Long-term Safety and Tolerability of Cariprazine as an Adjunctive Treatment to Antidepressant Therapy in Patients With Major Depressive Disorder

Last updated: July 29, 2019
Sponsor: Forest Laboratories
Overall Status: Completed

Phase

3

Condition

Depression

Affective Disorders

Depression (Major/severe)

Treatment

N/A

Clinical Study ID

NCT01838876
RGH-MD-76
  • Ages 18-65
  • All Genders

Study Summary

The objective of this study is to evaluate the long-term safety and tolerability of cariprazine as an adjunctive treatment to antidepressant therapy (ADT) in patients with Major Depressive Disorder (MDD).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients who have provided consent prior to any study specific procedures

  • Meets the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, TextRevision (DSM-IV-TR) criteria for MDD

  • New patients must have ongoing inadequate response to protocol allowed ADTs asreported in Antidepressant Treatment Response Questionnaire (ATRQ)

  • For rollover patients from RGH-MD-72 [NCT01715805], completion of Study RGH-MD-72 (either double-blind or single-blind treatment periods) with continued ADT treatment.

Exclusion

Exclusion Criteria:

  • Patients who do not meet the DSM-IV-TR criteria for MDD.

Study Design

Total Participants: 442
Study Start date:
April 29, 2013
Estimated Completion Date:
July 27, 2015

Connect with a study center

  • Forest Investigative Site 033

    San Juan, 00918
    Puerto Rico

    Site Not Available

  • Forest Investigative Site 034

    San Juan, 00927
    Puerto Rico

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  • Forest Investigative Site 032

    Tucson, Arizona 85710
    United States

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  • Forest Investigative Site 109

    Tucson, Arizona 85724
    United States

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  • Forest Investigative Site 105

    Fayetteville, Arkansas 72703
    United States

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  • Forest Investigative Site 018

    Little Rock, Arkansas 72211
    United States

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  • Forest Investigative Site 029

    Little Rock, Arkansas 72211
    United States

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  • Forest Investigative Site 082

    Garden Grove, California 92845
    United States

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  • Forest Investigative Site 107

    Long Beach, California 90822
    United States

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  • Forest Investigative Site 104

    National City, California 91950
    United States

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  • Forest Investigative Site 022

    Newport Beach, California 92660
    United States

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  • Forest Investigative Site 004

    Oceanside, California 92056
    United States

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  • Forest Investigative Site 078

    Rancho Mirage, California 92270
    United States

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  • Forest Investigative Site 080

    Redlands, California 92374
    United States

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  • Forest Investigative Site 007

    San Diego, California 92123
    United States

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  • Forest Investigative Site 054

    San Diego, California 92108
    United States

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  • Forest Investigative Site 113

    San Diego, California 92102
    United States

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  • Forest Investigative Site 031

    Temecula, California 92591
    United States

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  • Forest Investigative Site 048

    Denver, Colorado 80239
    United States

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  • Forest Investigative Site 114

    Norwich, Connecticut 06360
    United States

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  • Forest Investigative Site 037

    Coral Springs, Florida 33067
    United States

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  • Forest Investigative Site 053

    Fort Meyers, Florida 33912
    United States

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  • Forest Investigative Site 053

    Fort Myers, Florida 33912
    United States

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  • Forest Investigative Site 023

    Hallandale Beach, Florida 33009
    United States

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  • Forest Investigative Site 071

    Hialeah, Florida 33012
    United States

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  • Forest Investigative Site 074

    Lauderhill, Florida 33319
    United States

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  • Forest Investigative Site 006

    Leesburg, Florida 34748
    United States

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  • Forest Investigative Site 112

    Maitland, Florida 32751
    United States

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  • Forest Investigative Site 026

    Miami, Florida 33145
    United States

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    Miami, Florida 33165
    United States

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  • Forest Investigative Site 027

    North Miami, Florida 33161
    United States

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  • Forest Investigative Site 074

    North Miami, Florida 33161
    United States

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  • Forest Investigative Site 036

    Oakland Park, Florida 33334
    United States

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  • Forest Investigative Site 051

    Orlando, Florida 32803
    United States

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  • Forest Investigative Site 044

    South Miami, Florida 33143
    United States

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  • Forest Investigative Site 008

    Tampa, Florida 33613
    United States

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  • Forest Investigative Site 019

    Winter Park, Florida 32789
    United States

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  • Forest Investigative Site 024

    Atlanta, Georgia 30331
    United States

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  • Forest Investigative Site 060

    Atlanta, Georgia 30329
    United States

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  • Forest Investigative Site 017

    Marietta, Georgia 30060
    United States

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  • Forest Investigative Site 047

    Smyma, Georgia 30080
    United States

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  • Forest Investigative Site 047

    Smyrna, Georgia 30080
    United States

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  • Forest Investigative Site 070

    Chicago, Illinois 60612
    United States

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  • Forest Investigative Site 013

    Hoffman Estates, Illinois 60169
    United States

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  • Forest Investigative Site 063

    Libertyville, Illinois 60048
    United States

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  • Forest Investigative Site 062

    Maywood, Illinois 60153
    United States

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  • Forest Investigative Site 072

    Naperville, Illinois 60563
    United States

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  • Forest Investigative Site 010

    Oak Brook, Illinois 60523
    United States

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  • Forest Investigative Site 068

    Skokie, Illinois 60076
    United States

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  • Forest Investigative Site 061

    Indianapolis, Indiana 46260
    United States

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    Lafayette, Indiana 47905
    United States

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    Overland Park, Kansas 66211
    United States

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  • Forest Investigative Site 073

    New Orleans, Louisiana 70115
    United States

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  • Forest Investigative Site 049

    Gaithersburg, Maryland 20877
    United States

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    Rockville, Maryland 20850
    United States

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  • Forest Investigative Site 110

    Rockville, Maryland 20852
    United States

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  • Forest Investigative Site 046

    Boston, Massachusetts 02131
    United States

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  • Forest Investigative Site 045

    Natick, Massachusetts 01760
    United States

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  • Forest Investigative Site 103

    Saint Charles, Missouri 63304
    United States

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  • Forest Investigative Site 103

    St Charles, Missouri 63304
    United States

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  • Forest Investigative Site 106

    Berlin, New Jersey 08009
    United States

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  • Forest Investigative Site 014

    Toms River, New Jersey 08755
    United States

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  • Forest Investigative Site 058

    Albuquerque, New Mexico 87109
    United States

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  • Forest Investigative Site 058

    Alburquerque, New Mexico 87109
    United States

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  • Forest Investigative Site 076

    Bronx, New York 10467
    United States

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  • Forest Investigative Site 028

    Brooklyn, New York 11214
    United States

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  • Forest Investigative Site 016

    New York, New York 10023
    United States

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  • Forest Investigative Site 025

    Staten Island, New York 10305
    United States

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  • Forest Investigative Site 050

    Durham, North Carolina 27710
    United States

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  • Forest Investigative Site 067

    Bismarck, North Dakota 58501
    United States

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    Bismark, North Dakota 58501
    United States

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  • Forest Investigative Site 011

    Cincinnati, Ohio 45219
    United States

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  • Forest Investigative Site 015

    Cincinnati, Ohio 45227
    United States

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    Columbus, Ohio 43210
    United States

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    Mason, Ohio 45040
    United States

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    Middleburg Heights, Ohio 44130
    United States

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  • Forest Investigative Site 035

    Oklahoma City, Oklahoma 73103
    United States

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  • Forest Investigative Site 038

    Oklahoma City, Oklahoma 72112
    United States

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  • Forest Investigative Site 039

    Oklahoma City, Oklahoma 73112
    United States

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  • Forest Investigative Site 003

    Portland, Oregon 97210
    United States

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  • Forest Investigative Site 052

    Allentown, Pennsylvania 18104
    United States

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    Norristown, Pennsylvania 19403
    United States

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  • Forest Investigative Site 059

    Lincoln, Rhode Island 02865
    United States

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  • Forest Investigative Site 001

    Charleston, South Carolina 29425
    United States

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  • Forest Investigative Site 001

    North Charleston, South Carolina 29406
    United States

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  • Forest Investigative Site 079

    Austin, Texas 78732
    United States

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  • Forest Investigative Site 005

    Houston, Texas 77008
    United States

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  • Forest Investigative Site 108

    The Woodlands, Texas 77381
    United States

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  • Forest Investigative Site 069

    Wichita Falls, Texas 76309
    United States

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  • Forest Investigative Site 108

    Woodlands, Texas 77381
    United States

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  • Forest Investigative Site 111

    Murray, Utah 84123
    United States

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  • Forest Investigative Site 041

    Charlottesville, Virginia 22903
    United States

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  • Forest Investigative Site 081

    Bellevue, Washington 98007
    United States

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  • Forest Investigative Site 100

    Bothell, Washington 98011
    United States

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  • Forest Investigative Site 043

    Seattle, Washington 98104
    United States

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  • Forest Investigative Site 101

    Middleton, Wisconsin 53562
    United States

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  • Forest Investigative Site 056

    Milwaukee, Wisconsin 53227
    United States

    Site Not Available

  • Forest Investigative Site 057

    Waukesha, Wisconsin 53188
    United States

    Site Not Available

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