Safety and Efficacy of Cariprazine As Adjunctive Therapy In Major Depressive Disorder



Status:Completed
Conditions:Depression, Depression, Major Depression Disorder (MDD)
Therapuetic Areas:Psychiatry / Psychology, Pulmonary / Respiratory Diseases
Healthy:No
Age Range:18 - 65
Updated:3/7/2019
Start Date:June 30, 2009
End Date:December 6, 2010

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Trial Summary
Trial Overview
Inclusion Criteria

A Double-Blind, Placebo-Controlled Study of Cariprazine (RGH-188) As Adjunctive Therapy In Major Depressive Disorder

This is an outpatient study to evaluate the safety, and efficacy of RGH-188 as an add-on
therapy to standard antidepressants in patients who did not respond to previous
antidepressant therapy.


Inclusion Criteria:

- Men and women, 18-65 years old

- Currently meet the DSM-IV-TR criteria for moderate to severe MDD without psychotic
features.

- Previous failure to respond to adequate trials of one or two ADTs with less than 50%
reduction in depressive symptoms during the present episode.

Exclusion Criteria:

- DSM-IV-TR based diagnosis of an axis I disorder, other than MDD, or any axis I
disorder other than MDD that was the primary focus of treatment within 6 months before
Visit 1
We found this trial at
38
sites
Forest Investigative Site 051
Brooklyn, New York 11214
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Arcadia, California 91007
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Atlanta, Georgia 30328
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Bellevue, Washington 98007
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Forest Investigative Site 011
Bronx, New York 10467
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Forest Investigative Site 036
Canton, Ohio 44718
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Forest Investigative Site 023
Cherry Hill, New Jersey 08002
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Forest Investigative site 026
Dayton, Ohio 45406
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Denver, Colorado 80239
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Forest Investigative Site #017
Encino, California 31316
999
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Forest Investigative Site 1852
Fall river, Massachusetts 02720
1437
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Forest Investigative Site #021
Garden Grove, California 92845
1162
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Forest Investigative Site 010
Irvine, California 92618
1154
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Forest Investigative Site 1543
Jacksonville, Florida 32216
1055
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Forest Investigative Site 013
Los Alamitos, California 90720
1164
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Forest Investigative Site 010
Media, Pennsylvania 19063
1213
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Memphis, Tennessee 38119
479
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Forest Investigative Site 037
Mount Kisco, New York 10549
1302
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Forest Investigative Site 13
Nashville, Tennessee 37212
618
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Forest Investigative Site 019
National City, California 91950
1140
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Forest Investigative Site 025
New York, New York 10021
1286
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Forest Investigative Site 026
Norwich, Connecticut 06360
1389
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Oceanside, California 92056
1136
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Forest Investigative Site 007
Omaha, Nebraska 68131
262
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Forest Investigative Site 004
Overland Park, Kansas 66211
190
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Forest Investigative Site 019
Philadelphia, Pennsylvania 19139
1221
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Forest Investigative Site
Phoenix, Arizona 85006
851
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Forest Investigative Site 3994
Pittsfield, Massachusetts 01201
1333
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Forest Investigative Site
Portland, Oregon 97210
1385
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Portland, OR
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Forest Investigative Site
Raleigh, North Carolina 27607
1064
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Raleigh, NC
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Forest Investigative Site 020
Richmond, Virginia 23230
1109
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Forest Investigative Site 1735
Roswell, Georgia 30076
795
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Forest Investigative Site 062
San Antonio, Texas 78229
571
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Forest Investigative Site 033
Scottsdale, Arizona 85254
843
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Forest Investigative Site #027
Seattle, Washington 98104
1410
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Forest Investigative Site 008
Washington, District of Columbia 20010
1127
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Washington,
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Forest Investigative Site 032
West Palm Beach, Florida 33407
1284
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Forest Investigative Site 013
Woodstock, Vermont 05091
1376
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Woodstock, VT
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