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

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

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
sites
Costa Mesa, California 92626
?
mi
from
Costa Mesa, CA
Click here to add this to my saved trials
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...
?
mi
from
Tampa, FL
Click here to add this to my saved trials
?
mi
from
Anaheim, CA
Click here to add this to my saved trials
Arlington Heights, Illinois 60005
?
mi
from
Arlington Heights, IL
Click here to add this to my saved trials
Atlanta, Georgia
?
mi
from
Atlanta, GA
Click here to add this to my saved trials
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...
?
mi
from
Atlanta, GA
Click here to add this to my saved trials
Austin, Texas 78754
?
mi
from
Austin, TX
Click here to add this to my saved trials
Beavercreek, Ohio 45432
?
mi
from
Beavercreek, OH
Click here to add this to my saved trials
Berlin, New Jersey
?
mi
from
Berlin, NJ
Click here to add this to my saved trials
?
mi
from
Burgas,
Click here to add this to my saved trials
Cedarhurst, New York 11516
?
mi
from
Cedarhurst, NY
Click here to add this to my saved trials
Cerritos, California 90703
?
mi
from
Cerritos, CA
Click here to add this to my saved trials
Charlotte, North Carolina 28204
?
mi
from
Charlotte, NC
Click here to add this to my saved trials
110 South Parkside Drive
Colorado Springs, Colorado 80910
?
mi
from
Colorado Springs, CO
Click here to add this to my saved trials
Columbus, Ohio 43210
?
mi
from
Columbus, OH
Click here to add this to my saved trials
Culver City, California 90230
?
mi
from
Culver City, CA
Click here to add this to my saved trials
?
mi
from
Dayton, OH
Click here to add this to my saved trials
Decatur, Georgia 30030
?
mi
from
Decatur, GA
Click here to add this to my saved trials
Gaithersburg, Maryland 20877
?
mi
from
Gaithersburg, MD
Click here to add this to my saved trials
Garden Grove, California 92845
?
mi
from
Garden Grove, CA
Click here to add this to my saved trials
630 North Coit Road
Garland, Texas 75042
?
mi
from
Garland, TX
Click here to add this to my saved trials
Glendale, California 91204
?
mi
from
Glendale, CA
Click here to add this to my saved trials
7261 Sheridan Street
Hollywood, Florida 33024
?
mi
from
Hollywood, FL
Click here to add this to my saved trials
La Habra, California 90631
?
mi
from
La Habra, CA
Click here to add this to my saved trials
Las Vegas, Nevada 89102
?
mi
from
Las Vegas, NV
Click here to add this to my saved trials
Lauderhill, Florida 33319
?
mi
from
Lauderhill, FL
Click here to add this to my saved trials
Little Rock, Arkansas 72211
?
mi
from
Little Rock, AR
Click here to add this to my saved trials
Long Beach, California 90804
?
mi
from
Long Beach, CA
Click here to add this to my saved trials
Maitland, Florida 32751
?
mi
from
Maitland, FL
Click here to add this to my saved trials
National City, California 91950
?
mi
from
National City, CA
Click here to add this to my saved trials
Oklahoma City, Oklahoma 73112
?
mi
from
Oklahoma City, OK
Click here to add this to my saved trials
?
mi
from
Orange, CA
Click here to add this to my saved trials
Panorama City, California 91402
?
mi
from
Panorama City, CA
Click here to add this to my saved trials
Raleigh, North Carolina 27609
?
mi
from
Raleigh, NC
Click here to add this to my saved trials
Richardson, Texas 75080
?
mi
from
Richardson, TX
Click here to add this to my saved trials
609 West Dyke Road
Rogers, Arkansas 72758
?
mi
from
Rogers, AR
Click here to add this to my saved trials
?
mi
from
Saint Charles, MO
Click here to add this to my saved trials
San Diego, California 92102
?
mi
from
San Diego, CA
Click here to add this to my saved trials
San Diego, California 92123
?
mi
from
San Diego, CA
Click here to add this to my saved trials
San Marcos, California 92078
?
mi
from
San Marcos, CA
Click here to add this to my saved trials
Shreveport, Louisiana 71115
?
mi
from
Shreveport, LA
Click here to add this to my saved trials
The Woodlands, Texas 77381
?
mi
from
The Woodlands, TX
Click here to add this to my saved trials