A Cariprazine Study in the Prevention of Relapse in Bipolar I Disorder Patients Whose Current Episode is Manic or Depressive, With or Without Mixed Features



Status:Recruiting
Conditions:Depression, Psychiatric, Psychiatric, Bipolar Disorder
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:18 - 65
Updated:7/1/2018
Start Date:June 15, 2018
End Date:July 17, 2021
Contact:Clinical Trial Registry Team
Email:IR-CTRegistration@allergan.com
Phone:877-277-8566

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A Double-blind, Placebo-controlled, Randomized Withdrawal, Multicenter Clinical Trial Evaluating the Efficacy, Safety and Tolerability of Cariprazine in a Dose-reduction Paradigm in the Prevention of Relapse in Bipolar I Disorder Patients Whose Current Episode is Manic or Depressive, With or Without Mixed Features

1) To evaluate the efficacy and safety of cariprazine at a target dose of 3.0 mg/d compared
with placebo in prevention of relapse in patients with bipolar I disorder whose current
episode (i.e. index episode) is manic or depressive, with or without mixed features; 2) To
evaluate the efficacy and safety of cariprazine at a target dose of 1.5 mg/d compared with
placebo in prevention of relapse in patients with bipolar I disorder whose current episode
(i.e. index episode) is manic or depressive, with or without mixed features who were
initially stabilized on a target dose of 3.0 mg/d


Inclusion Criteria:

- Currently meet the Diagnostic and Statistical Manual of Mental Disorders, Fifth
Edition (DSM-5) criteria for bipolar I disorder, current episode manic, with or
without mixed features

- A total YMRS score ≥ 20 and a score of at least 4 on 2 of the following YMRS items:
irritability, speech, content, and disruptive/aggressive behavior, or bipolar I
disorder, current episode depressive, with or without mixed features

- Having a MADRS total score ≥ 23 and a score of at least 3 on 2 of the following MADRS
items: apparent sadness, reported sadness, inner tension or inability to feel

Exclusion Criteria:

- Four or more episodes of a mood disturbance within the 12 months before Visit 1

- Diagnosis of another psychiatric disorder other than bipolar disorder with the
exception of specific phobias
We found this trial at
42
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Maitland, Florida 32751
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4202 E Fowler Ave
Tampa, Florida 33620
(813) 974-2011
University of South Florida The University of South Florida is a high-impact, global research university...
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Anaheim, CA
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Arlington Heights, Illinois 60005
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Atlanta, Georgia
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Atlanta, GA
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811 Juniper St NE
Atlanta, Georgia 30308
(404) 881-5800
Atlanta Center for Medical Research Welcome to the Atlanta Center for Medical Research, a leader...
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Austin, Texas 78754
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Beavercreek, Ohio 45432
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Berlin, New Jersey
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Burgas,
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Cedarhurst, New York 11516
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Cerritos, California 90703
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Charlotte, North Carolina 28204
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110 South Parkside Drive
Colorado Springs, Colorado 80910
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Columbus, Ohio 43210
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Costa Mesa, California 92626
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Culver City, California 90230
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Dayton, OH
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Decatur, Georgia 30030
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Gaithersburg, Maryland 20877
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Garden Grove, California 92845
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630 North Coit Road
Garland, Texas 75042
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Glendale, California 91204
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7261 Sheridan Street
Hollywood, Florida 33024
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La Habra, California 90631
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Las Vegas, Nevada 89102
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Lauderhill, Florida 33319
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Little Rock, Arkansas 72211
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Long Beach, California 90804
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National City, California 91950
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Oklahoma City, Oklahoma 73112
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Orange, CA
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Panorama City, California 91402
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Raleigh, North Carolina 27609
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Richardson, Texas 75080
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609 West Dyke Road
Rogers, Arkansas 72758
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Saint Charles, MO
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San Diego, California 92102
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San Diego, California 92123
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San Marcos, California 92078
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Shreveport, Louisiana 71115
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The Woodlands, Texas 77381
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