Study on the Efficacy, Safety, and Tolerability of Cariprazine Relative to Placebo in Participants With Bipolar I Depression



Status:Completed
Conditions:Depression, Depression, Psychiatric, Bipolar Disorder
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:18 - 65
Updated:2/1/2019
Start Date:March 17, 2016
End Date:July 19, 2017

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A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter, Fixed-Dose Clinical Trial Evaluating The Efficacy, Safety And Tolerability Of Cariprazine In Patients With Bipolar I Depression

This study investigates the efficacy of a fixed-dose regimen of cariprazine 1.5 milligram
(mg)/day or 3 mg/day compared to placebo for treatment of the depressive episode in
participants with bipolar I disorder. The safety and tolerability of the fixed-dose regimens
will be evaluated.


Inclusion Criteria:

- Currently meet the Diagnostic and Statistical Manual of Mental Disorders, Fifth
Edition (DSM-5) criteria for bipolar I disorder without psychotic features confirmed
by the administration of the Mini International Neuropsychiatric Interview (MINI),
with a current major depressive episode of at least 4 weeks and not exceeding 12
months in duration

- Currently treated as an outpatient at the time of enrollment

- A verified previous manic or mixed episode. Verification must include one of the
following sources: --Treatment of mania with an anti-manic agent (eg, lithium or
divalproate) or antipsychotic medication with an approved indication for mania
--Hospital records/Medical records --Participant report corroborated by caretaker or
previous or current treating clinician

- 17-item Hamilton Depression Rating Scale (HAMD-17) total score ≥ 20

- HAMD-17 item 1 score ≥ 2

- Clinical Global Impressions-Severity (CGI-S) score ≥ 4

- Negative serum β-human chorionic gonadotropin (β-hCG) pregnancy test (women of
childbearing potential only)

- Normal physical examination, clinical laboratory test results, and electrocardiogram
(ECG) results or abnormal findings that are judged not clinically significant by the
Principal Investigator (PI)

Exclusion Criteria:

- Young Mania Rating Scale (YMRS) total score > 12

- Four or more episodes of a mood disturbance (depression, mania, hypomania, or mixed
state) within the 12 months before Visit 1

- Any current axis 1 psychiatric diagnosis other than bipolar disorder with the
exception of specific phobias

- History of meeting DSM-5 criteria for: ○ Dementia, amnesic, or other cognitive
disorder ○ Schizophrenia, schizoaffective, or other psychotic disorder

○ Mental retardation - DSM-5-based diagnosis of borderline or antisocial personality
disorder or other axis II disorder of sufficient severity to interfere with
participation in this study

- History of meeting DSM-5 criteria for alcohol or substance abuse or dependence (other
than nicotine or caffeine) within the 6 months before Visit 1

- Positive result on blood alcohol test or urine drug screen for any prohibited
medication. Exception: ○ Participants with a positive cannabinoid on entry may be
retested before randomization. If the participant remains positive, the participant is
no longer eligible ○ Participants positive for opiates on entry, discussion with Study
Physician is required.

- Electroconvulsive therapy in the 3 months before Visit 1

- Previous lack of response to electroconvulsive therapy

- Treatment with a depot antipsychotic drug within 1 treatment cycle before Visit 1

- Treatment with clozapine in a dose of > 50 mg/day in the past 2 years

- Prior participation in any investigational study of RGH-188 or cariprazine within the
past 12 months

- Previous treatment with vagus nerve stimulation or transcranial magnetic stimulation
within 6 months before Visit 1

- Prior participation with any clinical trials, involving experimental or
investigational drugs, within 6 months before Visit 1 or during the study

- Initiation or termination of psychotherapy for depression within the 3 months
preceding Visit 1, or plans to initiate, terminate, or change such therapy during the
course of the study.

- Pregnant, breastfeeding, or planning to become pregnant or breastfeed during the study

- Gastric bypass or any condition that would be expected to affect drug absorption (lap
band procedures are acceptable if there is no problem with absorption)

- Known history of cataracts or retinal detachment

- Known human immunodeficiency virus infection

- Employee, or immediate relative of an employee, of the Sponsor, any of its affiliates
or partners, or the study center
We found this trial at
45
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Long Beach, California 90813
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3212 Cutshaw Ave
Richmond, Virginia 23230
804-353-4494
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901 Boren Avenue
Seattle, Washington 98104
206-624-4587
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Allentown, Pennsylvania 18104
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Atlanta, Georgia
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Bellevue, Washington 98007
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Berlin, New Jersey
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Burgas,
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Canton, OH
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Cedarhurst, New York 11516
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Cincinnati, Ohio 45242
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Costa Mesa, California 92626
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Dayton, OH
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Decatur, Georgia 30030
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105 South Orange Street
Escondido, California 92025
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222 West Eulalia Street
Glendale, California 91204
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Houston, Texas 17115
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Houston, Texas 77098
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Jacksonville, Florida 32256
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Kirkland, Washington 98033
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Las Vegas, Nevada 89102
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Lincoln, Rhode Island 02865
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Little Rock, AR
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Marietta, Georgia 30060
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Memphis, Tennessee 38119
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New York, New York 10023
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Norwich, Connecticut 06360
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Oakland, California 94612
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Oklahoma City, Oklahoma 73103
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Oklahoma City, Oklahoma 73112
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Orlando, Florida 32806
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Plano, Texas 75093
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San Diego, California 92123
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Sherman Oaks, California 91403
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Skokie, Illinois 60076
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Smyrna, Georgia 30080
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Tampa, Florida 33609
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Temecula, California 92591
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The Woodlands, Texas 77381
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Upland, California 91786
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Winfield, Illinois 60190
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