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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

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Major Depressive Disorder Drug: Dose-matched placebo Drug: Vilazodone Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 518 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double-blind, Placebo-controlled, Fixed-dose Study of Vilazodone in Patients With Major Depressive Disorder
Study Start Date : December 2011
Actual Primary Completion Date : February 2013
Actual Study Completion Date : February 2013

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Placebo Comparator: Dose-matched placebo
Participants received dose-matched placebo orally once daily for 9 weeks.
Drug: Dose-matched placebo
Dose-matched placebo was supplied as tablets.

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.
Drug: Vilazodone
Vilazodone was supplied as tablets.
Other Name: Viibryd

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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.

  2. 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.

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01473394

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United States, California
Forest Investigative Site 009
Beverly Hills, California, United States, 90210
Forest Investigative Site 003
Encino, California, United States, 91316
Forest Investigative Site 010
New port Beach, California, United States, 92660
United States, Florida
Forest Investigative Site 005
Jacksonville, Florida, United States, 32216
Forest Investigative Site 004
Orlando, Florida, United States, 32806
United States, Georgia
Forest Investigative Site 012
Atlanta, Georgia, United States, 30328
United States, Maryland
Forest Investigative Site 001
Baltimore, Maryland, United States, 21285
United States, Ohio
Forest Investigative Site 002
Dayton, Ohio, United States, 45417
United States, Pennsylvania
Forest Investigative Site 011
Philadelphia, Pennsylvania, United States, 19104
United States, Rhode Island
Forest Investigative Site 015
Lincoln, Rhode Island, United States, 02865
United States, Tennessee
Forest Investigative Site 008
Memphis, Tennessee, United States, 38119
United States, Texas
Forest Investigative Site 016
San Antonio, Texas, United States, 78229
United States, Washington
Forest Investigative Site 006
Bellevue, Washington, United States, 98007
Forest Investigative Site 013
Seattle, Washington, United States, 98104
Sponsors and Collaborators
Forest Laboratories
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Study Director: Carl Gommoll, MS Forest Laboratories
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Forest Laboratories Identifier: NCT01473394    
Other Study ID Numbers: VLZ-MD-03
First Posted: November 17, 2011    Key Record Dates
Results First Posted: April 3, 2014
Last Update Posted: April 3, 2014
Last Verified: February 2014
Keywords provided by Forest Laboratories:
Major depressive disorder
Additional relevant MeSH terms:
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Depressive Disorder
Depressive Disorder, Major
Pathologic Processes
Mood Disorders
Mental Disorders
Behavioral Symptoms
Vilazodone Hydrochloride
Antidepressive Agents
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Serotonin 5-HT1 Receptor Agonists
Serotonin Receptor Agonists