Status:
COMPLETED
A Trial to Evaluate the Safety and Tolerability of Brexpiprazole in the Treatment of Participants With Bipolar I Disorder.
Lead Sponsor:
Otsuka Pharmaceutical Development & Commercialization, Inc.
Collaborating Sponsors:
H. Lundbeck A/S
Conditions:
Bipolar I Disorder
Acute Mania
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief Summary
This study evaluated the safety and evaluate the safety and tolerability of open-label brexpiprazole (2 - 4 mg/day, with a starting dose of 2 mg/day) for the treatment of adult subjects with bipolar I...
Detailed Description
While the availability of atypical antipsychotics had increased the therapeutic options available, there remains a need for safer and more effective therapies in the treatment of manic and depressive ...
Eligibility Criteria
Inclusion
- Inclusion Criteria (rollover participants from 331-201-00080 \& 331-201-00081 trials)
- Participants remaining in hospital at the Day 21 visit of trial 331-201-00080 or 331-201-00081 were permitted to enroll in the 331-201-00083 trial at the week 3 visit of the double-blind trial if they were planned to be discharged from the hospital before the week 1 visit of trial 331-201-0083. Participants not discharged by the week 1 visit of trial 331-201-0083 were withdrawn.
- Participants 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 participants from 331-201-00080 \& 331-201-00081 trials)
- Participants 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).
Exclusion
Key Trial Info
Start Date :
October 24 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 31 2019
Estimated Enrollment :
381 Patients enrolled
Trial Details
Trial ID
NCT03287869
Start Date
October 24 2017
End Date
July 31 2019
Last Update
August 17 2020
Active Locations (73)
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1
Woodland International Research Group
Little Rock, Arkansas, United States, 72211
2
Woodland Research Northwest, LLC
Rogers, Arkansas, United States, 72758
3
Citrials Inc.
Bellflower, California, United States, 90706
4
Radiant Research
Cerritos, California, United States, 90703