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Safety and Efficacy of Vilazodone in Major Depressive Disorder

Information source: Forest Laboratories
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Major Depressive Disorder

Intervention: Vilazodone (Drug); Placebo to citalopram (Drug); Placebo to vilazodone (Drug); Citalopram (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Forest Laboratories

Official(s) and/or principal investigator(s):
Carl Gommoll, MS, Study Director, Affiliation: Forest Laboratories

Summary

The purpose of this study was to evaluate the efficacy, safety, and tolerability of 2 fixed dose levels of vilazodone compared to placebo in patients with major depressive disorder.

Clinical Details

Official title: A Double-blind, Placebo- and Active-controlled, Fixed-dose Study of Vilazodone in Patients With Major Depressive Disorder

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Change From Baseline in the Montgomery-├ůsberg Depression Rating Scale (MADRS) Total Score at Week 10

Secondary outcome:

Change From Baseline to Week 10 in the Clinical Global Impressions-Severity (CGI-S) Scale Score

Percentage of Participants With a Montgomery-├ůsberg Depression Rating Scale (MADRS) Sustained Response

Eligibility

Minimum age: 18 Years. Maximum age: 70 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Men and women, 18-70 years of age.

- Currently meet the Diagnostic and Statistical Manual of Mental Disorders, Fourth

Edition, Text Revision (DSM-IV-TR) criteria for Major Depressive Disorder.

- The patient's current major depressive episode must be at least 8 weeks and no longer

than 12 months in duration. Exclusion Criteria:

- Women who are pregnant, women who will be breastfeeding during the study, and women

of childbearing potential who are not practicing a reliable method of birth control.

- Patients with a history of meeting DSM-IV-TR criteria for:

- Any manic, hypomanic or mixed episode, including bipolar disorder and

substance-induced manic, hypomanic, or mixed episode

- Any depressive episode with psychotic or catatonic features

- Panic disorder with or without agoraphobia

- Obsessive-compulsive disorder

- Schizophrenia, schizoaffective, or other psychotic disorder

- Bulimia or anorexia nervosa

- Presence of borderline personality disorder or antisocial personality disorder

- Mental retardation, dementia, amnesia, or other cognitive disorders.

- Patients who are considered a suicide risk.

Locations and Contacts

Forest Investigative Site 036, Birmingham, Alabama 35216, United States

Forest Investigative Site 016, Dothan, Alabama 36303, United States

Forest Investigative Site 033, Scottsdale, Arizona 85254, United States

Forest Investigative Site 027, Fayetteville, Arkansas 72703, United States

Forest Investigative Site 029, Cerritos, California 90703, United States

Forest Investigative Site 002, Costa Mesa, California 92626, United States

Forest Investigative Site 019, Murrieta, California 92562, United States

Forest Investigative Site 025, Oceanside, California 90703, United States

Forest Investigative Site 043, Orange, California 92868, United States

Forest Investigative Site 003, Redlands, California 92374, United States

Forest Investigative Site 046, Sherman Oaks, California 33026, United States

Forest Investigative Site 057, Upland, California 91786, United States

Forest Investigative Site 034, Cromwell, Connecticut 06416, United States

Forest Investigative Site 038, Fort Myers, Florida 33912, United States

Forest Investigative Site 018, Gainsville, Florida 32607, United States

Forest Investigative Site 055, Hallandale Beach, Florida 33003, United States

Forest Investigative Site 063, Jacksonville, Florida 32256, United States

Forest Investigative Site 035, Miami, Florida 33134, United States

Forest Investigative Site 030, Orlando, Florida 32806, United States

Forest Investigative Site 062, Orlando, Florida 32806, United States

Forest Investigative Site 045, Pembroke Pines, Florida 33026, United States

Forest Investigative Site 051, Tampa, Florida 33613, United States

Forest Investigative Site 032, West Palm Beach, Florida 33407, United States

Forest Investigative Site 022, Winter Park, Florida 32789, United States

Forest Investigative Site 060, Atlanta, Georgia 30328, United States

Forest Investigative Site 037, Chicago, Illinois 60634, United States

Forest Investigative Site 050, Chicago, Illinois 60640, United States

Forest Investigative Site 040, Indianapolis, Indiana 46260, United States

Forest Investigative Site 012, Lafayette, Indiana 47905, United States

Forest Investigative Site 053, Prairie Village, Kansas 66206, United States

Forest Investigative Site 020, Baltimore, Maryland 21208, United States

Forest Investigative Site 031, Boston, Massachusetts 02135, United States

Forest Investigative Site 061, Las Vegas, Nevada 89102, United States

Forest Investigative Site 024, Willingboro, New Jersey 08046, United States

Forest Investigative Site 010, Albuquerque, New Mexico 87109, United States

Forest Investigative Site 011, Albuquerque, New Mexico 87109, United States

Forest Investigative Site 004, Brooklyn, New York 11214, United States

Forest Investigative Site 007, Cedarhurst, New York 11516, United States

Forest Investigative Site 058, New York City, New York 10003, United States

Forest Investigative Site 047, New York, New York 10021, United States

Forest Investigative Site 039, Cincinnati, Ohio 45227, United States

Forest Investigative Site 042, Oklahoma City, Oklahoma 73112, United States

Forest Investigative Site 048, Oklahoma City, Oklahoma 73112, United States

Forest Investigative Site 066, Portland, Oregon 97210, United States

Forest Investigative Site 014, Allentown, Pennsylvania 18104, United States

Forest Investigative Site 049, Bridgeville, Pennsylvania 15017, United States

Forest Investigative Site 064, Memphis, Tennessee 38119, United States

Forest Investigative Site 013, Austin, Texas 78731, United States

Forest Investigative Site 021, Dallas, Texas 75230, United States

Forest Investigative Site 059, Bellevue, Washington 98007, United States

Forest Investigative Site 065, Seattle, Washington 98104, United States

Forest Investigative Site 054, Spokane, Washington 99204, United States

Forest Investigative Site 052, Middleton, Wisconsin 53562, United States

Forest Investigative Site 056, Milwaukee, Wisconsin 53223, United States

Additional Information

Starting date: December 2011
Last updated: August 6, 2014

Page last updated: August 23, 2015

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