Safety and Efficacy of Vilazodone in Major Depressive Disorder

May 15, 2015 updated by: Forest Laboratories

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

Safety and Efficacy of Vilazodone in Major Depressive Disorder

Study Overview

Status

Completed

Study Type

Interventional

Enrollment (Actual)

1219

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Pleven, Bulgaria, 5800
        • Forest Investigative Site 103
      • Plovdiv, Bulgaria, 4002
        • Forest Investigative Site 104
      • Sofia, Bulgaria, 1000
        • Forest Investigative Site 106
      • Sofia, Bulgaria, 1632
        • Forest Investigative Site 102
      • Kuopio, Finland, 70110
        • Forest Investigative Site 302
      • Turku, Finland, 20100
        • Forest Investigative Site 306
      • Turku, Finland, 20100
        • Forest Investigative Site 307
    • Etelä-Suomen lääni
      • Helsinki, Etelä-Suomen lääni, Finland, 00100
        • Forest Investigative Site 304
      • Helsinki, Etelä-Suomen lääni, Finland, 00100
        • Forest Investigative Site 305
      • Helsinki, Etelä-Suomen lääni, Finland, FI-02600
        • Forest Investigative Site 301
    • Länsi-Suomen lääni
      • Rauma, Länsi-Suomen lääni, Finland, FI-26100
        • Forest Investigative Site 303
      • Berlin, Germany, 10629
        • Forest Investigative Site 403
      • Berlin, Germany, 13156
        • Forest Investigative Site 408
      • Chemnitz, Germany, 09111
        • Forest Investigative Site 407
      • Hüttenberg, Germany, 35625
        • Forest Investigative Site 402
      • Münster, Germany, 48129
        • Forest Investigative Site 409
      • Nürnberg, Germany, 90419
        • Forest Investigative Site 404
      • Westerstede, Germany, 26655
        • Forest Investigative Site 406
    • Niedersachsen
      • Hannover, Niedersachsen, Germany, 30159
        • Forest Investigative Site 401
    • Sachsen
      • Dresden, Sachsen, Germany, 1069
        • Forest Investigative Site 405
      • Arad, Romania, 310022
        • Forest Investigative Site 601
      • Iasi, Romania, 700282
        • Forest Investigative Site 603
    • Bucureşti
      • Bucuresti, Bucureşti, Romania, 7000
        • Forest Investigative Site 602
      • Moscow, Russian Federation, 115419
        • Forest Investigative Site 701
    • Kareliya, Respublika
      • Petrozavodsk, Kareliya, Respublika, Russian Federation, 185001
        • Forest Investigative Site 705
      • Beograd, Serbia, 11000
        • Forest Investigative Site 801
      • Beograd, Serbia, 11000
        • Forest Investigative Site 802
      • Kragujevac, Serbia, 34000
        • Forest Investigative Site 803
    • Beograd
      • Belgrade, Beograd, Serbia, 11000
        • Forest Investigative Site 804
    • Nišava
      • Nis, Nišava, Serbia, 18000
        • Forest Investigative Site 806
    • Šumadija
      • Kragujevac, Šumadija, Serbia, 34000
        • Forest Investigative Site 805
      • Dnipropetrovsk, Ukraine, 49005
        • Forest Investigative Site 902
      • Simferopol, Ukraine, 95006
        • Forest Investigative Site 904
    • Khersons'ka Oblast'
      • Kherson, Khersons'ka Oblast', Ukraine, 73488
        • Forest Investigative Site 903
    • L'vivs'ka Oblast'
      • Lviv, L'vivs'ka Oblast', Ukraine, 79021
        • Forest Investigative Site 901
    • Luhans'ka Oblast'
      • Lugansk, Luhans'ka Oblast', Ukraine, 91045
        • Forest Investigative Site 905
    • Odes'ka Oblast'
      • Odesa, Odes'ka Oblast', Ukraine, 67513
        • Forest Investigative Site 906
    • California
      • Beverly Hills, California, United States, 90210
        • Forest Investigative Site 030
      • Chino, California, United States, 91710
        • Forest Investigative Site 012
      • Costa Mesa, California, United States, 92626
        • Forest Investigative Site 022
      • Los Angeles, California, United States, 90024
        • Forest Investigative Site 017
      • Newport Beach, California, United States, 92660
        • Forest Investigative Site 005
      • Riverside, California, United States, 92506
        • Forest Investigative Site 027
      • San Diego, California, United States, 92103
        • Forest Investigative Site 026
    • Connecticut
      • Cromwell, Connecticut, United States, 06416
        • Forest Investigative Site 016
      • Hartford, Connecticut, United States, 06106
        • Forest Investigative Site 029
    • Florida
      • Doral, Florida, United States, 33172
        • Forest Investigative Site 020
      • Fort Myers, Florida, United States, 33912
        • Forest Investigative Site 006
      • Ft. Lauderdale, Florida, United States, 33313
        • Forest Investigative Site 007
      • Hallandale Beach, Florida, United States, 33009
        • Forest Investigative Site 004
      • Jacksonville, Florida, United States, 32256
        • Forest Investigative Site 039
      • Jacksonville Beach, Florida, United States, 32250
        • Forest Investigative Site 008
      • Leesburg, Florida, United States, 34748
        • Forest Investigative Site 015
      • Orlando, Florida, United States, 32806
        • Forest Investigative Site 035
      • West Palm Beach, Florida, United States, 33407
        • Forest Investigative Site 001
      • Winter Park, Florida, United States, 32789
        • Forest Investigative Site 034
    • Illinois
      • Hoffman Estates, Illinois, United States, 60169
        • Forest Investigative Site 019
    • Indiana
      • Indianapolis, Indiana, United States, 46260
        • Forest Investigative Site 021
    • Massachusetts
      • Boston, Massachusetts, United States, 02131
        • Forest Investigative Site 003
      • Weymouth, Massachusetts, United States, 02190
        • Forest Investigative Site 013
    • Michigan
      • Rochester Hills, Michigan, United States, 48307
        • Forest Investigative Site 028
    • New York
      • Brooklyn, New York, United States, 11214
        • Forest Investigative Site 038
      • New York, New York, United States, 10003
        • Forest Investigative Site 037
      • New York, New York, United States, 10021
        • Forest Investigative Site 032
      • New York, New York, United States, 10032
        • Forest Investigative Site 009
    • North Carolina
      • Durham, North Carolina, United States, 27705
        • Forest Investigative Site 014
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73103
        • Forest Investigative Site 025
      • Oklahoma City, Oklahoma, United States, 73112
        • Forest Investigative Site 024
    • Tennessee
      • Memphis, Tennessee, United States, 38119
        • Forest Investigative Site 036
    • Texas
      • Dallas, Texas, United States, 75080
        • Forest Investigative Site 023
      • Houston, Texas, United States, 77079
        • Forest Investigative Site 011
      • Plano, Texas, United States, 75093
        • Forest Investigative Site 010
      • San Antonio, Texas, United States, 78229
        • Forest Investigative Site 002
    • Virginia
      • Richmond, Virginia, United States, 23298
        • Forest Investigative Site 031
    • Washington
      • Bellevue, Washington, United States, 98007
        • Forest Investigative Site 033

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Dose-matched placebo capsules, oral administration
Matching placebo given orally, once per day
Experimental: Vilazodone 20mg
Vilazodone tablets, 20 mg per day, oral administration
Vilazodone, 20 mg per day, oral administration
Other Names:
  • Viibryd
Vilazodone, 40 mg once per day, oral administration
Other Names:
  • Viibryd
Experimental: Vilazodone 40mg
Vilazodone tablets, 40 mg per day, oral administration
Vilazodone, 20 mg per day, oral administration
Other Names:
  • Viibryd
Vilazodone, 40 mg once per day, oral administration
Other Names:
  • Viibryd

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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.
Number of days from the randomization date to the relapse date, up to 28 weeks.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Carrie Reichley, Forest Research Institute, a subsidiary of Actavis plc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2012

Primary Completion (Actual)

October 1, 2014

Study Completion (Actual)

January 1, 2015

Study Registration Dates

First Submitted

April 4, 2012

First Submitted That Met QC Criteria

April 5, 2012

First Posted (Estimate)

April 9, 2012

Study Record Updates

Last Update Posted (Estimate)

May 18, 2015

Last Update Submitted That Met QC Criteria

May 15, 2015

Last Verified

May 1, 2015

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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