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Safety and Efficacy of Vilazodone in Major Depressive Disorder

This study has been completed.
Information provided by (Responsible Party):
Forest Laboratories Identifier:
First received: April 4, 2012
Last updated: May 15, 2015
Last verified: May 2015
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
Intervention Model: Parallel Assignment
Masking: Triple (Participant, 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. ]

Enrollment: 1219
Study Start Date: April 2012
Study Completion Date: January 2015
Primary Completion Date: October 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


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

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 identifier: NCT01573598

  Show 75 Study Locations
Sponsors and Collaborators
Forest Laboratories
Study Director: Carrie Reichley Forest Research Institute, a subsidiary of Actavis plc.
  More Information

Responsible Party: Forest Laboratories Identifier: NCT01573598     History of Changes
Other Study ID Numbers: VLZ-MD-02
Study First Received: April 4, 2012
Last Updated: May 15, 2015

Keywords provided by Forest Laboratories:
Major Depressive Disorder

Additional relevant MeSH terms:
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 processed this record on September 21, 2017