Safety and Efficacy of Vilazodone in Major Depressive Disorder (VLZ-MD-01)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Forest Laboratories
ClinicalTrials.gov Identifier:
NCT01473381
First received: November 14, 2011
Last updated: September 28, 2013
Last verified: September 2013
  Purpose

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


Condition Intervention Phase
Major Depressive Disorder
Drug: Placebo
Drug: Vilazodone
Drug: Citalopram
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double-Blind, Placebo- and Active-Controlled, Fixed-Dose Study of Vilazodone in Patients With Major Depressive Disorder

Resource links provided by NLM:


Further study details as provided by Forest Laboratories:

Primary Outcome Measures:
  • Montgomery-Åsberg Depression Rating Scale (MÅDRS) [ Time Frame: 10 Weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Clinical Global Impressions - Severity (CGI-S) [ Time Frame: 10 Weeks ] [ Designated as safety issue: No ]
  • MÅDRS Sustained Remission [ Time Frame: 10 Weeks ] [ Designated as safety issue: No ]

Enrollment: 1159
Study Start Date: November 2011
Study Completion Date: August 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Matching placebo capsules, oral administration
Drug: Placebo
Dose-matched placebo. Oral administration, once per day.
Experimental: Vilazodone 20mg
20 mg/day vilazodone tablets, oral administration
Drug: Vilazodone
Vilazodone 20 mg. Oral administration, once per day.
Other Name: Viibryd
Experimental: Vilazodone 40mg
40 mg/day vilazodone tablets, oral administration
Drug: Vilazodone
Vilazodone 40 mg. Oral administration, once per day.
Other Name: Viibryd
Active Comparator: Citalopram
Citalopram, 40 mg/day, oral administration, once daily
Drug: Citalopram
Citalopram 40 mg. Oral administration, once per day.
Other Name: Celexa

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01473381

  Hide Study Locations
Locations
United States, Alabama
Forest Investigative Site 036
Birmingham, Alabama, United States, 35216
Forest Investigative Site 016
Dothan, Alabama, United States, 36303
United States, Arizona
Forest Investigative Site 033
Scottsdale, Arizona, United States, 85254
United States, Arkansas
Forest Investigative Site 027
Fayetteville, Arkansas, United States, 72703
United States, California
Forest Investigative Site 029
Cerritos, California, United States, 90703
Forest Investigative Site 002
Costa Mesa, California, United States, 92626
Forest Investigative Site 019
Murrieta, California, United States, 92562
Forest Investigative Site 025
Oceanside, California, United States, 90703
Forest Investigative Site 043
Orange, California, United States, 92868
Forest Investigative Site 003
Redlands, California, United States, 92374
Forest Investigative Site 046
Sherman Oaks, California, United States, 33026
Forest Investigative Site 057
Upland, California, United States, 91786
United States, Connecticut
Forest Investigative Site 034
Cromwell, Connecticut, United States, 06416
United States, Florida
Forest Investigative Site 038
Fort Myers, Florida, United States, 33912
Forest Investigative Site 018
Gainsville, Florida, United States, 32607
Forest Investigative Site 055
Hallandale Beach, Florida, United States, 33003
Forest Investigative Site 063
Jacksonville, Florida, United States, 32256
Forest Investigative Site 035
Miami, Florida, United States, 33134
Forest Investigative Site 030
Orlando, Florida, United States, 32806
Forest Investigative Site 062
Orlando, Florida, United States, 32806
Forest Investigative Site 045
Pembroke Pines, Florida, United States, 33026
Forest Investigative Site 051
Tampa, Florida, United States, 33613
Forest Investigative Site 032
West Palm Beach, Florida, United States, 33407
Forest Investigative Site 022
Winter Park, Florida, United States, 32789
United States, Georgia
Forest Investigative Site 060
Atlanta, Georgia, United States, 30328
United States, Illinois
Forest Investigative Site 037
Chicago, Illinois, United States, 60634
Forest Investigative Site 050
Chicago, Illinois, United States, 60640
United States, Indiana
Forest Investigative Site 040
Indianapolis, Indiana, United States, 46260
Forest Investigative Site 012
Lafayette, Indiana, United States, 47905
United States, Kansas
Forest Investigative Site 053
Prairie Village, Kansas, United States, 66206
United States, Maryland
Forest Investigative Site 020
Baltimore, Maryland, United States, 21208
United States, Massachusetts
Forest Investigative Site 031
Boston, Massachusetts, United States, 02135
United States, Nevada
Forest Investigative Site 061
Las Vegas, Nevada, United States, 89102
United States, New Jersey
Forest Investigative Site 024
Willingboro, New Jersey, United States, 08046
United States, New Mexico
Forest Investigative Site 010
Albuquerque, New Mexico, United States, 87109
Forest Investigative Site 011
Albuquerque, New Mexico, United States, 87109
United States, New York
Forest Investigative Site 004
Brooklyn, New York, United States, 11214
Forest Investigative Site 007
Cedarhurst, New York, United States, 11516
Forest Investigative Site 047
New York, New York, United States, 10021
Forest Investigative Site 058
New York City, New York, United States, 10003
United States, Ohio
Forest Investigative Site 039
Cincinnati, Ohio, United States, 45227
United States, Oklahoma
Forest Investigative Site 042
Oklahoma City, Oklahoma, United States, 73112
Forest Investigative Site 048
Oklahoma City, Oklahoma, United States, 73112
United States, Oregon
Forest Investigative Site 066
Portland, Oregon, United States, 97210
United States, Pennsylvania
Forest Investigative Site 014
Allentown, Pennsylvania, United States, 18104
Forest Investigative Site 049
Bridgeville, Pennsylvania, United States, 15017
United States, Tennessee
Forest Investigative Site 064
Memphis, Tennessee, United States, 38119
United States, Texas
Forest Investigative Site 013
Austin, Texas, United States, 78731
Forest Investigative Site 021
Dallas, Texas, United States, 75230
United States, Washington
Forest Investigative Site 059
Bellevue, Washington, United States, 98007
Forest Investigative Site 065
Seattle, Washington, United States, 98104
Forest Investigative Site 054
Spokane, Washington, United States, 99204
United States, Wisconsin
Forest Investigative Site 052
Middleton, Wisconsin, United States, 53562
Forest Investigative Site 056
Milwaukee, Wisconsin, United States, 53223
Sponsors and Collaborators
Forest Laboratories
Investigators
Study Director: Carl Gommoll, MS Forest Laboratories
  More Information

No publications provided

Responsible Party: Forest Laboratories
ClinicalTrials.gov Identifier: NCT01473381     History of Changes
Other Study ID Numbers: VLZ-MD-01
Study First Received: November 14, 2011
Last Updated: September 28, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Forest Laboratories:
Major Depressive Disorder
Depression

Additional relevant MeSH terms:
Depressive Disorder
Depression
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms
Citalopram
Dexetimide
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Agents
Physiological Effects of Drugs
Antiparkinson Agents
Anti-Dyskinesia Agents
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents

ClinicalTrials.gov processed this record on July 20, 2014