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

Use our guide to learn which trials are right for you!

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
sites
Oklahoma City, Oklahoma 73112
1519
mi
from 98109
Oklahoma City, OK
Click here to add this to my saved trials
3212 Cutshaw Ave
Richmond, Virginia 23230
804-353-4494
2349
mi
from 98109
Richmond, VA
Click here to add this to my saved trials
901 Boren Avenue
Seattle, Washington 98104
206-624-4587
1
mi
from 98109
Seattle, WA
Click here to add this to my saved trials
Allentown, Pennsylvania 18104
2335
mi
from 98109
Allentown, PA
Click here to add this to my saved trials
Atlanta, Georgia
2178
mi
from 98109
Atlanta, GA
Click here to add this to my saved trials
Bellevue, Washington 98007
9
mi
from 98109
Bellevue, WA
Click here to add this to my saved trials
Berlin, New Jersey
2389
mi
from 98109
Berlin, NJ
Click here to add this to my saved trials
?
mi
from 98109
Burgas,
Click here to add this to my saved trials
2052
mi
from 98109
Canton, OH
Click here to add this to my saved trials
Cedarhurst, New York 11516
2417
mi
from 98109
Cedarhurst, NY
Click here to add this to my saved trials
Cincinnati, Ohio 45242
1969
mi
from 98109
Cincinnati, OH
Click here to add this to my saved trials
2006
mi
from 98109
Columbus, OH
Click here to add this to my saved trials
Costa Mesa, California 92626
991
mi
from 98109
Costa Mesa, CA
Click here to add this to my saved trials
1959
mi
from 98109
Dayton, OH
Click here to add this to my saved trials
Decatur, Georgia 30030
2182
mi
from 98109
Decatur, GA
Click here to add this to my saved trials
105 South Orange Street
Escondido, California 92025
1039
mi
from 98109
Escondido, CA
Click here to add this to my saved trials
222 West Eulalia Street
Glendale, California 91204
956
mi
from 98109
Glendale, CA
Click here to add this to my saved trials
Houston, Texas 17115
1890
mi
from 98109
Houston, TX
Click here to add this to my saved trials
Houston, Texas 77098
1890
mi
from 98109
Houston, TX
Click here to add this to my saved trials
Jacksonville, Florida 32256
2452
mi
from 98109
Jacksonville, FL
Click here to add this to my saved trials
Kirkland, Washington 98033
7
mi
from 98109
Kirkland, WA
Click here to add this to my saved trials
Las Vegas, Nevada 89102
874
mi
from 98109
Las Vegas, NV
Click here to add this to my saved trials
Lincoln, Rhode Island 02865
2480
mi
from 98109
Lincoln, RI
Click here to add this to my saved trials
1782
mi
from 98109
Little Rock, AR
Click here to add this to my saved trials
Long Beach, California 90813
982
mi
from 98109
Long Beach, CA
Click here to add this to my saved trials
Marietta, Georgia 30060
2163
mi
from 98109
Marietta, GA
Click here to add this to my saved trials
Memphis, Tennessee 38119
1876
mi
from 98109
Memphis, TN
Click here to add this to my saved trials
New York, New York 10023
2401
mi
from 98109
New York, NY
Click here to add this to my saved trials
Norwich, Connecticut 06360
2464
mi
from 98109
Norwich, CT
Click here to add this to my saved trials
Oakland, California 94612
678
mi
from 98109
Oakland, CA
Click here to add this to my saved trials
Oklahoma City, Oklahoma 73103
1522
mi
from 98109
Oklahoma City, OK
Click here to add this to my saved trials
Orlando, Florida 32806
2549
mi
from 98109
Orlando, FL
Click here to add this to my saved trials
Plano, Texas 75093
1667
mi
from 98109
Plano, TX
Click here to add this to my saved trials
146
mi
from 98109
Portland, OR
Click here to add this to my saved trials
1700
mi
from 98109
Saint Charles, MO
Click here to add this to my saved trials
188
mi
from 98109
Salem, OR
Click here to add this to my saved trials
San Diego, California 92123
1060
mi
from 98109
San Diego, CA
Click here to add this to my saved trials
Sherman Oaks, California 91403
953
mi
from 98109
Sherman Oaks, CA
Click here to add this to my saved trials
Skokie, Illinois 60076
1723
mi
from 98109
Skokie, IL
Click here to add this to my saved trials
Smyrna, Georgia 30080
2168
mi
from 98109
Smyrna, GA
Click here to add this to my saved trials
Tampa, Florida 33609
2525
mi
from 98109
Tampa, FL
Click here to add this to my saved trials
Temecula, California 92591
1011
mi
from 98109
Temecula, CA
Click here to add this to my saved trials
The Woodlands, Texas 77381
1866
mi
from 98109
The Woodlands, TX
Click here to add this to my saved trials
Upland, California 91786
965
mi
from 98109
Upland, CA
Click here to add this to my saved trials
Winfield, Illinois 60190
1709
mi
from 98109
Winfield, IL
Click here to add this to my saved trials