Safety and Efficacy of Cariprazine as an Adjunctive to Antidepressant Therapy in Major Depressive Disorder



Status:Completed
Conditions:Depression, Major Depression Disorder (MDD)
Therapuetic Areas:Psychiatry / Psychology, Pulmonary / Respiratory Diseases
Healthy:No
Age Range:18 - 65
Updated:5/3/2018
Start Date:December 15, 2011
End Date:December 12, 2013

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

An outpatient study to evaluate the safety and efficacy of cariprazine as adjunct to
antidepressant therapy (ADT) in participants with major depressive disorder (MDD) who have an
inadequate response to ADT alone. This clinical study compared cariprazine + ADT with placebo
+ ADT in outpatients with a diagnosis of MDD and an inadequate response to ADT. The study
consisted of approximately 2 weeks of screening and washout followed by 8 weeks of
double-blind treatment followed by a 1 week safety follow-up.


Inclusion Criteria:

- Male or female outpatients 18 to 65 years of age, inclusive.

- Currently meet the Diagnostic and Statistical Manual of Mental Disorders, Fourth
Edition, Text Revision (DSM-IV-TR) criteria for moderate to severe major depressive
disorder (MDD).

- Current major depressive episode of at least 8 weeks and not exceeding 24 months in
duration.

- Ongoing inadequate response to protocol allowed antidepressant therapy (ADT).

Exclusion Criteria:

- Principal DSM-IV-TR-based diagnosis of an axis I disorder, other than MDD,

- Women who are pregnant, or planning to become pregnant or breastfeed during the study
or not practicing reliable contraception that will continue through out the study.

- History of meeting DSM-IV-TR criteria for:

1. Depressive episode with psychotic or catatonic features.

2. Manic, hypomanic or mixed episode, including bipolar disorder and substance
induced manic, hypomanic or mixed episode.

3. Schizophrenia, schizoaffective, or other psychotic disorder.

4. Obsessive-compulsive disorder.

5. Bulimia or anorexia nervosa.

6. Dementia, amnesic, or other cognitive disorder.

7. Mental retardation.

- Participants considered a suicide risk.
We found this trial at
42
sites
Salem, Oregon 97301
794
mi
from 91732
Salem, OR
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Albuquerque, New Mexico 87109
649
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Albuquerque, NM
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Atlanta, Georgia 30328
1917
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Atlanta, GA
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Austin, Texas 78754
1215
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Austin, TX
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Austin, Texas 78754
1215
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Austin, TX
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Bellevue, Washington 98007
959
mi
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Bellevue, WA
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Bridgeville, Pennsylvania 15017
2113
mi
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Bridgeville, PA
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Brooklyn, New York 11214
2433
mi
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Brooklyn, NY
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Canton, Ohio 44718
2047
mi
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Canton, OH
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Cherry Hill, New Jersey 08002
2382
mi
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Cherry Hill, NJ
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Creve Coeur, Missouri 63141
1559
mi
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Creve Coeur, MO
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Dallas, Texas 75230
1223
mi
from 91732
Dallas, TX
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Dayton, Ohio 45406
1894
mi
from 91732
Dayton, OH
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Flowood, Mississippi 39232
1596
mi
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Flowood, MS
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Gainesville, Florida 32607
2101
mi
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Gainesville, FL
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Garden Grove, California 92845
20
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Garden Grove, CA
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Houston, Texas 77008
1354
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Houston, TX
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Jacksonville, Florida 32216
2130
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Jacksonville, FL
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Kirkland, Washington 98033
964
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Kirkland, WA
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Kissimmee, Florida 34741
2187
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Kissimmee, FL
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Marlton, New Jersey 08053
2388
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Marlton, NJ
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Memphis, Tennessee 38119
1598
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Memphis, TN
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Miami, Florida 33133
2320
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Miami, FL
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Mount Kisco, New York 10549
2445
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Mount Kisco, NY
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National City, California 91950
110
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National City, CA
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New York, New York 10021
2432
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New York, NY
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New York, New York 10021
2432
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New York, NY
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Oceanside, California 92056
73
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Oceanside, CA
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Orange, California 92868
21
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Orange, CA
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Orange, California 92868
21
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Orange, CA
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Orange, California 92868
21
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Orange, CA
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Orlando, Florida 32806
2185
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Orlando, FL
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Philadelphia, Pennsylvania 19139
2371
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Philadelphia, PA
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Portland, Oregon 97210
829
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Portland, OR
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Prairie Village, Kansas 66206
1337
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Prairie Village, KS
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Reading, Pennsylvania 19606
2333
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Reading, PA
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Redlands, California 92374
49
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Redlands, CA
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Salt Lake City, Utah 84124
568
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Salt Lake City, UT
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San Antonio, Texas 78229
1182
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San Antonio, TX
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Sherman Oaks, California 91403
26
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Sherman Oaks, CA
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Smyrna, Georgia 30080
1911
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Smyrna, GA
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Tallinn,
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