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Safety and Efficacy of Vilazodone in Major Depressive Disorder

This study is currently recruiting participants.
Verified February 2013 by Forest Laboratories
Sponsor:
Information provided by (Responsible Party):
Forest Laboratories
ClinicalTrials.gov Identifier:
NCT01573598
First received: April 4, 2012
Last updated: February 14, 2013
Last verified: February 2013
History of Changes
  Purpose

Safety and Efficacy of Vilazodone in Major Depressive Disorder


Condition Intervention Phase
Major Depressive Disorder
 Drug: 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 Multicenter, Randomized, Double-Blind, Placebo-Controlled, Relapse Prevention Study With Vilazodone in Patients With Major Depressive Disorder

Resource links provided by NLM:

MedlinePlus related topics: Depression
U.S. FDA Resources

Further study details as provided by Forest Laboratories:

Primary Outcome Measures:
  • Time to first relapse during the double-blind treatment phase [ Time Frame: Number of days from the randomization date to the relapse date, up to 28 weeks. ] [ Designated as safety issue: No ]

Estimated Enrollment: 1500
Study Start Date: April 2012
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Dose-matched placebo capsules, oral administration
 Drug: Placebo
Matching placebo given orally, once per day
Experimental: Vilazodone 20mg
Vilazodone tablets, 20 mg per day, oral administration
 Drug: Vilazodone
Vilazodone, 20 mg per day, oral administration
Other Name: Viibryd
Experimental: Vilazodone 40mg
Vilazodone tablets, 40 mg per day, oral administration
 Drug: Vilazodone
Vilazodone, 40 mg once per day, oral administration
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 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 18 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; h. mental retardation, dementia, amnesia, or other cognitive disorders
  • Patients who are considered a suicide risk
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01573598

Contacts
Contact: Sandra Beaird, PhD 1-800-678-1605 ext 66297 FRXClinTrials@frx.com

  Show 30 Study Locations
Sponsors and Collaborators
Forest Laboratories
Investigators
Study Director: Holly Roberts, MD Forest Laboratories
  More Information

No publications provided

Responsible Party: Forest Laboratories
ClinicalTrials.gov Identifier: NCT01573598     History of Changes
Other Study ID Numbers: VLZ-MD-02
Study First Received: April 4, 2012
Last Updated: February 14, 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

ClinicalTrials.gov processed this record on May 19, 2013