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
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Forest Investigative Site
Atlanta, Georgia 30328
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Arcadia, California 91007
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Bellevue, Washington 98007
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Bronx, New York 10467
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Brooklyn, New York 11214
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Canton, Ohio 44718
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Cherry Hill, New Jersey 08002
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Dayton, Ohio 45406
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Denver, Colorado 80239
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Forest Investigative Site #017
Encino, California 31316
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Forest Investigative Site 1852
Fall river, Massachusetts 02720
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Forest Investigative Site #021
Garden Grove, California 92845
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Forest Investigative Site 010
Irvine, California 92618
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Forest Investigative Site 1543
Jacksonville, Florida 32216
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Forest Investigative Site 013
Los Alamitos, California 90720
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Media, Pennsylvania 19063
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Memphis, Tennessee 38119
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Mount Kisco, New York 10549
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Forest Investigative Site 13
Nashville, Tennessee 37212
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National City, California 91950
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New York, New York 10021
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Norwich, Connecticut 06360
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Oceanside, California 92056
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Omaha, Nebraska 68131
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Forest Investigative Site 004
Overland Park, Kansas 66211
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Forest Investigative Site 019
Philadelphia, Pennsylvania 19139
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Phoenix, Arizona 85006
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Forest Investigative Site 3994
Pittsfield, Massachusetts 01201
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Portland, Oregon 97210
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Raleigh, North Carolina 27607
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Forest Investigative Site 020
Richmond, Virginia 23230
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Forest Investigative Site 1735
Roswell, Georgia 30076
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Forest Investigative Site 062
San Antonio, Texas 78229
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Forest Investigative Site 033
Scottsdale, Arizona 85254
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Forest Investigative Site #027
Seattle, Washington 98104
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Forest Investigative Site 008
Washington, District of Columbia 20010
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Forest Investigative Site 032
West Palm Beach, Florida 33407
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Forest Investigative Site 013
Woodstock, Vermont 05091
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