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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Forest Laboratories
ClinicalTrials.gov Identifier:
NCT01473394
First received: November 14, 2011
Last updated: February 21, 2014
Last verified: February 2014
  Purpose

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 Intervention Phase
Major Depressive Disorder
Drug: Dose-matched placebo
Drug: Vilazodone
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-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:
  • Change From Baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score at Week 8 [ Time Frame: Baseline to Week 8 ] [ Designated as safety issue: No ]
    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:
  • Change From Baseline in Clinical Global Impressions-Severity (CGI-S) Score at Week 8 [ Time Frame: Baseline to Week 8 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Enrollment: 518
Study Start Date: December 2011
Study Completion Date: February 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  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: NCT01473394

Locations
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
Investigators
Study Director: Carl Gommoll, MS Forest Laboratories
  More Information

No publications provided

Responsible Party: Forest Laboratories
ClinicalTrials.gov Identifier: NCT01473394     History of Changes
Other Study ID Numbers: VLZ-MD-03
Study First Received: November 14, 2011
Results First Received: February 21, 2014
Last Updated: February 21, 2014
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

ClinicalTrials.gov processed this record on July 22, 2014