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

November 14, 2011
September 28, 2013
November 2011
June 2013   (final data collection date for primary outcome measure)
Montgomery-Åsberg Depression Rating Scale (MÅDRS) [ Time Frame: 10 Weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01473381 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Safety and Efficacy of Vilazodone in Major Depressive Disorder
A Double-Blind, Placebo- and Active-Controlled, Fixed-Dose Study of Vilazodone in Patients With Major Depressive Disorder

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Major Depressive Disorder
  • Drug: Placebo
    Dose-matched placebo. Oral administration, once per day.
  • Drug: Vilazodone
    Vilazodone 20 mg. Oral administration, once per day.
    Other Name: Viibryd
  • Drug: Vilazodone
    Vilazodone 40 mg. Oral administration, once per day.
    Other Name: Viibryd
  • Drug: Citalopram
    Citalopram 40 mg. Oral administration, once per day.
    Other Name: Celexa
  • Placebo Comparator: Placebo
    Matching placebo capsules, oral administration
    Intervention: Drug: Placebo
  • Experimental: Vilazodone 20mg
    20 mg/day vilazodone tablets, oral administration
    Intervention: Drug: Vilazodone
  • Experimental: Vilazodone 40mg
    40 mg/day vilazodone tablets, oral administration
    Intervention: Drug: Vilazodone
  • Active Comparator: Citalopram
    Citalopram, 40 mg/day, oral administration, once daily
    Intervention: Drug: Citalopram
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1159
August 2013
June 2013   (final data collection date for primary outcome measure)

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
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01473381
VLZ-MD-01
No
Forest Laboratories
Forest Laboratories
Not Provided
Study Director: Carl Gommoll, MS Forest Laboratories
Forest Laboratories
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP