Safety, Efficacy, and Tolerability of Vilazodone in Major Depressive Disorder

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01473394
Recruitment Status : Completed
First Posted : November 17, 2011
Results First Posted : April 3, 2014
Last Update Posted : April 3, 2014
Information provided by (Responsible Party):
Forest Laboratories

November 14, 2011
November 17, 2011
February 21, 2014
April 3, 2014
April 3, 2014
December 2011
February 2013   (Final data collection date for primary outcome measure)
Change From Baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score at Week 8 [ Time Frame: Baseline to Week 8 ]
The MADRS is a clinician-rated scale for assessing depressive symptomatology that had occurred in participants during the week preceding each interview. Patients were rated on 10 items to assess feelings of sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty concentrating, and lack of interest. Each item was scored on a 7-point scale from 0 (no symptoms) to 6 (symptoms of maximum severity). The total score was the sum of the scores on the 10 items and ranged from 0 to 60. A higher score indicated more depressive symptomatology. A negative change score indicated improvement.
Montgomery-Åsberg Depression Rating Scale (MÅDRS) [ Time Frame: 8 weeks ]
Complete list of historical versions of study NCT01473394 on Archive Site
  • Change From Baseline in Clinical Global Impressions-Severity (CGI-S) Score at Week 8 [ Time Frame: Baseline to Week 8 ]
    The CGI-S is a clinician-rated scale for assessing the severity of the participant's current state of mental illness compared with a patient population with major depressive disorder. The clinician responded to the following question "Considering your total clinical experience with this population, how mentally ill is the participant at this time?" on a 7-point scale: 1=normal, not at all ill; 2=borderline ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=among the most extremely ill patients. The scale ranges from 1 to 7. A higher score indicates more severe mental illness. A negative change score indicates improvement.
  • Percentage of Participants With a Montgomery-Åsberg Depression Rating Scale (MADRS) Sustained Response Rate [ Time Frame: Baseline to Week 8 ]
    The MADRS Sustained response rate is defined as a MÅDRS total score ≤ 12 for at least the last 2 consecutive visits during the double-blind treatment period.
  • Clinical Global Impressions - Severity (CGI-S) [ Time Frame: 8 weeks ]
  • MÅDRS Response [ Time Frame: 8 weeks ]
  • Hamilton Rating Scale for Anxiety (HAM-A) [ Time Frame: 8 weeks ]
Not Provided
Not Provided
Safety, Efficacy, and Tolerability of Vilazodone in Major Depressive Disorder
A Double-blind, Placebo-controlled, Fixed-dose Study of Vilazodone in Patients With Major Depressive Disorder
The purpose of this study was to further characterize the efficacy, safety, and tolerability of a single fixed dose level of vilazodone compared to placebo in patients with major depressive disorder.
Not Provided
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Major Depressive Disorder
  • Drug: Dose-matched placebo
    Dose-matched placebo was supplied as tablets.
  • Drug: Vilazodone
    Vilazodone was supplied as tablets.
    Other Name: Viibryd
  • Placebo Comparator: Dose-matched placebo
    Participants received dose-matched placebo orally once daily for 9 weeks.
    Intervention: Drug: Dose-matched placebo
  • Experimental: Vilazodone
    Participants received vilazodone orally once daily for 9 weeks, as follows: Week 1, 10 mg once a day; Week 2, 20 mg once a day; Weeks 3 to 8, 40 mg once a day; and Week 9 (down-taper period), 20 mg once a day for 4 days, then 10 mg once a day for 3 days.
    Intervention: Drug: Vilazodone

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
February 2013
February 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.
Sexes Eligible for Study: All
18 Years to 70 Years   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
United States
Not Provided
Not Provided
Forest Laboratories
Forest Laboratories
Not Provided
Study Director: Carl Gommoll, MS Forest Laboratories
Forest Laboratories
February 2014

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