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NCT03259555 · ClinicalTrials.gov registry record · Phase 3
A Trial to Assess Brexpiprazole Versus Placebo for the Treatment of Acute Manic Episodes Associated With Bipolar I Disorder
A Phase 3 study of Bipolar I Disorder and Manic Episode, sponsored by Otsuka Pharmaceutical Development & Commercialization.
- Completed
- Registry status
- Phase 3
- Development phase
- 322
- Enrollment target
- 20
- Study locations
NCT03259555: Completed Phase 3 study of Bipolar I Disorder and Manic Episode, sponsored by Otsuka Pharmaceutical Development & Commercialization.
NCT03259555 is a Phase 3 study of Bipolar I Disorder and Manic Episode that has completed, run by Otsuka Pharmaceutical Development & Commercialization. The registered enrollment target is 322 participants, roughly in line with the 318-participant average among 26 other Bipolar I Disorder trials with a reported enrollment target. The trial reports 20 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03259555, a Phase 3 study of Bipolar I Disorder and Manic Episode, has completed, sponsored by Otsuka Pharmaceutical Development & Commercialization.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 322 participants
- Enrollment target
- 20
- Study locations
Study Summary
To demonstrate the efficacy of brexpiprazole for the acute treatment of manic episodes, with or without mixed features, in participants with a diagnosis of bipolar I disorder.
Primary Outcome
The YMRS was utilized to assess a participant's level of manic symptoms. It consists of 11 items: 1) elevated mood, 2) increased motor activity-energy, 3) sexual interest, 4) sleep, 5) irritability, 6) speech (rate and amount), 7) language-thought disorder, 8) content, 9) disruptive-aggressive behavior, 10) appearance, and 11) insight. Seven items are rated on a 0- to 4-scale, while four items (Items 5, 6, 8, and 9) are rated on a 0- to 8-scale with 0, 2, 4, 6, and 8 being the possible scores (t
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Brexpiprazole
Study Locations (20)
California
- ProScience Research Group - Culver City
- Collaborative Neuroscience Network, LLC - Garden Grove
- Behavioral Research Specialists, LLC - Glendale
- Pacific Research Partners, LLC - Oakland
- NRC Research Institute - Orange
- Asclepes Research Centers - Panorama City
- Ci Trials - Riverside
- Sharp Vista Hospital - San Diego
Florida
- Galiz Research - Hialeah
- Advanced Research Institute of Miami - Homestead
- Florida Behavioral Medicine - Largo
- Optimus U Corporation - Miami
- Behavioral Clinical Research, Inc. - North Miami
- Segal Trials - North Miami
Arkansas
- Woodland International Research Group - Little Rock
- Woodland Research Northwest, LLC - Rogers
Georgia
- Radiant Research Inc. - Atlanta
Illinois
- Alexian Brothers Center for Psychiatric Research - Hoffman Estates
Maryland
- CBH Health - Gaithersburg
Missouri
- Advanced Clinical Research Center, LLC - St Louis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 322 participants |
| Start Date | 2017-09-14 |
| Est. Completion | 2019-01-02 |
| Phase | Phase 3 |
What the finished NCT03259555 record still lists
NCT03259555 is an interventional study that assigns participants to a tested intervention. The registered 322 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 318-participant average among 26 other Bipolar I Disorder trials with a reported enrollment target.
The record links to 2 conditions, with Bipolar I Disorder appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT03259555 names 20 study sites across 7 states, led by California, Florida, Arkansas.
Frequently Asked Questions
What is clinical trial NCT03259555 about?
NCT03259555 is a clinical study titled "A Trial to Assess Brexpiprazole Versus Placebo for the Treatment of Acute Manic Episodes Associated With Bipolar I Disorder". To demonstrate the efficacy of brexpiprazole for the acute treatment of manic episodes, with or without mixed features, in participants with a diagnosis of bipolar I disorder.
What is the current status of trial NCT03259555?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 322 participants. The study started on 2017-09-14. Estimated completion is 2019-01-02.
What conditions does trial NCT03259555 study?
This clinical trial studies the following conditions: Bipolar I Disorder, Manic Episode.
What interventions are being tested in trial NCT03259555?
The interventions under investigation include: Placebo (DRUG), Brexpiprazole (DRUG).
Who is sponsoring clinical trial NCT03259555?
This trial is sponsored by Otsuka Pharmaceutical Development & Commercialization, which has 221 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03259555 being conducted?
This trial has 20 study locations across Arkansas, California, Florida, Georgia, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Bipolar I Disorder
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03259555's enrollment target sits among peer trials
322 9th of 26 higher than 18 of 26 other Bipolar I Disorder trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Bipolar I Disorder trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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