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Safety and Efficacy of Vilazodone in Major Depressive Disorder

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ClinicalTrials.gov Identifier: NCT01573598
Recruitment Status : Completed
First Posted : April 9, 2012
Last Update Posted : May 18, 2015
Sponsor:
Information provided by (Responsible Party):
Forest Laboratories

Brief Summary:
Safety and Efficacy of Vilazodone in Major Depressive Disorder

Condition or disease Intervention/treatment Phase
Major Depressive Disorder Drug: Placebo Drug: Vilazodone Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1219 participants
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
Study Start Date : April 2012
Actual Primary Completion Date : October 2014
Actual Study Completion Date : January 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  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. ]


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01573598


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

Responsible Party: Forest Laboratories
ClinicalTrials.gov Identifier: NCT01573598     History of Changes
Other Study ID Numbers: VLZ-MD-02
First Posted: April 9, 2012    Key Record Dates
Last Update Posted: May 18, 2015
Last Verified: May 2015

Keywords provided by Forest Laboratories:
Major Depressive Disorder
Depression

Additional relevant MeSH terms:
Depressive Disorder
Depression
Depressive Disorder, Major
Disease
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