Safety and Efficacy of Vilazodone in Major Depressive Disorder

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Forest Laboratories
ClinicalTrials.gov Identifier:
NCT01573598
First received: April 4, 2012
Last updated: March 24, 2014
Last verified: March 2014
  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:


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
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: NCT01573598

  Show 75 Study Locations
Sponsors and Collaborators
Forest Laboratories
Investigators
Study Director: Suresh Durgam, 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: March 24, 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 28, 2014