Conditions: Body Dysmorphic Disorders
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 12
Healthy volunteers: no

Brief summary:
In this pilot study 12 adult outpatients with body dysmorphic disorder that has not responded to at least one adequate trial of a serotonin reuptake inhibitor will be treated openly with a single oral dose of psilocybin. Followup visits to monitor safety and clinical outcome will be conducted over a 3 month period.

Detailed description:
In this pilot study, up to 12 adult outpatients with body dysmorphic disorder that has not responded to at least one adequate trial of a serotonin reuptake inhibitor will be treated openly with a single oral dose of psilocybin. Procedures will follow those previously established in depression studies of psilocybin. Patients will receive intensive preparation and support from two therapists, including 8-9 hours accompanying the patient on the day of medication administration in the Biological Studies Unit of New York State Psychiatric Institute. Followup visits to monitor safety and clinical outcome will be conducted at day 1, week1, and months 1,2, and 3 post-administration. Resting state function magnetic resonance imaging will be conducted prior to and one day after psilocybin administration to assess the effect of medication on brain circuits.

Arms:
arm 1: A single dose of Psilocybin 25mg p.o.

Interventions: intervention 1: Psilocybin
Intervention descriptions: intervention 1: A single dose of psilocybin 25 mg will be administered orally in the Biological Studies Unit of New York State Psychiatric Institute

Protocol document:
Prot_SAP_000.pdf: 
  
Study Protocol and Statistical Analysis Plan 


Protocol Summary Form
7950
Schneier, Franklin
1
Protocol Title:
Safety and Efficacy of Psilocybin for Body 
Dysmorphic Disorder
Protocol Number:
7950
First Approval:
02/27/2020
Expiration Date:
02/09/2024
Version Date:
01/10/2023
Research Area:  
Anxiety, Mood, Eating & Related Disorders
Division:  
Anxiety/PTSD/OCD
Contact Principal Investigator:
Franklin Schneier, MD
Email: franklin.schneier@nyspi.columbia.edu
Telephone: 646-774-8041
Co-Investigator(s):
David Hellerstein, MD
Research Chief:
Helen Simpson, MD
Cover Sheet
Choose ONE option from the following that is applicable to your study
If you are creating a new protocol, select "I am submitting a new protocol." As 5 Year Renewals are 
no longer required, this option remains for historical purposes.
I am submitting an annual continuation without modifications 
Department & Unaffiliated Personnel
Department
What Department does the PI belong to?
anxiety-mood-eating and related disorders
Within the 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.
Consultant Jamie Feusner, MD; University of Toronto


Protocol Summary Form
7950
Schneier, Franklin
2
Application for Continuation of Research
Status
Current Status of Study: 
All research interventions were completed. Only data analysis 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.
The study has concluded and is in the data analysis stage. Recruitment is closed and subject follow-ups have 
been completed. A total of 12 participants were enrolled in the study with 5 participants enrolling in the past 
year. None of the participants were withdrawn from the study or discontinued. There are no Serious Adverse 
Events to report. 
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? 
Yes
Certificate expiration date (mm/dd/yyyy) 
12/13/2023
Overall Progress


Protocol Summary Form
7950
Schneier, Franklin
3
Approved sample size
12
Total number of participants enrolled to date
12
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? 
No
Comments / additional information 
Sample Demographics
Select the # of samples applicable
Fair
Specify population
White Participants
Total number of participants enrolled from this population to date 
8
Specify population #2
Asian Participants
Total number of participants enrolled from this population to date 
3
Specify population #3
Other
Total number of participants enrolled from this population to date 
1
Specify population #4
Female
Total number of participants enrolled from this population to date 
8
Specify population #5
Male
Total number of participants enrolled from this population to date 
4
Gender, Racial and Ethnic Breakdown 
Gender Breakdown 8 female participants 4 male participants Racial Breakdown 8 White participants 3 
Asian Participants 1 participant who identified as other Ethnic Breakdown 1 participant who identified as 
Hispanic/Latino 11 participants who did not identify as Hispanic/Latino
Summary of Current Year's Enrollment and Drop-out 
Number of participants who signed consent in the past year
5


Protocol Summary Form
7950
Schneier, Franklin

Number of participants currently enrolled
0
Did the investigator withdraw participants from the study? 
No
Did participants decide to discontinue study involvement? 
No
3URFHGXUHV
To create the protocol summary form, first indicate if this research will include any of the following 
procedures 
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Indicate which of the following populations will be included in this research
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Protocol Summary Form
            
Rev. 10 – 11/08/2022
1
5HVHDUFK6XSSRUW)XQGLQJ
This section is to describe the funding sources for your protocol.
If an internal account is to be used, please describe.  
The internal account is  
 RFMH 
 CU
If the project is using, or planning to use, external funding, provide the details for each external funding 
source.
Compass Pathways
Principal Investigator on grant/contract
Franklin Schneier
Status of Grant (select one)
is currently funded
Source of Funding (select one)
Industry 
Institute / Agency
N/A
Grant Name
Safety and Efficacy of Psilocybin for Body 
Dysmorphic Disorder
Grant Number
N/A
Sponsor
Compass Pathways
Is this research initiated by the investigator?
Yes
 Site description (select one)
Single Site
Business Office (select one)
RFMH 
If the grant/contract includes a subcontract, please 
describe.  (To / From, Name of institution(s). Be 
sure to specify To or From)
N/A


Protocol Summary Form
            
Rev. 10 – 11/08/2022
2
6WXG\/RFDWLRQ
Indicate if the research is/will be conducted at any of the following:
  NYSPI
  Washington Heights Community Service
  Other Columbia University Medical Center Facilities
This Protocol describes research conducted by the PI at other facilities/locations:
  Office Of Mental Health Facilities
 Binghamton Psychiatric Center
  Bronx Children’s Psychiatric Center
  Bronx Psychiatric Center
  Brooklyn children’s Psychiatric Center
  Buffalo Psychiatric Center
  Capital District Psychiatric Center
  Central New York Psychiatric Center
  Creedmoor Psychiatric Center
  Elmira Psychiatric Center
  Greater Binghamton Health Center
  Hudson River Psychiatric Center
  Hutchings Psychiatric Center
  Kingsboro Psychiatric Center
  Kirby Forensic Psychiatric Center
  Manhattan Psychiatric Center
  Middletown Psychiatric Center
  Mid-Hudson Psychiatric Center
  Mohawk Valley Psychiatric Center
  Nathan S. Kline Institute
  Pilgrim Psychiatric Center
  Queens Children’s Psychiatric Center
  Rochester Psychiatric Center
  Rockland Children’s Psyciatric Center
  Rockland Psychiatric Center
  Sagamore Children’s Pyschiatric Center
  St. Lawrence Psychiatric Center
  South Beach Psychiatric Center
  Western NY Children’s Psychiatric Center
Or type in location(s)..


Protocol Summary Form
            
Rev. 10 – 11/08/2022
3
Click or tap here to enter text.
  Hospitals, clinics and other healthcare facilities
  Bridge Plaza Medical Center
  Harlem Hospital
  St. Luke’s-Roosevelt Hospital Center
  Mount Sinai Medical Center
  Weill Cornell Medical Center
Or type in location(s)..
Click or tap here to enter text.
  Schools/Educational Institutions
Type in location(s)..
Click or tap here to enter text.
  Prison System(includes Parole)
Type in location(s)..
Click or tap here to enter text.
  International Sites
Type in location(s)..
Click or tap here to enter text.
  Other Facilities
Type in location(s)..
Click or tap here to enter text.
  Community Sources
Type in location(s)..


Protocol Summary Form
            
Rev. 10 – 11/08/2022
4
Click or tap here to enter text.
/D\6XPPDU\RI3URSRVHG5HVHDUFK
This section is intended to provide a basic overview of the study including a description of its purpose, study procedures, 
and subject population.  The summary should provide a concise overview of the study for non-scientific and scientific 
members of the IRB.  Please avoid medical or technical terminology.  In general, the abstract of a grant does not provide 
a suitable lay summary.
Body dysmorphic disorder is a common condition characterized by symptoms of "imagined ugliness" with 
debilitating distress, checking and avoidance behaviors, and seeking unnecessary cosmetic medical 
procedures. Serotonin reuptake inhibitor medications and cognitive behavioral therapy helps some patients, 
but many do not benefit from existing treatments, and no medications are FDA-approved for this indication. 
Psilocybin is under development as a treatment of several psychiatric disorders, with placebo-controlled trial 
evidence of safety and prolonged efficacy for major depression when administered as a single dose with 
intensive support by a therapist on the day of administration. A single case report in body dysmorphic disorder 
suggests psilocybin might also have efficacy for this disorder.
In this proposed pilot study, up to 12 adults with body dysmorphic disorder that has not responded to at least 
one adequate trial of a serotonin reuptake inhibitor will be treated openly with a single oral dose of psilocybin. 
Procedures will follow those previously established in depression studies of psilocybin. Patients will receive 
intensive preparation and support from two therapists, including 8-9 hours accompanying the patient on the 
day of medication administration in the Biological Studies Unit. Follow-up visits to monitor safety and clinical 
outcome will be conducted at day 1, week1, and months 1, 2, and 3 post-administration. Resting state MRI will 
be conducted prior to and one day after psilocybin administration to assess the effect of medication on brain 
circuits.
%DFNJURXQG6LJQLILFDQFHDQG5DWLRQDOH
In this section, provide a brief summary of the status quo of the relevant work field and how the proposed study will 
advance knowledge. Specifically, identify the gaps in knowledge that your project is intended to fill. If no gaps exist that 
are obviously and directly related to your project, explain how your proposed research will contribute to the overall 
understanding of your field. Describe potential impacts of your project within your field of study and in a broader context. 
Provide a critical evaluation of existing knowledge. The literature review does not have to be exhaustive. 
Significance and Rationale


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5
Body dysmorphic disorder (BDD) is a debilitating psychiatric disorder in which individuals are preoccupied with 
perceived defects of their appearance that are not noticeable or appear slight to others, causing significant 
distress and functional impairment (Phillips 2005). Compulsive checking may occur, and sufferers may seek 
out unnecessary or risky cosmetic procedures. Most common concerns in BDD involve skin, hair, and nose. 
BDD has a high prevalence in the general population of 1.7%-2.9% (Buhlman et al., 2010), but it is under-
studied. To date, there have only been controlled clinical trials to evaluate a single medication class – 
serotonin reuptake inhibitors (Phillips et al 2002, 2006; Hollander et al 1999) – and a single psychotherapy 
modality – cognitive-behavioral therapy (Wilhelm et al 2014). Although these treatments can be effective in 
many, they typically result in only partial symptom improvement and some individuals do not respond to 
either. There is a need for new intervention approaches.
The rationale for considering psilocybin as a potential treatment for BDD includes a case report (Hanes 2003), 
in which unsupervised use of psilocybin resulted in symptomatic improvement, as well as evidence for 
psilocybin efficacy in conditions that frequently co-occur or overlap with BDD, such as obsessive-compulsive 
disorder (Moreno et al, 2006) and major depressive disorder. The first step in further evaluation of the efficacy 
and safety of psilocybin for BDD is this proposed open trial, utilizing methods established in prior controlled 
trials of psilocybin for other disorders.
Psilocybin Background (see Studerus, et al., 2011, for a useful review)
"Magic mushrooms" have been used ceremonially and recreationally for thousands of years. psilocybin
produces an altered state of consciousness (ASC) similar to LSD, characterized by marked alterations in
perception, mood, and thought, including changes in the experience of time, space, perceptual 
hypersensitivity, illusions, and pseudohallucinations (i.e. hallucinations with intact reality testing and insight) 
intensification of affective responses, enhanced ability for introspection, regression to primitive and childlike 
thinking, and activation of vivid memory traces with pronounced emotional undertones (Fischer, 1971; Geyer 
and Vollenweider, 2008; Isbell, 1959; Leuner, 1962; Nichols and Chemel, 2006; Rümmele and Gnirss, 1961; 
Wolbach et al., 1962). These effects are similar to those of LSD, except of shorter duration (4-6 hours instead 
of 8-12 hours) and psilocybin tended to produce less anxiety, fewer panic reactions and affective disturbances, 
and milder vegetative side effects than LSD.
     Direct pharmacologic effects of psilocybin appear to occur through stimulation (agonism) of various
serotonin receptors, including 5-HT2A, 5-HT2B, 5-HT2C and 5-HT1A. The 5-HT2A receptor seems
particularly important as many, but not all of psilocybin's effects are blocked by 5-HT2A receptor antagonists. 
Serotonergic hallucinogens such as psilocybin are considered relatively safe physiologically and do not 
produce dependence (Johnson et al., 2008; Leuner, 1981; Nichols, 2004).
     Studerus et al., 2011, summarized patient experience, physiologic effects and follow-up from 8 studies in
which 110 non-psychiatrically ill volunteers were given oral psilocybin 2-28 mg (depending on the study) or
placebo and followed for up to 16 months. They report the following dose-dependent symptoms (i.e., the 
higher the dose, the greater the effect):
- Positive experienced derealization


Protocol Summary Form
            
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6
- Positive experienced depersonalization
- Changed sense of time
- Positive mood
- Mania−like experience
- Anxious ego dissolution
- Negative experienced derealization
- Thought disorder
- Paranoia
- Loss of thought control
- Loss of body control
- Visionary restructuralization
- Elementary hall. & illusions
- Scenery hallucinations
- Synesthesiae (that is, stimulation of one sensory organ elicits a response from another sensory organ)
- Changed meaning of percepts
- Facilitated recollection
- Facilitated imagination
Psychological Adverse Events included:
- inactivation
- poor concentration
- tiredness
- dazed state
- introversion
- self-confidence (initially increased, later slightly decreased)
- heightened mood
- emotional excitation
- sensitivity
- slight increase in anger
- apprehension-anxiety
- depression
- dreaminess
Most of these adverse events returned to or toward baseline by 24 hours. The main exceptions were what 
they call "inactivation" and "tiredness" which remained nearly as high at 24 hours as at 3 hours. In addition, 
though closer to baseline, concentration remained decreased and dazed state and dreaminess were still 
increased at 24 hours. Griffith, et al. (2016) reports next day headache even with low dose psilocybin (1 mg or 
3 mg).


Protocol Summary Form
            
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7
Physical Adverse Events included (in parentheses are % experiencing at highest dose [.315 mg/kg = 22 mg in a 
70 kg person (154 pounds)]):
- fatigue (60%)
- exhaustion (22.5%)
- headache, head pressure or facial pain (37.5%)
- lack of energy (22.5%)
- excessive sleep requirement (15%)
- fast exhaustibility (17.5%)
- lack of appetite (17.5%)
- heavy or tired legs (12.5%)
- sleeplessness (5%)
- abdominal pain (7.5%)
- throat pain/irritation (7.5%)
- diarrhea (7.5%)
Long-term Negative Effects
We found a single case report of persistent psychological effects ("flashbacks") following psilocybin use 
(Espiard et al., 2005). Griffiths et al. (2016), followed 51 depressed and/or anxious terminal cancer patients for 
six months after they received 30 mg or 22 mg of psilocybin, reporting “all . . . adverse events resolved fully by 
the end of the session” except headache which persisted into the next day in two subjects, and "There were 
no cases of hallucinogen [sic] persisting perception disorder or prolonged psychosis.".
     While not definitive, given there are hundreds of reported dosings of psilocybin plus unknown numbers of
recreational usages, a single case report suggests continuing symptoms long past the drug's active effects are
likely rare. Several authors point out that early reports of continuing flashbacks following uncontrolled use of 
hallucinogens mainly refer to LSD, not psilocybin, and did not address whether other drugs were also used or 
whether pre-existing psychiatric conditions that will be excluded in the present study were also present. Also, 
such uses were rarely closely monitored by a facilitator as will occur in the present study.
     We are not aware of a study comparing facilitator to no facilitator. Intuitively, it makes sense that having
someone present who might assist the individual in making sense of their experience might mitigate against
it being as negative an experience as it might otherwise be, and we are not aware of reports of "flash-backs"
or other late negative effects in individuals who used psilocybin in the presence of a trained facilitator.
Addiction Potential
As psilocybin is a Schedule I drug (meant to mean "no currently accepted medical use and a high potential
for abuse") it is reasonable to have concern that study participants will become addicted to psilocybin. Our
understanding is there is no documented case of an individual becoming addicted to "magic mushrooms" or
psilocybin. In fact, individuals who have used either magic mushrooms or psilocybin repeatedly space
their use out as if their repeat use is less than several months after a prior use, they achieve only a fraction of
the earlier effect. This also argues against there being addiction potential for this compound.


Protocol Summary Form
            
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8
Rationale for the Psilocybin Doses use in this Study
Carhart-Harris, et al. (2016), suggested efficacy for depression with 10 and 25 mg and Griffiths, et al. (2016) 
found 20 and 30 mg doses to be effective for depression. Carhart-Harris reported 25 mg was well-tolerated 
with most adverse events being transient (1-3 hours) and mild, while Griffiths decreased their "high dose" 
from 30 mg to 22 mg because of poor tolerance of the 30 mg dose (vomiting); they reported 22 mg to be well 
tolerated with none of the adverse events requiring intervention beyond the supportive therapist. Both 
Carhart-Harris and Griffiths reported the only delayed (next day) adverse events were headaches lasting < 24 
hours. Personal communication with Carhart-Harris (2019), supported use of the 25 mg dose as optimal to 
maximize efficacy while minimizing risk of adverse events, based on his published studies and subsequent 
unpublished experience with psilocybin.
6SHFLILF$LPVDQG+\SRWKHVHV
Concisely state the objectives of the study and the hypothesis or primary research question(s) being examined.  There 
should be one hypothesis for every major study procedure or intervention.  For pilot studies, it is important not to 
overstate the study's objectives.  If there are no study hypotheses, describe broad study goals/aims.
1. Psilocybin will be acceptable to, and safe and well tolerated by, patients with BDD
2. Symptoms of BDD will improve after psilocybin administration, with persistent improvement over 3 
months of follow up
3. Resting state functional connectivity of the default mode network will increase from pre- to post-
treatment
'HVFULSWLRQRI6XEMHFW3RSXODWLRQ
In this section, you are to describe each subject population of the study.  The demographics of the population should 
reflect the gender and ethnic distribution of each population being studied.  Enter each subject population’s sample size, 
Gender, Racial, and Ethnic breakdown, and finally, describe each subject population.
Example:
Sample subject population:
Subject Population
Number of completers 
required to accomplish 
Projected number of 
subjects who will be 
enrolled to obtain required 
Age range of subject 
population


Protocol Summary Form
            
Rev. 10 – 11/08/2022
9
study aims
number of completers
Adults with BDD
12
12
18-55
Gender, Racial, and Ethnic Breakdown:
Gender Breakdown
4 male participants
8 female participants
Racial Breakdown
8 White participants
3 Asian participants
1 particopant who identified as “Other”
Ethnic Breakdown
11 Non-Hispanic/Latinx Participants
1 Hispanic/Latinx participant
Description of subject population:
Study sample will consist of adult participants between the ages of 18-55 with a diagnosis of Body Dysmorphic Disorder.
6XLFLGH5LVN0DQDJHPHQW3ODQ
This section will include all information regarding the Suicide Risk Management Plan.  
  The study is in data analysis and is not currently enrolling or recruiting participant so this would not be applicable to us.
5HFUXLWPHQW3URFHGXUHV
This section will include all information regarding your study’s recruitment process/procedures.  
Describe settings where recruitment will occur.  Virtual through websites RecruitMe.com, Craigslist and 
ClinicalTrials.gov. Recruitment has ended for this study.


Protocol Summary Form
            
Rev. 10 – 11/08/2022
10
How and by whom will subjects be approached and/or recruited?  Recruitment has closed for this study as of April 2022. 
When recruitment was open, sujects were recruited through the above websites and were approached by study 
coordinator, Gloria Gomez.
How will the study be advertised/publicized?  
Study will be advertised on the above websites, but recruitment has 
closed as of April 2022.
Attach any ads/recruitment materials requiring review at this time in the Uploads section.
Clinical Trials:
Please provide the NCT Registration Number for your Clinical Trial.  NCT04656301
YOU MUST REGISTER AT ClinicalTrials.gov IMMEDIATELY UPON RECEIPT OF IRB APPROVAL AND PRIOR TO 
ENROLLMENT OF THE FIRST SUBJECT.  YOU WILL BE PROVIDED WITH A NCT REGISTRATION NUMBER ON 
REGISTRATION.  PLEASE REVISE THIS SECTION OF THE PROTOCOL SUMMARY FORM TO INCLUDE THE NCT NUMBER 
AND RE-SUBMIT AS AN AMENDMENT TO THE IRB.
&RQFXUUHQW5HVHDUFK6WXGLHV
In this section, please identify if subjects in this study participate in or will be recruited from other studies.  
Describe where subjects are recruited from.   N/A
Describe the recruitment source for (Must provide IRB Number, PI and Title).  
N/A
,QFOXVLRQ([FOXVLRQ&ULWHULD
This section details your study sample(s) and addresses the requirement for risk minimization.
You may choose to divide your sample by population (healthy controls vs. patient population) or by procedure (subjects 
who will have an MRI vs. those who will not) and then define different sets of criteria for each.
For each sample, create or insert a table to describe detailed criteria for study inclusion and exclusion and the method 
you will use to ascertain each criterion. The method of ascertainment may describe tests, scales and instruments.  When 
relevant, indicate the level of training of the person who will make the assessment (e.g. clinical interview by a 
psychiatrist).
Inclusion/Exclusion Criteria need to be numbered and listed in outline form (see Table template below).
Adults (18-55) with a Diagnosis of Body Dysmorphic Disorder
CRITERION                                                         METHOD OF ASCERTAINMENT               


Protocol Summary Form
            
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11
Inclusion:
1.Age 18-55
Date of birth
2. DSM-5- body dysmorphic disorder, 
non-delusional subtype, for >6 months by 
history. Non-delusional subtype will be 
operationalized by Brown Assessment of 
Beliefs Scale (BABS) 6-item total <18 
(Phillips et al., 2006)
SCID -5 BDD module, BABS
3. At least moderate severity of BDD, 
operationalized by total score >24 on the 
Yale-Brown Obsessive-Compulsive Scale 
Modified for Body Dysmorphic Disorder 
(BDD-YBOCS), 
BDD-YBOCS
4. At least moderate overall severity, 
operationalized by score of at least 
moderate (4 or greater) on the CGI 
severity scale
CGI severity scale
5. History of intolerance of, or 
nonresponse to, a prior adequate trial of 
an SSRI (> 2 months of fluoxetine 20 
mg/day or equivalent), SNRI, or 
clomipramine
Psychiatric History
6. Currently in psychotherapy (other than 
CBT for BDD)
Psychiatric History
7. Able to provide informed consent
Psychiatric Assessment
Exclusion:
1. Current major depressive disorder of 
greater than moderate severity (17-item 
Hamilton Rating Scale for Depression 
total >20) 
Hamilton Rating Scale for Depression


Protocol Summary Form
            
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12
2. Current or past DSM-5 bipolar disorder, 
psychotic disorder, or borderline 
personality disorder. First degree relative 
with psychotic disorder or bipolar I 
disorder.
MINI, family history
3. DSM-5 alcohol or drug use disorder in 
the past 3 months, or positive result on 
urine drug screen for illicit substance of 
abuse (except that prior cannabis use 
subthreshold for abuse diagnosis will be 
permitted if discontinued >24 hours prior 
to dosing)
MINI, urine drug screen
4. Current clinically significant suicidality 
or a suicide attempt within the past year
Psychiatric Assessment, MINI, CSSR (items 3 
or 4 rated “yes” for active suicidal ideation) 
5. Need for inpatient or partial hospital 
treatment
Psychiatric Assessment
6. Mental retardation, dementia, brain 
damage, or other cognitive impairment 
that would interfere with participation 
Psychiatric Assessment and History
7. Body image concerns accounted for 
primarily by an eating disorder
Psychiatric Assessment
8. Body dysmorphic disorder criteria not 
met if weight concerns are excluded
Psychiatric Assessment


Protocol Summary Form
            
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13
9. Use of: investigational medication 
within past 3 months; depot 
antipsychotic within past 6 months; 
serotonergic medication within past 2 
weeks (6 weeks for fluoxetine). The ADC 
will not take subjects off medication for 
the purpose of entering this study.
Psychiatric and Medical History
10. Current cognitive-behavioral therapy 
(CBT) specific for BDD 
Psychiatric History
11. History of seizure disorder, other than 
febrile seizure in childhood 
Medical History
12. Presence of significant or unstable 
medical illness
Medical History, vital signs, EKG, blood and 
urine tests, physical examination
13. Females who are pregnant, 
breastfeeding, or sexually active and not 
willing to use adequate contraception 
Medical History, urine pregnancy test
14. Presence of any other conditions that 
would preclude safe administration of 
psilocybin based on clinical judgement of 
the PI and/or therapist. This includes but 
is not limited to any behaviors suggesting 
the participant will be unable to establish 
therapeutic alliance with the therapist
Psychiatric Assessment
15. Enrollment in any investigational drug 
or device study in past 30 days
Psychiatric History
16. Dissociative Disorder
Psychiatric Assessment


Protocol Summary Form
            
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14
17. Prior adverse effects from psilocybin
Psychiatric History
&RQVHQW3URFHGXUHV
Explain, in this section, the procedures for obtaining consent from study participants.
If the eligibility screening for this study is conducted under a different IRB protocol, enter the NYSPI IRB# 7094R
Currrently, the  study has concluded and is not enrolling or recruiting new participants. When the study was enrolling 
participants, consent was obtained by designated clinicians, Franklin Schneier, MD, Rapahel Campeas, MD, and Jose 
Arturo Sanchez Lacay, MD.  7950 participant consent forms were stored on our REDCap database. Consent procedures 
were also documented in EMR Progress Notes by clinicians. 
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The following sections are to be completed for the appropriate waiver/alteration of consent.  
:DLYHURI&RQVHQWIRUXVHRI3URWHFWHG+HDOWK,QIRUPDWLRQ3+,
What records do you wish to review? 
N/A
What information are you seeking access to?  
N/A
Describe your plan to protect identifiers from improper use and disclosure.  N/A
Describe your plan to destroy the identifiers as soon as possible, consistent with the conduct of the research, or 
provide a health or research justification for retaining the identifiers or explain how retention is required by law.  
N/A
Explain why the research could not be practicably carried out without the information (for which you are 
requesting access).  N/A
Explain why the research cannot be practicably carried out without the waiver.  N/A
Explain how/if subjects will be provided with additional pertinent information after participation.  
N/A
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Waiver of consent is requested for the following.  N/A
Explain why your research cannot be practicably carried out without the waiver or alteration.  
N/A


Protocol Summary Form
            
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15
Describe whether and how subjects will be provided with additional pertinent information after participation.  
N/A
:DLYHURI'RFXPHQWDWLRQRI&RQVHQW
Would the consent form signature be the only link between the subject’s identity and the research data? N/A
Is breach of confidentiality the main study risk? N/A
Is consent for this research procedure ordinarily not required outside of the research context?  Explain.  
N/A
Describe the study component(s) for which waiver of documentation is requested.  N/A
:DLYHURI3DUHQWDO&RQVHQW
Explain why parental/guardian consent is not a reasonable requirement to protect the minor participants in this 
study.  N/A
If parental consent is waived, describe a mechanism that will be substituted to provide appropriate protections 
for the subjects.  N/A
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In this section, please describe the procedures by which subject assent will be assessed and / or recorded.
N/A
3HUVRQV'HVLJQDWHGWR'LVFXVVDQG'RFXPHQW&RQVHQW
Please list all the names of persons designated to obtain consent / assent.  All persons must complete CITI training for 
NYSPI.  The PI affirms that each name listed has completed the appropriate training.
Franklin Schneier, MD
Raphael Campeas, MD
Jose Arturo Sanchez Lacay, MD


Protocol Summary Form
            
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16
,QGHSHQGHQW$VVHVVPHQWRI&DSDFLW\
This section is designated for those studies that have been identified where subjects May Lack capacity to consent.  
Describe the Methods/procedures for capacity assessment.  
N/A
If your study involves subjects who DO LACK capacity to consent, please justify.  N/A
Procedures for surrogate consent.  N/A
6WXG\3URFHGXUHV
Provide a clear, concise narrative of study procedures with special attention to the subjects' involvement.  Detail the 
overall study timeline and location of study procedures, list all interventions, assessments and interviews, estimate the 
duration of each procedure, provide dosing schedules, identify study personnel involved in each procedure, and provide 
credentials for relevant personnel.  If treatment is provided, specify the minimum credentials for providing that 
treatment. For complicated study designs, we strongly encourage attaching tables, flow-charts, and study algorithms.
I attest to follow the COVID-19 Safety Guideline for Columbia Psychiatry and NYSPI Re-Entry outlined in the 
NYSPI Director’s June 1, 2020 memo, which include but are not limited to:
•
Infection Control/PPE – Guidelines
•
Research participants will only come on-site if absolutely necessary for study procedures.
•
Clinical research teams will screen heir participants for COVID symptoms (night before and day of 
onsite visit, documenting this in the chart), and escort them in and out of the building.
•
COVID/COVID-like symptoms in participants will be reported to the IRB via PRISM as an SAE.
COVID testing: Depending on COVID conditions in the community, the participant and the two therapists 
scheduled to be with the participant during the psilocybin day may be tested at NY State Psychiatric Institute 
on the day before psilocybin dosing, to determine if any may currently be infected with the virus that causes 
COVID-19. The test involves collecting a sample by putting a cotton swab several inches into the nose. If the 
test shows that the participant or either therapist has COVID-19, your research treatment visit will be 
postponed.
Internet-based data collection or transmission will be conducted following HIPAA and NYSPI guidelines.
1. Visit 1 (Screening). A complete psychiatric and physical examination will be performed, including
Psychiatric, Medical and Social Histories, MINI Structured Psychiatric Interview, SCID-5 BDD module, Hamilton 
Rating Scale for Depression, Columbia Suicide Severity Rating Scale, and standard laboratory testing including 
EKG, urine for routine analysis, drugs of abuse and (if appropriate) pregnancy and blood for hematologies and 


Protocol Summary Form
            
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17
chemistries including thyroid function. A physical examination will be performed at the screening or between 
screening and Visit 2 (Day -1), with results obtained before psilocybin administration day. 
Additional screening will specifically assess eligibility for the MRI portion of the study with the self-rated 
PhenX Toolkit Hand Dominance Measure and MRI Metal Screening Questionnaire. Contraindications to MRI 
scanning are:
•
Paramagnetic metallic implants or devices
•
Contraindicating magnetic resonance imaging or any other non-removable paramagnetic metal in the 
body (e.g., pacemaker, paramagnetic metallic prosthesis, surgical clips, shrapnel, necessity for constant 
medicinal patch, some tattoos)
•
Being unable to tolerate the scanning procedures (i.e., severe obesity, claustrophobia)
Patients with contraindicated metal or left-handedness will not be offered MRI participation but will complete 
all other parts of the protocol. 
Additional visits (V1a, V1b) will be scheduled as needed to follow up on any lab abnormalities and for patient 
to establish relationship with study therapist. 
Participants will be invited to bring to the screening a companion (friend/family member) whom they would 
like to support them through the study. Such a companion will be informed of their potential role and will be 
asked to sign a “caregiver” consent form at the Screening Visit. Caregivers will receive information about the 
signs of worsening of depression and suicide risk and ways to contact the study team if necessary. The 
caregiver will complete a questionnaire at screening, Week 3 and Week 12. 
2. Visit 2 (Baseline, Day -1). Eligibility and willingness to participate will be reassessed. At this visit, the patient 
meets with the therapist who describes what the experience might be like and how the therapist will handle 
any difficulties the patient may have with the experience. MRI-eligible subjects will complete acquisition of 
resting state fMRI. Subjects will also complete an inverted face computer task in which they will view an image 
of a face and then will be shown an image of two faces (one matching and one non-matching morphed face) 
and asked to select the matching face as rapidly and accurately as possible. The matching and non-matching 
faces will be presented either upright or inverted, in various combinations. This task assesses global vs. local 
visual processing, and it has previously been shown to be abnormal in BDD (Feusner, 2010).
3. Visit 3 (Psilocybin Day, Day 0). The next day, a study psychiatrist again assesses eligibility; those eligible and 
agreeable receive their dose of psilocybin (25 mg) and spend the next eight hours (longer if needed) with the 
two therapists; when deemed appropriate, the patient is accompanied home either by a person of their 
choosing or a staff member. The patient will be reminded that they should not drive or drink alcohol at least 
until after the end of Visit 4 (next day). Vital signs are taken prior to their dose of psilocybin and prior to 
leaving the clinic and a study psychiatrist evaluates prior to their departure for whether their condition 
requires them not to leave. In the latter case, they will either remain in the Biological Studies Unit (BSU) until 


Protocol Summary Form
            
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18
cleared by a study psychiatrist or admitted to 5-South inpatient service if they require additional observation 
overnight.
Psychological Approaches to Anxiety
•
During Visit 2 and prior to ingestion of psilocybin during Visit 3, explain anxiety, even fear, may occur
•
During Visit 2, train patient in relaxation and breathing techniques that may alleviate anxiety
•
On Visit 3, shortly after psilocybin ingestion, remind subject of possible anxiety reaction and that 
therapist will walk them through it should it occur
•
During Visit 3, if patient reports excessive anxiety or fear, walk them through relaxation and breathing 
techniques taught during Visit 2
•
Encourage exploration of psilocybin experience
•
Call M.D. if fear is not alleviated by the above   
Rescue Medications
•
Anxiety: Lorazepam or alprazolam
•
Psychosis: Risperidone
•
Headache: Acetaminophen
•
Symptomatic elevation in BP: Beta-blocker (e.g., propranolol)
•
Nausea/vomiting: Ice chips
Hospitalization if needed
•
Given prior experience with psilocybin treatment, the need for inpatient hospitalization appears 
unlikely
•
In the event that patients require hospitalization they may be admitted to NYSPI 5-South unit.
•
Prior to psilocybin dosing Dr. Mary Bongiovi will be contacted (email or text 917-301-1584) to ascertain
•
whether backup 5S inpatient bed at NYSPI will be available. In event of lack of availability for such a 
bed on 5S after it has been offered (e.g., unanticipated issue on inpatient unit) the NYPH. Emergency 
Room will serve as backup.
4. Visit 4 (Post-Psilocybin Day 1). The patient returns to the anxiety clinic and reports any experiences since
leaving the clinic as well as having blood, urine, and EKG tests. MRI eligible patients will have another resting 
state fMRI session, The inverted face task will be repeated.
5. Visits 5-8 (Post-Psilocybin Weeks 1-3 and 12). The patient returns 1, 2, 3 and 12 one week later for
standard evaluation of psychiatric symptoms, functioning and AE's. These visits may be conducted by phone or 
secure video.
6. Telephone visits (Weeks 6 & 9). The patient is contacted by telephone 6- and 9-weeks post-psilocybin
for standard evaluation of psychiatric symptoms and AE's.


Protocol Summary Form
            
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7. Early Withdrawal Visit. Should the patient or study doctor decide to end the study visits prior to Week
12, if the patient agrees, all Visit 10 (Week 12) ratings including Independent Evaluation will be made.
Extra Visits
1. Extra visits (or in-person visits when phone visits are called for) will "kick in" if:
2. Patient reports on-going or intermittent negative effects, including but not limited to:
a. "Flash-backs"
b. Psychotic or quasi-psychotic (e.g., illusions, non-paranoid worries re. how others are viewing or 
treating them) experiences
3. Significant (e.g., > 25% increase in BDD-YBOCS) worsening from original severity.
4. Significant suicidality (e.g., patient reports suicidal thinking with any intent to act)
5. Physician's clinical judgment
Detailed Procedure for Staff Escort Home
In the event that it is deemed appropriate for a patient to return home following their psilocybin experience 
and said patient has not provided a responsible party to accompany him or her home, a staff member will 
accompany the individual from the BSU treatment room to the exterior door of their home. Transportation 
will be via a car service for which we will pay. The staff member will be instructed to contact the Anxiety 
Disorders Clinic doctor on call should he or she note grogginess or unsteady gait or other reasons to think the 
subject might have trouble being alone and the doctor will determine whether to have the staff member bring 
the subject back to NYSPI for further observation, erring on the side of further observation. Else, the staff 
member will allow the individual to enter their home and close the door, the staff member remaining outside 
and relieved of escort duties.
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At any visits in which patient reports clinical worsening, HamD, CSSR, and CGI will be repeated.
&ULWHULDIRU(DUO\'LVFRQWLQXDWLRQ
Define criteria that will be used to exit or drop subjects from the study and operationalize.  Indicate the time points when 
such criteria will be applied, and describe the rating instruments, parameters, and thresholds that will lead to a decision 


Protocol Summary Form
            
Rev. 10 – 11/08/2022
21
to terminate a subject's participation and the role of the person who will make these determinations. Studies which 
include a medication taper and discontinuation may be asked to include an independent medical monitor (an MD not on 
the study team) who will aid the study team in determining whether study discontinuation is needed.   In addition, 
explain procedures for managing subjects who are withdrawn from the protocol.
For treatment studies: To minimize risks to subjects, operationalized drop-out criteria should be defined so that subjects 
who worsen, or in some cases, fail to improve, are removed from the study and offered standard care.  The threshold for 
drop-out should consider the level of risk associated with non-improvement for the specific disorder, the availability of 
alternatives, and the typical required duration of treatment.  For example, emergence of suicidal intent, or psychosis, 
should prompt immediate clinical evaluation and withdrawal from the study.
1. Patient withdraws consent
2. Study personnel determines it is not in the patient's best interest to continue in the study. 
3. Clinical worsening
4. At each assessment participants will be evaluated for clinical worsening, and any participant who 
reports symptomatic worsening (CGI Change Score >4) will be further evaluated for need for urgent 
clinical treatment. Further evaluation will include the Hamilton Depression Scale, the Columbia 
Suicide Severity Rating Scale (C-SSRS), and the Clinical Global Impression Change Scale, but the 
ultimate decision to provide or refer to non-study treatment will be based on clinical judgement, 
with reasoning documented in the chart. 
5. Any participant who evidences need for non-study clinical treatment before psilocybin 
administration will be removed from the study and offered appropriate referrals, including 
transitional treatment in the Anxiety Disorders Clinic, or being walked to the emergency room if 
indicated. After psilocybin administration, clinical deterioration will be treated the same way, 
except that patients will be permitted to continue participation in remaining study assessments.
6. Potential pregnancy: Participants who prior to dosing have a positive pregnancy test or report 
suspecting pregnancy will be removed from the study.  Participants who after dosing have a 
positive pregnancy test will be excluded from the repeat MRI but will be allowed to continue in 
study assessments of symptoms.  They will be offered assistance with obstetrical follow-up
%ORRGDQGRWKHU%LRORJLFDO6DPSOHV
Describe how the sample will be used and indicate, when relevant, the amount of the sample.  The IRB wants to know 
that the sample is sufficient for the purposes of the study, but that sampling is limited to what is minimally necessary.  
If you’ve indicated that you intend to store a sample for future use, indicate where the sample will be stored, how long 
the sample will be stored, and to what purposes the sample will eventually be put.  Check the IRB website at 


Protocol Summary Form
            
Rev. 10 – 11/08/2022
22
https://irb.nyspi.org/investigators/guidance/genetic-research   for specific guidance and additional information about 
future use of DNA samples.
Blood will be drawn for routine testing of hematology (i.e., number, size and hemoglobin content of red blood 
cells and number and type of white blood cells) and chemistries (e.g., liver enzymes, electrolytes and
renal function) on each of three occasions: initial evaluation, 1day post psilocybin and three weeks post
psilocybin. Approximately 20 cc (= 4 teaspoons) of blood will be obtained on each occasion, or 60 cc = 3 
tablespoons total over 4-6 weeks. By contrast, 500 cc is taken on a single occasion when one donates blood.
$VVHVVPHQW,QVWUXPHQWV
List all assessment instruments, indicate who will administer them and their credentials/qualifications. Provide an 
estimate the duration of each measure.  The IRB wants to know that assessments instruments are appropriate measures 
for the purposes of the study and are no more burdensome than necessary.  The IRB will consider the burden of 
assessment instruments (in terms of time, sensitivity of material, etc.) in the risk/benefit analysis.  Please attach copies or 
otherwise provide all non-standard instruments.
•
5D-ASC – The Five Dimension Altered States of Consciousness Questionnaire measures the acute drug 
effects in terms of various ways of determining state of consciousness. 10 min.
•
BDD-YBOCS – The Yale-Brown Obsessive-Compulsive Scale Modified for BDD is a standard clinician-
rated measure of BDD symptom severity. 10 min.
•
BDD-REBUS-Q – 2-item questionnaire rating certainty of negative beliefs about self and appearance. 1 
min.
•
BABS – The Brown Assessment of Beliefs Scale is a clinician-rated scale assessing the intensity of body 
image belief in BDD. 10 min.
•
CGI Clinical Global Impression Scales, Severity and Change – global clinician-rated measures of 
symptom severity and Change 5 min.
•
CSSR – Columbia Suicide Severity Scale 10 min.
•
EBI – The Emotional Breakthrough Inventory is an 8-item brief measure intended to index the degree 
to which an individual experiences his/her emotion during a psilocybin session. It is a visual analogue 
style scale,  typically with units from 0 to 100. 5 min
•
QLESQ – The Quality-of-Life Enjoyment and Satisfaction Questionnaire is a self-rated measure. 5 min.
•
HAM-D-17 – The 17-item Hamilton Rating Scale for Depression measures the degree of symptom 
severity in depressed patients.
•
Liebowitz Social Anxiety Scale – 24 item scale assessing fear and avoidance of social anxiety 5 min
•
MRI Metal Screening Questionnaire - self-rated 5 min.
•
MINI - the Mini International Neuropsychiatric Interview, Version 7.0.2, is a standardized, semi-
structured interview that produces DSM-5 diagnoses. It is similar to the SCID. 30 min
•
PANAS - Positive and Negative Affect Schedule measures the acute emotional drug effects.5 min


Protocol Summary Form
            
Rev. 10 – 11/08/2022
23
•
PhenX Toolkit Hand Dominance Measure – self rated form 5 min.
•
Psychological Insight Scale – 7 question assess changes in insight on a visual analogue scale. 5 min
•
Qualitative Interview 
•
SDS – The Sheehan Disability Scale is a patient-reported outcome measure used to assess functional  
•
impairment and associated disability. 5 min.
•
Somatomap 2D (Ralph-Nearman et al. 2019) – A HIPAA-compliant web-based self-assessment tool for 
measuring body image perception. It displays an androgynous manikin; the user is asked to imagine it 
as their own body and draw directly upon it to outline an area of bodily concern. They then provide 
emotion ratings for each area of concern. Somatomap was built on Chorus, a HIPAA (Health Insurance 
Portability and Accountability Act)-compliant visual development platform. Chorus is a hosted service 
provided through the University of California Los Angeles (Areivan et al., 2018). 15 min
•
Sleep Questionnaire – 2 items assessing sleep quantity and quality.
•
Dysmorphic Concerns Questionnaire (Oosthuizen et al., 1998) – A 7-item self-rated scale assessing 
dysmorphic beliefs.
6HFWLRQVWREHFRPSOHWHGIRUVWXGLHVXVLQJ,1','('UXJVDQG'HYLFHV
Prior to the submission of any study involving a faculty held IND or IDE being approved by the IRB, the IND/IDE holder is 
required to submit a form signed by the IND/IDE holder and PI.
Which are applicable to your study:  
 Drug   
 Device   
 Radiolabeled drug/compound
2II/DEHODQG,QYHVWLJDWLRQDO8VHRI'UXJV
Enter the information for all drugs to be used in this study:
Name of the drug
Manufacturer and other Information
Approval Status (select one)
IND application is pending
IND is approved
No IND is required
IND #
Who holds the IND (i.e., IND Sponsor). 
If other than PI/CU Investigator, type 
name of holder.


Protocol Summary Form
            
Rev. 10 – 11/08/2022
24
Which applies:
FDA has determined the IND is not required (provide 
correspondence)
FDA conditions are met (see “Rules”) – Explain
2II/DEHODQG,QYHVWLJDWLRQDO8VHRI'HYLFHV
Enter the information for all devices to be used in this study:
Name of the device
Manufacturer and other Information
Approval Status (select one)
IDE application is pending
IDE is approved
No IDE is required
IDE #
Who holds the IDE (i.e., IDE Sponsor). If 
other than PI/CU Investigator, type 
name of holder.
Is the device marketed?
Which applies:
FDA has determined that IDE is not required
FDA conditions are met (see “Rules”) – Explain
Device is “Non-significant risk” – Explain
2II/DEHODQG,QYHVWLJDWLRQDO8VHRI5DGLRODEHOHG'UXJV&RPSRXQGV
Enter the information for all radiolabeled drug/compounds to be used in this study:
Name of the radiolabeled 
drug/compound
N/A
Manufacturer and other Information
N/A


Protocol Summary Form
            
Rev. 10 – 11/08/2022
25
Approval Status (select one)
IND application is pending
IND is approved
RDRC approval is pending
RDRC is approved
No FDA/RDRC approval is required - Explain
IND #
N/A
Who holds the IND (i.e., IND Sponsor ). 
If other than PI/CU Investigator, type 
name of holder.
N/A
5HVHDUFK5HODWHG'HOD\WR7UHDWPHQW
Research involving participants who are in need of treatment invariably involves delay to care, and this delay is 
associated with risk.  Scheduling of procedures must be carefully organized to minimize delay.  Other delay must involve 
only that minimally necessary to accomplish the aims of the research while respecting subject well- being and safety. 
Describe the delay, by virtue of research participation in this study, before a participant can receive treatment of known 
efficacy or standard care routinely offered in the community.
Participants in the study will need to be free of SSRI medication for at least 2 weeks prior to psilocybin 
administration and for 3 weeks thereafter, so total delay to an established treatment will be 5 weeks. Patients 
who for clinical reasons need treatment intervention sooner will be offered established treatment. If patients 
need to restart SSRI’s prior to the psilocybin session, they will be excluded. If they restart after the session, the 
reason will be documented, and the patient will be followed until the end of study visit provided that 
informed consent is maintained.
&OLQLFDO7UHDWPHQW$OWHUQDWLYHV
Describe what other treatment or assessment options are available to subjects who do not participate in research.
There are no FDA-approved medications for BDD, but SSRIs and specialized BDD-specific CBT have been shown 
to be efficacious in controlled trials. 


Protocol Summary Form
            
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26
5LVNV'LVFRPIRUWV,QFRQYHQLHQFHV
"Risk" is a broad term used to convey the potential for harm, burden, and inconvenience related to research 
participation.  Use this section to provide a comprehensive description of foreseeable physical, psychological, social, 
interpersonal, and economic risks introduced by the research.  Include the source of the information.  Consider both the 
probability and magnitude of harm and its impact.  Describe the foreseeable harms associated with the research 
(untoward effects of a medication) and those related to delay to individualized treatment.  Include data from the 
literature, and local data, if available, on risk rates and subject experiences with research procedures. Describe 
procedures in place to minimize risk. In general, please create a numbered list of risks/categories of risk, and in general 
put the list in the order of significance or level of risk, the most significant risks should be listed first. 
1. BDD might not remit or may worsen
2. Psilocybin has not been extensively studied, so both short and especially long-term consequences of its 
use may not be known at present
3. Known psychological effects of psilocybin include:
a. Euphoric mood
b. Dissociative experience (i.e., feeling outside one's body or unreal, a distorted sense of time
c.
Hallucinations (which may persist for weeks after dosing)
d. Psychotic experience such as paranoia
e. Difficulty with cognition (e.g., trouble adding or solving puzzles)
f.
Disturbance in attention
g. Mood alteration
h. Inappropriate affect (e.g., crying when one is not sad or laughing when nothing odd occurred)
4. Known medical effects of psilocybin include:
a. clumsiness
b. feeling weak
c.
headache
d. hyperreflexia (e.g., the lower leg reacts too strongly when the knee tendon is tapped)
e. hyporeflexia (e.g., the lower leg under-reacts when the knee tendon is tapped)
f.
increased blood pressure
g. increased pupil size
h. rapid heart beat
i.
tremor
j.
vomiting
5. Discomfort of needle sticks and ECG
6. Time commitment to completing forms, and attending evaluation, treatment and follow-up sessions
7. Harm to an unborn or newborn child
8. MRI


Protocol Summary Form
            
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27
Describe procedures for minimizing risks:
1. BDD might not remit - standard medication treatment, such as with an SSRI will be instituted and 
patient will be referred for CBT or other therapy as clinically indicated.
2. Psilocybin has not been systematically studied, so both short and especially long-term consequences of 
its use may not be known at present - while unknown risks cannot be minimized, we will minimize the 
likelihood of such risks occurring unnoticed during the study period by asking re AE's at every post-
psilocybin visit and encouraging patients to call between visits should any untoward events occur, 
whether they think they may be related or not.
3. Known psychologic effects of psilocybin include:
a. Euphoric mood - the risk of feeling too good is it can result in rash behavior, as in mania. We 
anticipate that if euphoria occurs, it will happen on the psilocybin day when the therapist and 
others are present to monitor and talk the patient down from an overly euphoric mood. As 
overly euphoric mood is a characteristic of bipolar illness, so to minimize risk the study excludes 
patients with known bipolar disorder. 
b. Dissociative experience (i.e., feeling outside one's body or unreal, a distorted sense of time) – 
We anticipate that if the patient has a dissociative experience, it will occur on the psilocybin 
day when the therapist will be present to "talk them down" and other clinicians will also be 
readily available.
c.
Hallucinations - as with b)
d. Psychotic experience such as paranoia - as with b); our anticipation is psychotic experiences will 
spontaneously remit within hours of the subject receiving psilocybin. If not, the on-call 
psychiatrist can determine whether to give an antipsychotic medication.
e. Difficulty with cognition (e.g., trouble adding or solving puzzles) - again, this will occur on the 
psilocybin day and will be minimized by therapist support, and it is anticipated to dissipate by 
the time the patient goes home, or at least by the next day. 
f.
Disturbance in attention - this is also anticipated to mainly occur on the day the patient receives 
psilocybin, but its impact on functioning will be monitored out to Week 12 using the SDS.
g. Mood alteration – mood will be monitored using the HAM-D-17 and the PANAS
h. Impaired Psychomotor skills - this will be monitored by clinical observation and is expected to 
resolve during the treatment day.
i.
Inappropriate affect (e.g., crying when one is not sad or laughing when nothing odd occurred) – 
this will be monitored by clinical observation and the PANAS and dealt with as part of the 
therapist's interaction with the patient.
4. Known medical effects of psilocybin:
a. Clumsiness - a staff member will remain with patient at all times ready to prevent falls as 
needed (e.g., traveling to and from the bathroom)
b. Feeling weak - ditto
c.
Headache - standard headache remedies (i.e., NSAID's)


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d. Hyperreflexia - reassurance and waiting
e. Hyporeflexia – reassurance and waiting
f.
Elevated blood pressure - watchful waiting as to date, the blood pressure has not been 
documented to get to dangerous levels (i.e., systolic pressure may get to 160 mm Hg); as blood 
pressure rises typically last 1-3 hours, a short-acting blood pressure lowering medication such 
as nifedipine could be considered
g. Increased pupil size - keep in darkened room (this is the standard lighting in psilocybin rooms
h. Rapid heartbeat - watchful waiting as to date, fast heart rate has lasted 1-3 hours; propranolol 
could be used but to my knowledge no "rescue" med has been required to date.
i.
Tremor - this typically lasts 1-3 hours so should not require anything besides reassurance; if 
severe enough, do not allow hot liquids
j.
Vomiting - this is unusual and time limited; probably too short-lived for anti-emetic medication 
to help; could try ginger ale or ginger tea
5. Discomfort of repeated needle sticks and other procedures: experienced, trained phlebotomists will 
obtain blood
6. Time commitment to completing forms, and attending evaluation, treatment, and follow-up sessions - 
we will do everything we can to limit time spent; e.g., if patients must wait for their doctor, they will be 
instructed to complete their self-report forms
7. Psilocybin is not considered safe during pregnancy or breast-feeding, because such safety testing has 
not been done. Therefore, potential participants will be excluded if pregnant, breast feeding or 
planning to become pregnant during the next 3 months. A pregnancy test will be done at screening. 
Pregnancy tests will be repeated at least twice during the study (on the day prior to taking psilocybin, 
and on the day taking psilocybin). Participants will be cautioned that even if a pregnancy test is 
negative, they could still be pregnant, because these tests cannot detect very early pregnancies (that 
is, within the first few days). Participants will be excluded if they do not agree use an effective form of 
birth control before and throughout study participation. Methods of birth control considered to be 
effective include double barrier methods (condom plus spermicide, or diaphragm plus spermicide), 
birth control pills, birth control shots and intrauterine devices. Men who are sexually active will also be 
excluded if they do not agree to using adequate contraception. Female partners of men participating in 
this study should use one of the acceptable methods of contraception (contraception pills, intrauterine 
device, bilateral tubal occlusion).
8. To minimize the risk of MRI we will observe United States Food and Drug Administration (FDA) 
guidelines for magnet strength and exposure to radio waves. We will exclude people with magnetic 
metal in their body through careful review and checklist. Participants will be specifically warned about 
risks of a pacemaker or metal objects inside the body, as well as the need to remove all metal from 
their clothing and all metal objects from their pockets. Also, although there are no known risks to 
pregnancy, we will not scan someone who is pregnant, and women in childbearing years will take a 
pregnancy test just before each MRI scan.


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In addition, and not specific to any one of the above, a physician will always be available should the therapist 
become uncomfortable, whether with physical reactions (such as elevated blood pressure) or behavior (e.g., 
belligerence) or reported symptoms (reports of psychotic symptoms or suicidality). The therapist's training will 
be to err on the side of calling the physician unnecessarily rather than allowing the patient's condition to 
worsen further. While our read of others' experiences with similar doses of psilocybin is situations requiring 
medical interventions are highly unlikely, we recognize it is important to be prepared for such an eventuality. I 
have not seen articles documenting the need for rescue medication so can only make the generic suggestion 
that for difficult psychiatric symptoms, one might first consider a short acting benzodiazepine, such as 
lorazepam, and then an antipsychotic medication, such as quetiapine. Medical symptoms would be 
counteracted using appropriate medications, e.g., nifedipine for hypertension. As the half-life of psilocybin 
and its first metabolite are a few hours it is not surprising that the adverse effects of psilocybin typically last 1-
3 hours, so it is likely that should rescue medication be needed it would only require short acting drugs; 
adverse events that continue into the next day are reported as having been mild (e.g., Hasler et al., 1997) 
while the only reported late appearing (i.e., not present acutely following psilocybin dose) adverse event is 
mild-moderate headache lasting < 24 hours.
0HWKRGVWR3URWHFW&RQILGHQWLDOLW\
Describe the data management plan and the methods you will employ to protect subject privacy and the confidentiality 
of research data.  The section should detail how information will be collected, recorded, coded, stored, transmitted, and 
as applicable, shared with other investigators so as to minimize risks related to breach of confidentiality.  Confirm that 
identifiers are removed, to the extent possible, from research data, and explain if there are links between subject identity 
and research data, or if the data are anonymous.  Also, indicate where the data are stored, who is responsible for data 
safekeeping, and who has access to subject identity and codes, if any, which cross-link research data and subject identity.  
Confirm that identifiable data are not collected, stored, or transmitted by mail, fax, on removable drives, laptops, or via 
the internet without proper protections, e.g. encryption.
Confidentiality will be maintained by keeping physical data in locked file cabinets. Any electronic data,
including laboratory results will be communicated within strict HIPAA rules. Methods by which confidentiality 
is protected include HIPAA-compliant videoconferencing and web-based platforms. Any data sent to the 
company will include initials, gender, marital status, SES and education and date of birth only without 
additional potential identifying information. Should it become necessary for the treating psychiatrist to 
contact the subject’s primary physician to obtain copies of their medical records or release our records to 
other providers, explicit written agreement for such record transfers will be obtained from the patient. Any 
electronic data stored at the Anxiety Disorders Clinic will be kept behind the NYSPI firewall with access only to 
authorized personnel by individual password. We will be applying for a certificate of confidentiality.


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We will provide Compass with safety data from the Study, for storage by Compass on a central database. Such 
information shall be provided to Compass on a regular and on-going basis throughout the Study.  
Notwithstanding the foregoing, patients must be consented to have their data stored in this secure centralised 
database, maintained by Worldwide Clinical Trials (WCT). Only patients who consent to this process will have 
their personal data transferred. 
All types of adverse event will be promptly reported to Compass for use in the Compass/WCT safety database, 
they do however have different recording and reporting requirements, as set out below. 
For the purposes of reporting to the safety database, and subject to data protection requirements, we will 
promptly report to Compass all Serious Adverse Events (“SAEs”) regardless of the causal relationship to the 
Study Drug.  
Assessment of Seriousness 
For the purposes of the reporting of the adverse events to Compass, each adverse event will be assessed for 
its seriousness.  An SAE is any event that meets any of the following criteria:
•
Death
•
Life-threatening
•
Inpatient hospitalization or prolongation of existing hospitalization
•
Persistent or significant disability/incapacity
•
Congenital anomaly/birth defect in the offspring of a subject who received the study drug.
Other: Important medical events that may not result in death, be life-threatening, or require hospitalisation, 
may be considered an SAE when, based upon appropriate medical judgment, they may jeopardise the Subject 
and may require medical or surgical intervention to prevent one of the outcomes listed in this definition. 
Examples of such events are:
•
Intensive treatment in an emergency room or at home for allergic bronchospasm
•
Blood dyscrasias or convulsions that do not result in inpatient hospitalisation
•
Development of drug dependency or drug abuse
Adverse Events of Special Interest 
For the purposes of the safety database, an adverse event of special interest (“AESI”) is an adverse event 
(serious or non-serious) of scientific and medical concern specific to the study drug, for which ongoing 
monitoring by the Clinical Investigator is required. Such adverse events may require further investigation to 
characterise and understand them. 


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The following events will be reported as AESI:
•
Euphoric mood
•
Dissociative disorder
•
Hallucination
•
Psychotic disorder
•
Cognitive disorder
•
Disturbance in attention
•
Mood altered
•
Psychomotor skills impaired
•
Inappropriate affect
•
Overdose
•
Intentional product misuse
All AESIs will be followed until resolved or stable.
Reporting Adverse Events 
Each adverse event will be assessed to determine whether it should be classified as a SAE.  If the adverse 
event is considered serious, we will report this event in line with requirements of the study sponsor and the 
IRB. This may include completing a sponsor specific SAE reporting form, within 24 hours of learning about the 
event, regardless of causal relationship to the Study Drug. 
For the purposes of reporting to the safety database, these events will also be recorded on a specific Compass 
adverse event database CRF, within 24 hours of our becoming aware of them. This will also be the case for 
AESI. 
If we detect an SAE in a Subject after the last scheduled follow-up visit, and consider the SAE related or 
possibly related to the administration of the Study Drug, will report this to the sponsor. We will also report the 
event, on the Compass adverse event database CRF and send this in accordingly. 
We will report all other adverse events promptly to the Compass safety database after first becoming aware of 
such adverse event. These events will be reported and transferred on our Institution’s own study CRFs. 
All information about adverse events will be collected and once the relevant form is completed, it will be 
scanned and sent by email message or facsimile to WCT. The initial report should include the following 
information:
•
Event


Protocol Summary Form
            
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32
•
Study code
•
Reporter name and contact information
Site staff will complete the paper Compass AE Database CRF form and email it to the following address: 
drugsafety@worldwide.com
In cases where the email system is unavailable, site staff will send the SAE by fax to: +18663875539 (US) and 
+44 208 043 4813 (ROW).
Category of Adverse Event
Time Frame to Report to 
Compass/WCT Database 
How to Report to 
Compass/WCT Database 
Adverse Event (AE)
Timely Manner/ Before the 
end of the study
Submit site specific AE CRF to 
WCT
Serious Adverse Event (SAE)
Within 24 hours of becoming 
aware of event
Submit a copy of the 
Compass provided AE CRF to 
WCT
Adverse Events of Special 
Interest (AESI)
Within 24 hours of becoming 
aware of the event 
Submit a copy of the 
Compass provided AE CRF to 
WCT
Fig 1. Reporting requirements 
Due to the limited safety data that have been collected formally for the Study Drug, all SAEs that are 
considered to be related will also be unexpected and therefore classified as Serious, Unexpected, Suspected 
Adverse Reactions (SUSARs). Classification of an SAE as a SUSAR will be determined on a case by case basis by 
WCT. Once an unexpected event has occurred, it will become expected in the future. The IBD will be updated 
annually to reflect changes in expected adverse events.  
GDPR
As owners of the external safety database, Compass Pathways are the “data controller” for this aspect of the 
research. WCT and the research team will act as “data processors”.  
Subjects will have the following rights regarding accessing their data stored in this database: 
1. To request to review their data held in the safety database.


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2. To request for any inaccuracies to be corrected.
3. To raise objections to its content and to the continued processing of their data in this database.
4. To request to have their data removed from this database.
If any subject requests any of the above points regarding their safety data held in the safety database, we will 
notify Compass as soon as the request is made. Requests will be reviewed on a case-by-case basis and where 
Compass sees fit to action the request; they will work with us to resolve them as needed.
'LUHFW%HQHILWVWR6XEMHFWV
Describe only benefits to individual subjects that are likely to accrue during the study itself. Do not include subject 
compensation or treatment to be provided at the end of the study, as these do not figure into the IRB's risk/benefit 
considerations.  Do not describe diagnostic and evaluation components unless subjects receive clinical feedback. Do not 
describe the anticipated scientific benefits of the research.  Some studies offer no direct benefit to subjects.
There may be no direct benefit. The information we get from this study may help us treat people with BDD 
better in the future
&RPSHQVDWLRQDQGRU5HLPEXUVHPHQW
If compensation or reimbursement for expenses will be offered to subjects, please describe and indicate total amount 
and schedule of payment(s). If transportation is reimbursed, state if receipts are necessary for reimbursement.  Include 
justification for compensation amounts and indicate if there are bonus payments.
 $300 after completion of the pre-dosing visit, dosing visit, and the post dosing visit ($100 each visit).
$250 after completion after completion of 5 follow up visits. ($50 each visit)
Total compensation will be $550
3URWRFRO6SHFLILF3ODQV363V
All federally funded, more than minimal risk studies are required to include a Training Plan, an Internal 
Monitoring/Quality Assurancee Plan, and a Data Management Plan. Collectively, these plans are called the Protocol 
Specific Plans or PSPs. More information can be found on the IRB  website (irb.nyspi.org) regarding these plans and 
should be reviewed prior to submission. 


Protocol Summary Form
            
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34
7UDLQLQJ3ODQV
A training plan should describe, in detail, ALL training required for each member of the study team, frequency of 
the training, and location of the Training Log and training certificates. Elements of an effective training plan 
include: all sessions documented with an attendance list, all members of the study team listed on the Delegation 
of Authority log must be in compliance with the training plan and be trained for each study procedure they are 
authorized to perform, the training log is maintained by the Research Coordinator in the Regulatory Binder, and 
sample timepoints for the Training Log are before protocol initiation meeting, protocol initiation meeting, 
annual protocol meeting, and new staff training.   The study is in data analysis and is not currently enrolling or 
recruiting participant so this would not be applicable to us.
,QWHUQDO0RQLWRULQJ4XDOLW\$VVXUDQFH3ODQ
Please utilize the Quality Assurance Monitoring plan template on the NYSPI IRB website (irb.nyspi.org) and cut & 
paste to this section. A lead QA monitor will need to be designated and named in the study’s monitoring plan. 
Section A will describe the monitoring schedule and reporting. Section B will describe the data that will be 
reviewed on an ongoing basis.  The study is in data analysis and is not currently enrolling or recruiting 
participant so this would not be applicable to us.
'DWD0DQDJHPHQW3ODQ
The required elements of the Data Management Plan include: identification of the database platform (e.g., 
REDCap) and inclusion of an attestation that it is Part 11 compliant, identification of a qualified staff member 
who designs and maintains the database, design and implementation of data system training for all Principal 
Investigators & research coordinators & all protocol staff, and significant changes to the data management plan 
will be submitted as protocol amendments in PRISM.  
The study is in data analysis and is not currently 
enrolling or recruiting participant so this would not be applicable to us.
5HIHUHQFHV
Please limit references, preferably no more than twenty.
Buhlmann U, Glaesmer H, Mewes R, Fama JM, Wilhelm S, Brähler E, et al. Updates on the prevalence of body 
dysmorphic disorder: a population-based survey. Psychiatry Res. 2010 Jun 30;178(1):171–5.
Carhart-Harris RL, Bolstridge M, Rucker J, et al. Psilocybin with psychological support for treatmentresistant
depression: an open-label feasibility study. Lancet. 2016;3(7):619-627.
Dakwar E. The death and rebirth of hallucinogens. Drug and Alcohol Dependence. 2016;165:293–297.


Protocol Summary Form
            
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35
Feusner JD, Moller H, Altstein L, et al. Inverted face processing in body dysmorphic disorder. J Psychiatr Res. 
2010;44(15):1088–1094. 
Gouzoulis-Mayfrank E, Thelen B, Habermeyer E, et al. 1999b. Psychopathological, neuroendocrine and
autonomic effects of 3,4-methylenedioxyethylamphetamine (MDE), psilocybin and D-methamphetamine in
healthy volunteers. Results of an experimental double-blind placebo-controlled study. Psychopharmacology
(Berl). 1999b;142(1):41-50.
Gouzoulis-Mayfrank E, Thelen B, Habermeyer E, et al. 1999b. Psychopathological, neuroendocrine and
autonomic effects of 3,4-methylenedioxyethylamphetamine (MDE), psilocybin and D-methamphetamine in
healthy volunteers. Results of an experimental double-blind placebo-controlled study. Psychopharmacology
(Berl). 1999b;142(1):41-50.
Griffiths RR, Johnson MW, Richards WA, Richards BD, McCann U, Jesse R. Psilocybin occasioned
mystical-type experiences: immediate and persisting dose-related effects. Psychopharmacology (Berl).
2011;218(4):649-665.
Hanes, K. R. Serotonin, Psilocybin, and Body Dysmorphic Disorder. J. Clin. Psychopharmacol. (1996) 16:188-
189.
Hasler F, Grimberg U, Benz MA, Huber T, Vollenweider FX. Acute psychological and physiological effects
of psilocybin in healthy humans: a double-blind, placebo-controlled dose-effect study. Psychopharmacology
(Berl). 2004;172(2):145-156.
Hollander E, Allen A, Kwon J, Aronowitz B, Schmeidler J, Wong C, et al. Clomipramine vs Desipramine 
Crossover Trial in Body Dysmorphic Disorder: Selective Efficacy of a Serotonin Reuptake Inhibitor in Imagined 
Ugliness. Arch Gen Psychiatry. 1999 Nov 1;56(11):1033–9.
Moreno, F. A., Wiegand, C. B., Taitano, E. K. & Delgado, P. L. Safety, tolerability, and efficacy of
psilocybin in 9 patients with obsessive-compulsive disorder. J. Clin. Psychiatry (2006).
doi:10.4088/JCP.v67n1110
Nichols DE: Psychedelics. Psychopharm Rev 2016;68:264-355.
Oosthuizen P, Lambert T, Castle DJ: Dysmorphic concern: Prevalence and association with clinical variables. 
Australian and New Zealand Journal of Psychiatry 1998; 32:129-132
Phillips KA. The Broken Mirror: Understanding and Treating Body Dysmorphic Disorder. Oxford University 
Press; 2005. 412 p.


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36
Phillips KA, Albertini RS, Rasmussen SA. A Randomized Placebo-Controlled Trial of Fluoxetine in Body 
Dysmorphic Disorder. Arch Gen Psychiatry. 2002 Apr 1;59(4):381–8.
Phillips KA, Keshavian A, Dougherty DD, Stout RL, Menard W, Wilhelm S. Pharmacotherapy Relapse Prevention 
in Body Dysmorphic Disorder: A Double-Blind, Placebo-Controlled Trial. Am J Psychiatry. 2016 Sep 
1;173(9):887–95.
Phillips KA, Menard W, Pagano ME, Fay C, Stout RL. Delusional versus nondelusional body dysmorphic 
disorder: clinical features and course of illness.  J Psychiatr Res. 2006 Mar;40(2):95-104.
Ralph-Nearman C, Arevian AC, Puhl M, et al. A Novel Mobile Tool (Somatomap) to Assess Body Image 
Perception Pilot Tested With Fashion Models and Nonmodels: Cross-Sectional Study. JMIR Ment Health. 
2019;6(10):e14115. Published 2019 Oct 29.
Studerus E, Kometer M, Hasler F Vollenweider FX: Acute, subacute and long-term subjective effects of
psilocybin in healthy humans: a pooled analysis of experimental studies. J Psychopharm 2011;25(11):1434–
52.
Wilhelm S, Phillips KA, Didie E, Buhlmann U, Greenberg JL, Fama JM, et al. Modular cognitive-behavioral 
therapy for body dysmorphic disorder: a randomized controlled trial. Behav Ther. 2014 May;45(3):314–27.
  


Statistical Analysis Plan 
The primary efficacy measure was BDD symptom severity, as measured by the BDD-
YBOCS, a clinician-rated scale (total score range: 0-48, with higher scores indicating 
greater severity). Response to treatment has been defined and validated as > 30% 
decrease in total score, and partial-to-full remission as total score <16 (Fernandez de la 
Cruz et al. 2019).  
 
Statistical Analyses: For YBOCS and other repeated outcome measures, repeated 
measures ANOVAs with Greenhouse-Geiser corrections will be conducted across time 
points from baseline to week 12 using SPSS Version 23.0 (IBM SPSS Statistics for 
Windows, Version 23.0. Armonk, NY: IBM Corp), with post hoc pairwise Bonferroni-
corrected comparisons. For the HRSD a paired samples t-test will be performed to 
compare baseline to week 12 scores.