Clinical trial NCT00644358: A One Year Open Label Study Assessing the Safety and Tolerability of Vilazodone in Patients With Major Depressive Disorder (MDD)
Official title: A One Year Open Label Study Assessing the Safety and Tolerability of Vilazodone in Patients With Major Depressive Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Major Depressive Disorder
Lead sponsor: Forest Laboratories
Sponsor class: INDUSTRY
First posted: 2008-03-26
Enrollment: 616
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This open label 52-week clinical trial is designed to assess the safety and tolerability of vilazodone and to analyze genetic markers of response to vilazodone in adult patients diagnosed with MDD. This study will enroll approximately 600 patients.

Detailed description: Patients will be enrolled at approximately 40 US investigative sites and receive vilazodone for 52 weeks of open label treatment. Safety measurements will include adverse events, vital signs, laboratory, ophthalmologic exams, Changes in Sexual Function Questionnaire (CSFQ) scale and electrocardiogram (ECG) findings collected over the course of the treatment period. Effectiveness measurements will be done at baseline and each visit until week 52 or end-of-treatment. A deoxyribonucleic acid (DNA) sample will be collected for genetic analysis related to response to vilazodone.

Eligibility criteria: Inclusion Criteria:

* Males or females 18-70 years of age.
* Meets Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria for Major Depressive Disorder.
* Hamilton Depression Rating Scale (HAM-D) score ≥ 18 on the first 17 items of the 21-item HAM-D at Screening and Baseline Visits.
* Patients must have general ocular health.

Exclusion Criteria:

* Patients with a history of schizophrenia, schizoaffective disorder or bipolar I or II disorder (with a history of hypomanic or manic episodes).
* Patients who meet DSM-IV-TR criteria for substance abuse or dependence within 1 year of the Baseline visit.
* Patients who, in the Investigator's judgment, pose a serious suicidal or homicidal risk or have made a suicide attempt within 6 months prior to Screening Visit.
* Patients who are taking psychotropic drugs. Patients who have taken psychotropic drugs must have discontinued these prior to Screening Visit.
* Patients taking migraine medications with a serotonergic mechanism of action.
* Patients taking Cytochrome P450 3A4 (CYP3A4) inhibitors such as grapefruit juice, ketoconazole, diltiazem, and macrolide antibiotics.
* Patients with a known hypersensitivity to selective serotonin reuptake inhibitors (SSRIs) or 5-hydroxytryptamine 1a (5-HT1a) agonists.
* Patients previously treated with vilazodone.
* Patients taking Chantix or St. John's Wort.
* Presence of significant acute or chronic medical disorders by history or physical exam.
* Patients with a history of seizure disorders.
* Prior history of malignancy if patient has \<5 year survival OR completed treatment \<1 year prior to enrollment and is currently without evidence of recurrence.
* Skin cancers other than malignant melanoma will be permitted.
* Patients with evidence of other central nervous system disorders including psychosis, delirium, dementia and amnesic disorders.
* Patients with renal impairment or hepatic impairment.
* Patients who are not euthyroid.
* Patients with any serious medical or neurological disorder or condition that make it unlikely that the patient could complete one year of treatment or would otherwise preclude the administration of study medication.
* Female patients must not be pregnant, not lactating, and not planning to become pregnant during the time of study participation. All female patients who are not at least 1 year post menopausal or irreversibly surgically sterilized must be using adequate and reliable contraception throughout the trial.
* Patients with clinically significant ECG abnormalities which, as determined by the investigator, make it unlikely that the patient would complete one year of treatment or would otherwise preclude treatment with vilazodone.
* Patients having clinically significant abnormal laboratory findings.
* Patients with a positive drug screen.
* Patients who, in the opinion of the investigator, would be noncompliant with the visit schedule or study procedures.
* Patients that have taken an investigational drug or participated in an investigational drug trial within the past 30 days.

Primary outcomes:
measure: Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
timeFrame: From first dose of study medication and up to 30 days after the last dose of study medication (Up to 13 months)
Secondary outcomes:
measure: Change Form Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Score
timeFrame: Baseline and Weeks 1, 2, 3, 4, 6 ,8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52/Early Termination
measure: Change From Baseline in Clinical Global Impressions - Severity (CGI-S) Score
timeFrame: Baseline and Weeks 1, 2, 3, 4, 6 ,8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52/Early Termination
measure: Clinical Global Impression - Improvement (CGI-I) Score
timeFrame: Weeks 1, 2, 3, 4, 6 ,8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52/Early Termination
Other outcomes:
Locations:
city: Garden Grove
country: United States
facility: Collaborative Neuroscience Network, Inc.
state: California
city: San Diego
country: United States
facility: Affiliated Research Institute
state: California
city: Torrance
country: United States
facility: Collaborative Neuroscience Network, Inc
state: California
city: Upland
country: United States
facility: Pacific Clinical Research
state: California
city: Denver
country: United States
facility: Radiant Research
state: Colorado
city: Coral Springs
country: United States
facility: CNS Clinical Research Group
state: Florida
city: Fort Myers
country: United States
facility: Gulfcoast Clinical Research
state: Florida
city: Gainesville
country: United States
facility: Sarkis Clinical Trials
state: Florida
city: Jacksonville
country: United States
facility: Clinical Neuroscience Solutions, Inc
state: Florida
city: Lady Lake
country: United States
facility: Florida Clinical Research Center, LLC
state: Florida
city: Orlando
country: United States
facility: Clinical Neuroscience Solutions, PA
state: Florida
city: Tampa
country: United States
facility: Stedman Clinical Trials
state: Florida
city: Smyrna
country: United States
facility: Carman Research
state: Georgia
city: Chicago
country: United States
facility: Chicago Research Center
state: Illinois
city: Libertyville
country: United States
facility: Capstone Clinical Research
state: Illinois
city: Indianapolis
country: United States
facility: Davis Clinic
state: Indiana
city: Overland Park
country: United States
facility: Vince and Associates Clinical Research
state: Kansas
city: Rockville
country: United States
facility: Capital Clinical Research Associates
state: Maryland
city: Farmington
country: United States
facility: Summit Research Network
state: Michigan
city: Saint Louis
country: United States
facility: Radiant Research
state: Missouri
city: Las Vegas
country: United States
facility: Radiant Research
state: Nevada
city: Mount Kisco
country: United States
facility: Bioscience Research, LLC
state: New York
city: New York
country: United States
facility: Eastside Comprehensive Medical Center
state: New York
city: New York
country: United States
facility: The Medical Research Network, LLC
state: New York
city: Beachwood
country: United States
facility: North Coast Clinical Trials
state: Ohio
city: Cincinnati
country: United States
facility: Patient Priority Clinical Sites, LLC
state: Ohio
city: Middleburg Heights
country: United States
facility: North Star Medical Research, LLC
state: Ohio
city: Oklahoma City
country: United States
facility: IPS Research Company
state: Oklahoma
city: Bridgeville
country: United States
facility: Paramount Clinical Research
state: Pennsylvania
city: Colmar
country: United States
facility: Introspect of Buxmont
state: Pennsylvania
city: Media
country: United States
facility: Suburban Research Associates
state: Pennsylvania
city: Memphis
country: United States
facility: Clinical Neuroscience Solutions
state: Tennessee
city: Austin
country: United States
facility: FutureSearch Trials
state: Texas
city: Dallas
country: United States
facility: FutureSearch Trials
state: Texas
city: San Antonio
country: United States
facility: Croft Group Research Center
state: Texas
city: Woodstock
country: United States
facility: Neuropsychiatric Associates
state: Vermont
city: Herndon
country: United States
facility: Neuroscience, Inc.
state: Virginia
city: Midlothian
country: United States
facility: Dominion Clinical Research
state: Virginia
Study officials:
affiliation: Forest Laboratories
name: Carol R Reed, MD
role: STUDY_DIRECTOR
References:
citation: Jain R, Chen D, Edwards J, Mathews M. Early and sustained improvement with vilazodone in adult patients with major depressive disorder: post hoc analyses of two phase III trials. Curr Med Res Opin. 2014 Feb;30(2):263-70. doi: 10.1185/03007995.2013.855188. Epub 2013 Oct 31.
citation: Clayton AH, Kennedy SH, Edwards JB, Gallipoli S, Reed CR. The effect of vilazodone on sexual function during the treatment of major depressive disorder. J Sex Med. 2013 Oct;10(10):2465-76. doi: 10.1111/jsm.12004. Epub 2012 Dec 6.
citation: Reed CR, Kajdasz DK, Whalen H, Athanasiou MC, Gallipoli S, Thase ME. The efficacy profile of vilazodone, a novel antidepressant for the treatment of major depressive disorder. Curr Med Res Opin. 2012 Jan;28(1):27-39. doi: 10.1185/03007995.2011.628303. Epub 2011 Nov 23.
citation: Robinson DS, Kajdasz DK, Gallipoli S, Whalen H, Wamil A, Reed CR. A 1-year, open-label study assessing the safety and tolerability of vilazodone in patients with major depressive disorder. J Clin Psychopharmacol. 2011 Oct;31(5):643-6. doi: 10.1097/JCP.0b013e31822c6741.