Safety and Efficacy of Vilazodone in Major Depressive Disorder

Last updated: May 15, 2015
Sponsor: Forest Laboratories
Overall Status: Completed

Phase

4

Condition

Mood Disorders

Depression (Major/severe)

Depression

Treatment

N/A

Clinical Study ID

NCT01573598
VLZ-MD-02
  • Ages 18-70
  • All Genders

Study Summary

Safety and Efficacy of Vilazodone in Major Depressive Disorder

Eligibility Criteria

Inclusion

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 longerthan 18 months in duration

Exclusion

Exclusion Criteria:

  • Women who are pregnant, women who will be breastfeeding during the study, and women ofchildbearing 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 andsubstance-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 Design

Total Participants: 1219
Study Start date:
April 01, 2012
Estimated Completion Date:
January 31, 2015

Connect with a study center

  • Forest Investigative Site 103

    Pleven, 5800
    Bulgaria

    Site Not Available

  • Forest Investigative Site 104

    Plovdiv, 4002
    Bulgaria

    Site Not Available

  • Forest Investigative Site 102

    Sofia, 1632
    Bulgaria

    Site Not Available

  • Forest Investigative Site 106

    Sofia, 1000
    Bulgaria

    Site Not Available

  • Forest Investigative Site 105

    Varna, 9010
    Bulgaria

    Site Not Available

  • Forest Investigative Site 301

    Helsinki, Etelä-Suomen lääni FI-02600
    Finland

    Site Not Available

  • Forest Investigative Site 304

    Helsinki, Etelä-Suomen lääni 00100
    Finland

    Site Not Available

  • Forest Investigative Site 305

    Helsinki, Etelä-Suomen lääni 00100
    Finland

    Site Not Available

  • Forest Investigative Site 303

    Rauma, Länsi-Suomen lääni FI-26100
    Finland

    Site Not Available

  • Forest Investigative Site 302

    Kuopio, 70110
    Finland

    Site Not Available

  • Forest Investigative Site 306

    Turku, 20100
    Finland

    Site Not Available

  • Forest Investigative Site 307

    Turku, 20100
    Finland

    Site Not Available

  • Forest Investigative Site 401

    Hannover, Niedersachsen 30159
    Germany

    Site Not Available

  • Forest Investigative Site 405

    Dresden, Sachsen 1069
    Germany

    Site Not Available

  • Forest Investigative Site 403

    Berlin, 10629
    Germany

    Site Not Available

  • Forest Investigative Site 408

    Berlin, 13156
    Germany

    Site Not Available

  • Forest Investigative Site 407

    Chemnitz, 09111
    Germany

    Site Not Available

  • Forest Investigative Site 402

    Hüttenberg, 35625
    Germany

    Site Not Available

  • Forest Investigative Site 409

    Münster, 48129
    Germany

    Site Not Available

  • Forest Investigative Site 404

    Nürnberg, 90419
    Germany

    Site Not Available

  • Forest Investigative Site 406

    Westerstede, 26655
    Germany

    Site Not Available

  • Forest Investigative Site 602

    Bucuresti, Bucureşti 7000
    Romania

    Site Not Available

  • Forest Investigative Site 601

    Arad, 310022
    Romania

    Site Not Available

  • Forest Investigative Site 603

    Iasi, 700282
    Romania

    Site Not Available

  • Forest Investigative Site 705

    Petrozavodsk, Kareliya, Respublika 185001
    Russian Federation

    Site Not Available

  • Forest Investigative Site 706

    Lipetsk, 398007
    Russian Federation

    Site Not Available

  • Forest Investigative Site 701

    Moscow, 115419
    Russian Federation

    Site Not Available

  • Forest Investigative Site 702

    Yaroslavl, 150003
    Russian Federation

    Site Not Available

  • Forest Investigative Site 804

    Belgrade, Beograd 11000
    Serbia

    Site Not Available

  • Forest Investigative Site 806

    Nis, Nišava 18000
    Serbia

    Site Not Available

  • Forest Investigative Site 805

    Kragujevac, Šumadija 34000
    Serbia

    Site Not Available

  • Forest Investigative Site 801

    Beograd, 11000
    Serbia

    Site Not Available

  • Forest Investigative Site 802

    Beograd, 11000
    Serbia

    Site Not Available

  • Forest Investigative Site 803

    Kragujevac, 34000
    Serbia

    Site Not Available

  • Forest Investigative Site 903

    Kherson, Khersons'ka Oblast' 73488
    Ukraine

    Site Not Available

  • Forest Investigative Site 901

    Lviv, L'vivs'ka Oblast' 79021
    Ukraine

    Site Not Available

  • Forest Investigative Site 905

    Lugansk, Luhans'ka Oblast' 91045
    Ukraine

    Site Not Available

  • Forest Investigative Site 906

    Odesa, Odes'ka Oblast' 67513
    Ukraine

    Site Not Available

  • Forest Investigative Site 902

    Dnipropetrovsk, 49005
    Ukraine

    Site Not Available

  • Forest Investigative Site 904

    Simferopol, 95006
    Ukraine

    Site Not Available

  • Forest Investigative Site 030

    Beverly Hills, California 90210
    United States

    Site Not Available

  • Forest Investigative Site 012

    Chino, California 91710
    United States

    Site Not Available

  • Forest Investigative Site 022

    Costa Mesa, California 92626
    United States

    Site Not Available

  • Forest Investigative Site 017

    Los Angeles, California 90024
    United States

    Site Not Available

  • Forest Investigative Site 005

    Newport Beach, California 92660
    United States

    Site Not Available

  • Forest Investigative Site 027

    Riverside, California 92506
    United States

    Site Not Available

  • Forest Investigative Site 026

    San Diego, California 92103
    United States

    Site Not Available

  • Forest Investigative Site 016

    Cromwell, Connecticut 06416
    United States

    Site Not Available

  • Forest Investigative Site 029

    Hartford, Connecticut 06106
    United States

    Site Not Available

  • Forest Investigative Site 020

    Doral, Florida 33172
    United States

    Site Not Available

  • Forest Investigative Site 006

    Fort Myers, Florida 33912
    United States

    Site Not Available

  • Forest Investigative Site 007

    Ft. Lauderdale, Florida 33313
    United States

    Site Not Available

  • Forest Investigative Site 004

    Hallandale Beach, Florida 33009
    United States

    Site Not Available

  • Forest Investigative Site 039

    Jacksonville, Florida 32256
    United States

    Site Not Available

  • Forest Investigative Site 008

    Jacksonville Beach, Florida 32250
    United States

    Site Not Available

  • Forest Investigative Site 015

    Leesburg, Florida 34748
    United States

    Site Not Available

  • Forest Investigative Site 035

    Orlando, Florida 32806
    United States

    Site Not Available

  • Forest Investigative Site 001

    West Palm Beach, Florida 33407
    United States

    Site Not Available

  • Forest Investigative Site 034

    Winter Park, Florida 32789
    United States

    Site Not Available

  • Forest Investigative Site 019

    Hoffman Estates, Illinois 60169
    United States

    Site Not Available

  • Forest Investigative Site 021

    Indianapolis, Indiana 46260
    United States

    Site Not Available

  • Forest Investigative Site 003

    Boston, Massachusetts 02131
    United States

    Site Not Available

  • Forest Investigative Site 013

    Weymouth, Massachusetts 02190
    United States

    Site Not Available

  • Forest Investigative Site 028

    Rochester Hills, Michigan 48307
    United States

    Site Not Available

  • Forest Investigative Site 038

    Brooklyn, New York 11214
    United States

    Site Not Available

  • Forest Investigative Site 009

    New York, New York 10032
    United States

    Site Not Available

  • Forest Investigative Site 032

    New York, New York 10021
    United States

    Site Not Available

  • Forest Investigative Site 037

    New York, New York 10003
    United States

    Site Not Available

  • Forest Investigative Site 014

    Durham, North Carolina 27705
    United States

    Site Not Available

  • Forest Investigative Site 024

    Oklahoma City, Oklahoma 73112
    United States

    Site Not Available

  • Forest Investigative Site 025

    Oklahoma City, Oklahoma 73103
    United States

    Site Not Available

  • Forest Investigative Site 036

    Memphis, Tennessee 38119
    United States

    Site Not Available

  • Forest Investigative Site 023

    Dallas, Texas 75080
    United States

    Site Not Available

  • Forest Investigative Site 011

    Houston, Texas 77079
    United States

    Site Not Available

  • Forest Investigative Site 010

    Plano, Texas 75093
    United States

    Site Not Available

  • Forest Investigative Site 002

    San Antonio, Texas 78229
    United States

    Site Not Available

  • Forest Investigative Site 031

    Richmond, Virginia 23298
    United States

    Site Not Available

  • Forest Investigative Site 033

    Bellevue, Washington 98007
    United States

    Site Not Available

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