Phase 3
Completed N=381
A Trial to Evaluate the Safety and Tolerability of Brexpiprazole in the Treatment of Participants With Bipolar I Disorder.
Bipolar I Disorder · Acute Mania
Source: ClinicalTrials.gov NCT03287869 ↗
Enrolled (actual)
381
Serious AEs
5.2%
Results posted
Aug 2020
Primary outcomePrimary: Number of Participants With at Least One Treatment Emergent Adverse Event (TEAE) by Severity — 79; 86; 60; 68 Participants
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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 disorder. All participants received a starting dose of brexpiprazole.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With at Least One Treatment Emergent Adverse Event (TEAE) by Severity |
79; 86; 60; 68; 31; 29 | — |
Eligibility Criteria
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 Participants not discharged by the week 1 visit of trial 331-201-0083 were withdrawn.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).
Data sourced from ClinicalTrials.gov (NCT03287869). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.