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NCT03257865 · 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
- 333
- Enrollment target
- 20
- Study locations
NCT03257865: Completed Phase 3 study of Bipolar I Disorder and Manic Episode, sponsored by Otsuka Pharmaceutical Development & Commercialization.
NCT03257865 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 333 participants, roughly in line with the 317-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
NCT03257865, 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
- 333 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
- CiTrials - Bellflower
- CNS Research Science Inc. - Cerritos
- Apostle Clinical Trials - Long Beach
- CNRI-San Diego - San Diego
- Artemis Institute for Clinical Research - San Diego
- CiTrials - Santa Ana
- Collaborative Neuroscience Network, LLC - Torrance
- Shreenath Clinical Service - Yorba Linda
Florida
- Galiz Research - Hialeah
- Research Centers of America LLC - Hollywood
- Optimus U Corporation - Miami
- South Florida Research Phase I-IV - Miami Springs
- Meridien Research - Orlando
Arkansas
- Atria Clinical Research - Little Rock
- Woodland International Research Group, LLC - Little Rock
Illinois
- Uptown Research Institute LLC - Chicago
- Neuropsychiatric Research & Associates, LTD - Winfield
Georgia
- iResearch Atlanta, LLC - Decatur
Louisiana
- Louisiana Clinical Research - Shreveport
Missouri
- Arch Clinical Trials, LLC - St Louis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 333 participants |
| Start Date | 2017-09-19 |
| Est. Completion | 2019-01-22 |
| Phase | Phase 3 |
What the finished NCT03257865 record still lists
NCT03257865 is an interventional study that assigns participants to a tested intervention. The registered 333 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 317-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.
NCT03257865 names 20 study sites across 7 states, led by California, Florida, Arkansas.
Frequently Asked Questions
What is clinical trial NCT03257865 about?
NCT03257865 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 NCT03257865?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 333 participants. The study started on 2017-09-19. Estimated completion is 2019-01-22.
What conditions does trial NCT03257865 study?
This clinical trial studies the following conditions: Bipolar I Disorder, Manic Episode.
What interventions are being tested in trial NCT03257865?
The interventions under investigation include: Placebo (DRUG), Brexpiprazole (DRUG).
Who is sponsoring clinical trial NCT03257865?
This trial is sponsored by Otsuka Pharmaceutical Development & Commercialization, which has 221 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03257865 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 NCT03257865's enrollment target sits among peer trials
333 8th of 26 higher than 19 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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