A Trial to Evaluate the Safety and Tolerability of Brexpiprazole in the Treatment of Subjects With Bipolar I Disorder



Status:Recruiting
Conditions:Psychiatric, Bipolar Disorder
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:18 - 65
Updated:11/1/2018
Start Date:October 24, 2017
End Date:July 2019
Contact:Erin Foster
Email:erin.foster@syneoshealth.com
Phone:+1 (949) 202-3258

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

A Multicenter, Open-label Trial to Evaluate the Safety and Tolerability of Brexpiprazole in the Treatment of Subjects With Bipolar I Disorder

This study will evaluate the safety and tolerability of brexpiprazole (OPC-34712) in the
treatment of subjects with bipolar I disorder. All subjects will receive a starting dose of
brexpiprazole which will be titrated up in subsequent visits.

While the availability of atypical antipsychotics have increased the therapeutic options
available, there remains a need for safer and more effective therapies in the treatment of
manic and depressive episodes of bipolar I disorder. Brexpiprazole's specific receptor
activity profile likely correlates with its established efficacy in schizophrenia and major
depressive disorder, and may prove to be an effective target for the treatment of acute mania
of bipolar I disorder.

Inclusion Criteria (rollover subjects from 331-201-00080 & 331-201-00081 trials)

- Subjects remaining in hospital at the day 21 visit of trial 331-201-00080 or
331-201-00081 will be permitted to enroll in the 331-201-00083 trial at the week 3
visit of the double-blind trial if they are planned to be discharged from the hospital
before the week 1 visit of trial 331-201-0083. Subjects not discharged by the week 1
visit of trial 331-201-0083 must be withdrawn.

- Subjects who, in the opinion of the investigator, could potentially benefit from
administration of oral brexpiprazole for the treatment of bipolar I disorder and who
completed 3 weeks of post-randomization treatment in Trial 331-201-00080 & Trial
331-201-00081

Exclusion Criteria (rollover subjects from 331-201-00080 & 331-201-00081 trials)

- Subjects with a major protocol violation during the course of their participation in
the double-blind phase 3 trials (331-201-00080 or 331-201-00081).
We found this trial at
57
sites
Charlotte, North Carolina 28204
?
mi
from
Charlotte, NC
Click here to add this to my saved trials
Atlanta, Georgia
?
mi
from
Atlanta, GA
Click here to add this to my saved trials
Austin, Texas 78712
?
mi
from
Austin, TX
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
Bellflower, California 90706
?
mi
from
Bellflower, CA
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
Cerritos, California 90703
?
mi
from
Cerritos, CA
Click here to add this to my saved trials
Charleston, South Carolina 29405
?
mi
from
Charleston, SC
Click here to add this to my saved trials
Chicago, Illinois 60640
?
mi
from
Chicago, IL
Click here to add this to my saved trials
?
mi
from
Cincinnati, OH
Click here to add this to my saved trials
2020 Ponce de Leon Boulevard
Coral Gables, Florida 33134
?
mi
from
Coral Gables, FL
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
Decatur, Georgia 30030
?
mi
from
Decatur, GA
Click here to add this to my saved trials
DeSoto, Texas 75115
?
mi
from
DeSoto, TX
Click here to add this to my saved trials
Everett, Washington 98201
?
mi
from
Everett, WA
Click here to add this to my saved trials
263 Farmington Ave
Farmington, Connecticut 06030
(860) 679-2000
University of Connecticut Health Center UConn Health is a vibrant, integrated academic medical center that...
?
mi
from
Farmington, CT
Click here to add this to my saved trials
1065 Northeast 125th Street
Fort Lauderdale, Florida 33308
?
mi
from
Fort Lauderdale, FL
Click here to add this to my saved trials
200 West Magnolia Avenue
Fort Worth, Texas 76104
?
mi
from
Fort Worth, TX
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
Glendale, California 91204
?
mi
from
Glendale, CA
Click here to add this to my saved trials
Hialeah, Florida 33016
?
mi
from
Hialeah, FL
Click here to add this to my saved trials
Hoffman Estates, Illinois 60169
?
mi
from
Hoffman Estates, IL
Click here to add this to my saved trials
Hollywood, Florida 33021
?
mi
from
Hollywood, FL
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
Homestead, Florida 33035
?
mi
from
Homestead, FL
Click here to add this to my saved trials
80-15 164th Street
Jamaica, New York 11432
?
mi
from
Jamaica, NY
Click here to add this to my saved trials
Largo, Florida 33770
?
mi
from
Largo, FL
Click here to add this to my saved trials
Little Rock, Arkansas
?
mi
from
Little Rock, AR
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 90813
?
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
?
mi
from
Miami, FL
Click here to add this to my saved trials
Oakland, California 94612
?
mi
from
Oakland, CA
Click here to add this to my saved trials
Oklahoma City, Oklahoma 73116
?
mi
from
Oklahoma City, OK
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
Orange, California 92868
?
mi
from
Orange, CA
Click here to add this to my saved trials
14860 Roscoe Boulevard
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
Richland, Washington 99352
?
mi
from
Richland, WA
Click here to add this to my saved trials
Riverside, California 92705
?
mi
from
Riverside, CA
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
4801 Weldon Spring Parkway
Saint Charles, Missouri 63301
?
mi
from
Saint Charles, MO
Click here to add this to my saved trials
Saint Louis, Missouri 63141
?
mi
from
Saint Louis, MO
Click here to add this to my saved trials
Saint Louis, Missouri 63118
?
mi
from
Saint Louis, MO
Click here to add this to my saved trials
4950 Childrens Place
Saint Louis, Missouri 63123
?
mi
from
Saint Louis, 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 Diego, California 92123
?
mi
from
San Diego, CA
Click here to add this to my saved trials
801 North Tustin Avenue
Santa Ana, California 92705
?
mi
from
Santa Ana, 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
?
mi
from
Tampa, FL
Click here to add this to my saved trials
Torrance, California 90502
?
mi
from
Torrance, CA
Click here to add this to my saved trials
Winfield, Illinois 60190
?
mi
from
Winfield, IL
Click here to add this to my saved trials
Yorba Linda, California 92886
?
mi
from
Yorba Linda, CA
Click here to add this to my saved trials