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 |
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.
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.
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visit of trial 331-201-0083 must be withdrawn.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
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Farmington, Connecticut 06030
Farmington, Connecticut 06030
(860) 679-2000
University of Connecticut Health Center UConn Health is a vibrant, integrated academic medical center that...
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