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)



Status:Completed
Conditions:Depression, Major Depression Disorder (MDD)
Therapuetic Areas:Psychiatry / Psychology, Pulmonary / Respiratory Diseases
Healthy:No
Age Range:18 - 65
Updated:4/17/2018
Start Date:April 29, 2013
End Date:July 27, 2015

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Trial Summary
Trial Overview
Inclusion Criteria

A Phase 3, Long-Term, Open-Label Study of Safety and Tolerability of Cariprazine as Adjunctive Therapy in Major Depressive Disorder

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).


Inclusion Criteria:

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

- Meet the DSM-IV-TR criteria for MDD

- New patients must have ongoing inadequate response to protocol allowed ADTs as
reported in Antidepressant Treatment Response Questionnaire (ATRQ)

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

Exclusion Criteria:

- Patients who do not meet the DSM-IV-TR criteria for MDD
We found this trial at
89
sites
Forest Investigative Site #010
Boston, Massachusetts 02135
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Albuquerque, New Mexico 87109
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Forest Investigative Site 054
Allentown, Pennsylvania 18104
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Allentown, PA
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Atlanta, Georgia 30328
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Atlanta, GA
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Forest Investigative Site
Atlanta, Georgia 30328
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Atlanta, GA
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Forest Investigative Site 014
Austin, Texas 78754
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Austin, TX
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Forest Investigative Site
Bellevue, Washington 98007
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Bellevue, WA
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Forest Investigative Site 016
Berlin, New Jersey 08009
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Berlin, NJ
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Forest Investigative Site 020
Bismarck, North Dakota 58501
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Forest Investigative Site 014
Bothell, Washington 98011
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Forest Investigative Site 011
Bronx, New York 10467
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Bronx, NY
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Forest Investigative Site 051
Brooklyn, New York 11214
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Brooklyn, NY
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Forest Investigative Site 064
Charlottesville, Virginia 22903
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Forest Investigative Site
Chicago, Illinois 60608
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Forest Investigative Site 005
Cincinnati, Ohio 45219
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Forest Investigative Site 005
Cincinnati, Ohio 45219
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Forest Investigative site 084
Columbus, Ohio 43213
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Forest Investigative Site 037
Coral Springs, Florida 33067
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Denver, Colorado 80239
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Forest Investigative Site 004
Durham, North Carolina 27710
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Durham, NC
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Forest Investigative Site 027
Fayetteville, Arkansas 72703
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Fayetteville, AR
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Forest Investigative Site #015
Fort Myers, Florida 33912
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Fort Myers, FL
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Forest Investigative Site 049
Gaithersburg, Maryland 20877
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Gaithersburg, MD
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Forest Investigative Site #021
Garden Grove, California 92845
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Forest Investigative Site 055
Hallandale Beach, Florida 33003
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Hallandale Beach, FL
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Forest Investigative Site 1854
Hialeah, Florida 33012
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Hialeah, FL
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Forest Investigative Site 011
Hoffman Estates, Illinois 60169
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Hoffman Estates, IL
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Forest Investigative Site
Houston, Texas 77008
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Forest Investigative Site
Indianapolis, Indiana 46202
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Indianapolis, IN
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Forest Investigative Site 042
Lafayette, Indiana 47095
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Lafayette, IN
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Forest Investigative Site 074
Lauderhill, Florida 33319
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Lauderhill, FL
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Forest Investigative Site 15
Leesburg, Florida 34748
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Forest Investigative Site 032
Libertyville, Illinois 60048
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Lincoln, Rhode Island 02865
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Lincoln, RI
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Forest Investigative Site 018
Little Rock, Arkansas 72211
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Little Rock, AR
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Forest Investigative Site 018
Little Rock, Arkansas 72211
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Little Rock, AR
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Forest Investigative Site 004
Long Beach, California 90813
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Long Beach, CA
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Forest Investigative Site #029
Maitland, Florida 32751
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Maitland, FL
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Forest Investigative Site 1830
Marietta, Georgia 30066
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Marietta, GA
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Forest Investigative Site 066
Mason, Ohio 45040
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Mason, OH
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Forest Investigative Site 014
Maywood, Illinois 60153
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Maywood, IL
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Forest Investigative site 067
Miami, Florida 33133
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Miami, FL
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Forest Investigative Site 064
Middleburg Heights, Ohio 44130
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Middleburg Heights, OH
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Forest Investigative Site 007
Middleton, Wisconsin 53562
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Middleton, WI
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Forest Investigative Site 049
Milwaukee, Wisconsin 53215
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Milwaukee, WI
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Forest Investigative Site 111
Murray, Utah 84123
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Forest Investigative Site 023
Naperville, Illinois 60563
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Naperville, IL
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Forest Investigative Site 045
Natick, Massachusetts 01760
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Forest Investigative Site 019
National City, California 91950
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Forest Investigative site 030
New Orleans, Louisiana 70115
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Forest Investigative Site 025
New York, New York 10021
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Forest Investigative Site #025
Newport Beach, California 92660
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Forest Investigative Site #028
Norristown, Pennsylvania 19401
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Forest Investigative Site 001
North Charleston, South Carolina
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Forest Investigative Site #005
North Miami, Florida 33161
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Forest Investigative Site 026
Norwich, Connecticut 06360
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Forest Investigative Site 010
Oak Brook, Illinois 60523
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Forest Investigative Site 085
Oakland Park, Florida 33334
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Oceanside, California 92056
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Oklahoma City, Oklahoma 73116
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Oklahoma City, OK
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Oklahoma City, Oklahoma 73116
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Oklahoma City, Oklahoma 73116
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Forest Investigative Site 061
Orlando, Florida 32806
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Orlando, FL
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Forest Investigative Site 004
Overland Park, Kansas 66211
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Portland, Oregon 97210
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Portland, OR
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Forest Investigative Site 078
Rancho Mirage, California 92270
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Rancho Mirage, CA
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Forest Investigative Site 008
Redlands, California 92374
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Forest Investigative Site 006
Rockville, Maryland 20850
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Rockville, Maryland 20850
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Forest Investigative Site 086
Saint Charles, Missouri 63304
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Saint Charles, MO
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Forest Investigative Site 007
San Diego, California 92123
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San Diego, California 92123
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San Diego, California 92123
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Forest Investigative Site 033
San Juan, 00918
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Forest Investigative Site #027
Seattle, Washington 98104
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Forest Investigative Site 068
Skokie, Illinois 60076
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Forest Investigative Site 066
Smyrna, Georgia 30080
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Forest Investigative Site #004
South Miami, Florida 33143
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Forest Investigative Site #011
Staten Island, New York 10312
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Staten Island, NY
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Tampa, Florida 33613
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Tampa, Florida 33613
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Forest Investigative Site 011
Temecula, California 92591
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Temecula, CA
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Forest Investigative Site 045
The Woodlands, Texas 77381
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The Woodlands, TX
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Toms River, New Jersey 08755
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Toms River, NJ
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Forest Investigative site 096
Tucson, Arizona 85741
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Forest Investigative site 096
Tucson, Arizona 85741
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Forest Investigative Site 057
Waukesha, Wisconsin 53188
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Forest Investigative Site 082
Wichita Falls, Texas 76309
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Forest Investigative Site 059
Winter Park, Florida 32789
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