A One Year Open Label Study Assessing the Safety and Tolerability of Vilazodone in Patients With Major Depressive Disorder (MDD)

NCT00644358 | Completed Phase 3 Results

• 1 other identifier: CLDA-07-DP-04
• Study Type: interventional
• Target: 616
• Locations: 1 country
• Sites: 38

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.

Conditions

Major Depressive Disorder

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Treatment-Emergent Adverse Events (TEAEs)

  An Adverse Event (AE) is any untoward medical occurrence in a clinical study participant administered study drug. An AE could, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the study drug, whether or not related to the medicinal product. An AE that occurred during the treatment period was defined as a TEAE if the AE was either not present at, or before, the day of the first dose of study medication or was present at, or before, the day of the first dose of study medication and increased in severity during the treatment period. AEs included abnormal clinically significant findings for laboratory parameters, physical examinations, vital signs, weight, electrocardiograms (ECGs), the Change in Sexual Functioning Questionnaire (CSFQ), ophthalmologic exams and the Columbia-Suicide Severity Rating Scale (C-SSRS).

  From first dose of study medication and up to 30 days after the last dose of study medication (Up to 13 months)

Secondary Outcomes (3)

• Change Form Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Score

  Baseline and Weeks 1, 2, 3, 4, 6 ,8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52/Early Termination

• Change From Baseline in Clinical Global Impressions - Severity (CGI-S) Score

  Baseline and Weeks 1, 2, 3, 4, 6 ,8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52/Early Termination

• Clinical Global Impression - Improvement (CGI-I) Score

  Weeks 1, 2, 3, 4, 6 ,8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52/Early Termination

Study Arms (1)

Vilazodone

EXPERIMENTAL

Vilazodone titrated up to 40 mg/day for 1 year.

Drug: vilazodone

Interventions

vilazodone DRUG

titration to 40 milligrams (mg) every day (qd) for 1 year

Also known as: EMD 68843, SB-659746

Vilazodone

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Forest Laboratories: lead

Study Sites (38)

Collaborative Neuroscience Network, Inc.

Garden Grove, California, 92845, United States

Location

Affiliated Research Institute

San Diego, California, 92108, United States

Location

Collaborative Neuroscience Network, Inc

Torrance, California, 90502, United States

Location

Pacific Clinical Research

Upland, California, 91786, United States

Location

Radiant Research

Denver, Colorado, 80239, United States

Location

CNS Clinical Research Group

Coral Springs, Florida, 33065, United States

Location

Gulfcoast Clinical Research

Fort Myers, Florida, 33912, United States

Location

Sarkis Clinical Trials

Gainesville, Florida, 32607, United States

Location

Clinical Neuroscience Solutions, Inc

Jacksonville, Florida, 32216, United States

Location

Florida Clinical Research Center, LLC

Lady Lake, Florida, 32159, United States

Location

Clinical Neuroscience Solutions, PA

Orlando, Florida, 32806, United States

Location

Stedman Clinical Trials

Tampa, Florida, 33613, United States

Location

Carman Research

Smyrna, Georgia, 30080, United States

Location

Chicago Research Center

Chicago, Illinois, 60634, United States

Location

Capstone Clinical Research

Libertyville, Illinois, 60048, United States

Location

Davis Clinic

Indianapolis, Indiana, 46260, United States

Location

Vince and Associates Clinical Research

Overland Park, Kansas, 66212, United States

Location

Capital Clinical Research Associates

Rockville, Maryland, 20852, United States

Location

Summit Research Network

Farmington, Michigan, 48336, United States

Location

Radiant Research

St Louis, Missouri, 63141, United States

Location

Radiant Research

Las Vegas, Nevada, 89146, United States

Location

Bioscience Research, LLC

Mount Kisco, New York, 10549, United States

Location

Eastside Comprehensive Medical Center

New York, New York, 10021, United States

Location

The Medical Research Network, LLC

New York, New York, 10024, United States

Location

North Coast Clinical Trials

Beachwood, Ohio, 44122, United States

Location

Patient Priority Clinical Sites, LLC

Cincinnati, Ohio, 45242, United States

Location

North Star Medical Research, LLC

Middleburg Heights, Ohio, 44130, United States

Location

IPS Research Company

Oklahoma City, Oklahoma, 73103, United States

Location

Paramount Clinical Research

Bridgeville, Pennsylvania, 15017, United States

Location

Introspect of Buxmont

Colmar, Pennsylvania, 18915, United States

Location

Suburban Research Associates

Media, Pennsylvania, 19063, United States

Location

Clinical Neuroscience Solutions

Memphis, Tennessee, 38119, United States

Location

FutureSearch Trials

Austin, Texas, 78756, United States

Location

FutureSearch Trials

Dallas, Texas, 75231, United States

Location

Croft Group Research Center

San Antonio, Texas, 78229, United States

Location

Neuropsychiatric Associates

Woodstock, Vermont, 05091, United States

Location

Neuroscience, Inc.

Herndon, Virginia, 20170, United States

Location

Dominion Clinical Research

Midlothian, Virginia, 23112, United States

Location

Related Publications (4)

• 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.

  PMID: 24127687 DERIVED

• 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.

  PMID: 23216998 DERIVED

• 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.

  PMID: 22106941 DERIVED

• 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.

  PMID: 21869687 DERIVED

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Vilazodone Hydrochloride

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indoles

Results Point of Contact

• Title: Therapeutic Area Head
• Organization: Allergan, Inc.

IR-CTRegistration@allergan.com

1-877-277-8566

Study Officials

• Carol R Reed, MD

  Forest Laboratories

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2008
• First Posted: March 26, 2008
• Study Start: December 31, 2007
• Primary Completion: May 31, 2009
• Study Completion: May 31, 2009
• Last Updated: September 25, 2017
• Results First Posted: September 25, 2017

Record last verified: 2017-08

Locations

US (38)