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Completed

NCT Number: NCT01573598

Safety and Efficacy of Vilazodone in Major Depressive Disorder

Safety and Efficacy of Vilazodone in Major Depressive Disorder

Completed

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Key information

Conditions

Major Depressive Disorder Behavior Behavioral Symptoms Depression Depressive Disorder Depressive Disorder, Major Mental Disorders Mood Disorders

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Forest Investigative Site 103, Pleven, Bulgaria

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Placebo

Drug

Matching placebo given orally, once per day

Vilazodone

Drug

Vilazodone, 20 mg per day, oral administration

Other names: Viibryd

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Forest Laboratories

Industry

Registry information

Official study title

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Relapse Prevention Study With Vilazodone in Patients With Major Depressive Disorder

Important dates

Study start
2012
Primary completion
2014
Study completion
2015
First posted
Apr 9, 2012
Registry last updated
May 18, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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