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

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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visit of trial 331-201-0083 must be withdrawn.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).
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263 Farmington Ave
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(860) 679-2000
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