitive-behavioral therapy, but it may 
be up to 17 weeks from the time you enter the study until you would be provided with 
psychotherapy or another type of treatment, such as other medications. Additionally, 
because you will not find out whether you have been taking vilazodone or placebo until 
you leave the study (except in the event of an emergency), decisions about your 
treatment during the study will not be able to take that information into account.  
Other possible risks to you are the side effects that some people get from 
vilazodone. You should not drive or operate complex or heavy machinery if study 
medication is affecting your thinking or reflexes. Side effects that may occur include 
sweating, rash, nausea, vomiting, increased or decreased appetite, weight loss or gain, 
sleepiness, fatigue, insomnia, dizziness, nervousness, cough, running nose, dry mouth, 
muscular tremors, changes in heart rate, elevated mood, and sexual problems, including 


09/30/2016 IRB #6856   
  
  
  
Sponsor: Forest Laboratories   
Principal Investigator: Franklin Schneier, M.D  
  
  
  
6  
loss of interest for both sexes, difficulty having orgasm in women, and difficulty having an 
erection or ejaculating in men. Vilazodone may cause unexpected problems if combined 
with other medications you might take during the study.    
Stopping vilazodone too rapidly may cause dizziness, agitation or anxiety, nausea 
and sweating. These symptoms usually resolve over time. You should not stop study 
medication before discussing it with your study doctor.  
While vilazodone is considered to be a safe treatment, the Food and Drug  
Administration (FDA) has issued a public health advisory about a possible link, in rare 
cases, between suicidal thoughts or behavior in patients treated with antidepressant 
medications (including vilazodone). The FDA has asked health care providers and 
patients to note that worsening of depression could be related to the underlying disease 
process, or in some cases, might be a direct result of antidepressant drug treatment.  At 
the present time, the FDA has not concluded that these drugs cause worsening 
depressive symptoms or suicidal ideation or behavior, and this is an area of active 
research. The FDA advisory urges careful monitoring of patients receiving these 
medications during the beginning stage of therapy and during increases or decreases in 
dosage.  
To minimize risks of study treatment, you have been checked for conditions that 
can increase risks of treatment, and you will be closely monitored for side effects at every 
visit. A study doctor will be available by pager 24 hours/day. Your study doctor can adjust 
the doses of study medications to minimize side effects. If you need to take any other 
medications during the study, you should first contact your study doctor to minimize the 
risk of drug interactions. You may leave the study at any time. In the event of a medical 
emergency, your doctor will be able to find out what medication you have been taking 
during the study.  
  
For women:  You should not be in this study if you are pregnant.  Women who take 
vilazodone during pregnancy or who become pregnant while taking it may be at greater 
risk of having a baby born with a birth defect. You must agree to use birth control 


09/30/2016 IRB #6856   
  
  
  
Sponsor: Forest Laboratories   
Principal Investigator: Franklin Schneier, M.D  
  
  
  
7  
throughout the course of your treatment with medication. If you decide to stop using birth 
control, or if there is a possibility that you are pregnant during the study, you must tell your 
study doctor immediately so that a pregnancy test can be done, and we can decide 
whether you should continue in the study.  
  
Blood Drawing may cause mild discomfort and, rarely, a small arm bruise, clot or infection 
may occur at the site.  
Ratings: You may feel mild to moderate upset or frustration due to answering questions 
about your life or filling out questionnaires. Study staff are skilled at dealing with these 
events and will try to help you feel as comfortable as possible (e.g., by giving breaks 
during an evaluation, offering encouragement).  
  
  
BENEFITS:  
A direct benefit to you is the possibility that the research treatment may help your 
Separation Anxiety Disorder symptoms.  In addition, your participation may help 
researchers learn more about how to treat Separation Anxiety Disorder. There may be no 
benefit to you if the treatment is not effective.    
  
COMPENSATION:  
You will receive $60 for each of the first and last visits, and $30 for each of the 6 interim 
visits you complete, to be paid in cash after the completion of each visit (up to $300 total), 
as payment for your time. You will be paid for each of these visits that you complete on 
schedule, whether or not you are continuing on study treatment.  
  
CONFIDENTIALITY:   
All records related to the study are confidential, although state and federal agency, and 
Forest Laboratories personnel may inspect records. Similarly, there are legal advocacy 
organizations that have the authority under the law to access otherwise confidential 


09/30/2016 IRB #6856   
  
  
  
Sponsor: Forest Laboratories   
Principal Investigator: Franklin Schneier, M.D  
  
  
  
8  
subject records. They cannot re-disclose this information without the subject’s consent. All 
records will be confidential to the extent permitted by law. Your records will be kept in 
locked files and access will be allowed only to members of the research team, or 
institutional personnel as part of a routine audit. Should any of the information gathered 
from you be used for scientific publications or presentations, you will be protected through 
the use of a system of codes that will not reveal the identity of individuals. Any report 
based on this study will only be used as grouped information without mention or 
description of the individual participants.   
         Your name and other personal identifying information will be stored in an 
electronically secure database at New York State Psychiatric Institute. Research data that 
is entered into the computer will be stored according to study ID number. A master list 
linking the patient name to the assigned ID number is kept in a separate file. To access 
the computer and appropriate data files, the staff member must have knowledge of the 
password and be given rights to access the data by the data manager. All data that is 
transmitted via computer is encoded and identifying information is removed.  
        A description of this clinical trial will be available on http://www.ClinicalTrials.gov , as 
required by U.S. Law. This Web site will not include information that can identify you. At 
most, the Web site will include a summary of the results. You can search this Web site at 
any time.  
  
RESEARCH STANDARDS AND PARTICIPANTS’ RIGHTS:  
Participation in this research study is voluntary. If you decide not to participate, or if you 
later decide to stop participating, you will not lose any benefits to which you are otherwise 
entitled. A decision not to participate will not effect your treatment at the New York 
Psychiatric Institute. The doctors participating in this research study are also responsible 
for your clinical care in the Anxiety Disorders Clinic, even after you end the study. You will 
be notified of significant new findings that may relate to your willingness to continue to 
participate in the study.  
  


09/30/2016 IRB #6856   
  
  
  
Sponsor: Forest Laboratories   
Principal Investigator: Franklin Schneier, M.D  
  
  
  
9  
Medical Compensation for Research-Related Injuries  
Federal regulations require that you be informed about the institution's policy with regard 
to compensation and payment for treatment of research-related injuries. Short term 
emergency medical treatment, which has been determined to be necessary by New York  
State Psychiatric Institute's doctors, and which is within the capability of New York State 
Psychiatric Institute will be provided.  In addition, you will be provided assistance in 
arranging follow up care in such instances.  
  
New York State Psychiatric Institute and Research Foundation for Mental Hygiene 
do not provide compensation or payment for treatment of research related injuries. 
However, you should be aware that participation in this research does not waive any of 
your legal rights to seek such compensation through the courts.  
  
Dr. Schneier or your study doctor is available to answer your questions about the 
study at any time.  They can be reached during the day at (646) 774-7000.  After 5 PM 
you can page the Anxiety Clinic Doctor on Call at (917) 996-6939.  In addition, an 
emergency psychiatric consultation is always available to you by calling these numbers.  
The doctors participating in this research study are also responsible for your clinical care.    
 If you have any questions about your rights as a research participant or any complaints, 
you may call the NYSPI-IRB Main Office at (646) 774-7155 during regular office hours.  
  
You will be given a copy of the signed Consent Form to keep.   
  
 
 
 
 


09/30/2016 IRB #6856   
  
  
  
Sponsor: Forest Laboratories   
Principal Investigator: Franklin Schneier, M.D  
  
  
  
10  
STATEMENT OF CONSENT  
I voluntarily agree to participate in the research study described above.    
  
NAME                                                      (print)  
  
Date________________ Signature ________________________________                                    
  
  
  
   
  
  
  
Study Participant  
I have discussed the proposed research with the patient, and in my opinion, this patient 
understands the benefits, risks and alternatives (including non-participation) and is 
capable of freely consenting to participate in this research.  
  
NAME                                                      (print)  
  
Date                               Signature________________________________                                       
                        
  
  
  
  
Study Physician  
  


Form #PP2: HIPAA Authorization for Research ϰ.ϭϰ.1ϰ 
New York State Psychiatric Institute (NYSPI) 
Authorization to Use or Disclose Health Information during a Research Study 
Protocol Number: 
Principal Investigator: 
Name of Study: 
Before researchers can use or share any identifiable health information (“Health Information”) about you as part of the 
above study (the “Research”), the New York State Psychiatric Institute (NYSPI) is required to obtain your authorization. You agree 
to allow the following individuals and entities to use and disclose Health Information about youas described below: 
x
New York State Psychiatric Institute (NYSPI), your doctors and other health care providers, if any, and
x
The Principal Investigator and his/her staff (together “Researchers”).   Researchers may include staff of NYSPI, the New York
State Office of Mental Health (OMH), Research Foundation for Mental Hygiene, Inc. (RFMH), and Columbia University (CU),
provided such staff is a part of the study, and
x
WƌŽǀŝĚĞƌƐŽĨƐĞƌǀŝĐĞƐĨŽƌƚŚĞZĞƐĞĂƌĐŚĂƚh͕Ez^W/ĂŶĚͬŽƌZ&D,͕ƐƵĐŚĂƐDZ/ŽƌWd͕ŽƌCentral Reference Laboratories 
;EKI), iĨ indicated in the consent form.
1.
The Health Information that may be used andͬŽƌ disclosed for this Research includes:
All information collected during the Research as told to you in the Informed Consent Form.   
Health Information in your clinical research record which includes the results of physical exams, medical and 
psychiatric history, laboratory or diagnostic tests, or Health Information relating to a particular condition that is related  to 
the Research. 
Additional information may include: 
2.
The Health Information listed above may be disclosed to:
Researchers and their staff at the following organizations involved with this Research: 
The Sponsor of the Research, 
and its agents and contractors (together, “Sponsor”); and  
Representatives of regulatory and government agencies, institutional review boards, representatives of the Researchers 
and their institutions to the level needed to carry out their responsibilities related to the conduct of the research.   
Private laboratories and other persons and organizations that analyze your health information in connection with 
this study 
Other (family members or significant others, study buddies, outside agencies etc.) Specify: 
3.
By giving permission to release your Health Information as described above, you understand that your Health
Information may be disclosed to individuals or entities which are not required to comply with the federal and state privacy laws
which govern the use and disclosure of personal Health Information by NYSPI.   This means that once your Health
6856
Franklin Schneier, MD
Vilazodone for Separation Anxiety Disorder in Adults
✔
✔
✔
New York State Psychiatric Institute
✔
Forest Labs
✔


Form #PP2: HIPAA Authorization for Research ϰ.ϭ.1ϰ 
Information has been disclosed to a third party which does not have to follow these laws (e.g., a drug company or the Sponsor 
of the Research), it may no longer be protected under the HIPAA or NYS Mental Hygiene Law requirements but is subject to the 
terms of the consent form and may be subject to other state or federal privacy laws or regulations.  
4.
Please note that:
x
You do not have to sign this Authorization form, but if you do not, youŵĂǇ not be able to participate in the study or
receive study related care.  You may change your mind at any time and for any reason. If you do so, you may no
longer be allowed to participate in the study.  If you withdraw this Authorization the research staff and the Sponsor, if this
is sponsored research, may still use or disclose Health Information containing identifying information they already have
collected about you as needed to maintain the reliability of the research.  Any request to withdraw this Authorization
must be made in writing to (enter name and contact information below):
x
While the Research is going on, you may not be allowed to review the Health Information in your clinical research
record that has been created or collected by NYSPI.   When this research has been completed you may be allowed to see
this information.  If it is needed for your care, your Health Information will be given to you or your Doctor.
5.
This Authorization does not have an end date.
6.
You will be given a copy of this form after you have signed it.
I agree to the use and disclosure of Health Information about me as described above: 
__________________________________________                _____________________ 
Signature of ParƚŝĐŝƉĂŶƚ/ Legal Representative    
Date 
______________________________________ 
Printed Name of ParƚŝĐŝƉĂŶƚ 
______________________________________ 
ZĞůĂƚŝŽŶƐŚŝƉŽĨ>ĞŐĂůZĞƉƌĞƐĞŶƚĂƚŝǀĞƚŽWĂƌƚŝĐŝƉĂŶƚ;ŝĨĂƉƉůŝĐĂďůĞͿ 
We also ask you or your legal representative to initial the statements below: 
I have received a copy of the NYSPI/OMH Notice of Privacy Practices. 
Franklin Schneier MD, New York State Psychiatric
Institute, Unit 69, 1051 Riverside Drive, New York, NY 10032


 
 
         Adult Separation Anxiety Study 
 
Are you anxious when separated from your child? 
Are you constantly contacting your child? 
Worry a lot about harm coming to your child? 
Do you worry excessively when your child travels alone? 
Do others say you are overprotective?  
Avoid activities that involve separation from your child? 
Fear being alone? 
Are these symptoms interfering with your life? 
 
 
 
 
If you are age 18-60, you may be eligible to participate in a research study of 
medication for treatment of Separation Anxiety Disorder in adults. Eligible 
persons will receive payment for their participation. For more information please 
contact Rob at (646) 774-8113 or valdovi@nyspi.columbia.edu. All calls are 
strictly confidential.   
 
    *Free Evaluation 
 
 
Anxiety Disorders Clinic 
New York State Psychiatric Institute/RFMH 
 
 
 
 
 
 
 
 
646-774-8113 
Separation Anxiety Study 
646-774-8113 
Separation Anxiety Study 
646-774-8113 
Separation Anxiety Study 
646-774-8113 
Separation Anxiety Study 
646-774-8113 
Separation Anxiety Study 
646-774-8113 
Separation Anxiety Study 
646-774-8113 
Separation Anxiety Study 
646-774-8113 
Separation Anxiety Study 
646-774-8113 
Separation Anxiety Study 
646-774-8113 
Separation Anxiety Study 
646-774-8113 
Separation Anxiety Study 
646-774-8113 
Separation Anxiety Study 
646-774-8113 
Separation Anxiety Study 
 

SAP_000.pdf: 
Data Analysis Plan for IRB #6856:  Vilazodone in Separation Anxiety Disorder 
 
Aggregate statistics for demographic and clinical characteristics of the two groups were 
calculated and compared using chi-square tests and t-tests, as appropriate. All quantitative post-
randomization outcomes were graphed and their distribution assessed for outlier values. 
To compare outcomes in the two groups, mixed effect logistic regression was used for the 
categorical outcomes and mixed effect regression models for quantitative outcomes, with 
subject-specific random effects and a first order auto-correlation structure for observations 
within the same individual. Time was included in the model as an additive factor (due to 
relatively low sample size, we did not test for differential time effect through interaction with 
group).