A Trial to Assess Brexpiprazole Versus Placebo for the Treatment of Acute Manic Episodes Associated With Bipolar I Disorder
Public ClinicalTrials.gov record NCT03259555. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Multicenter, Randomized, Double-blind Trial of Brexpiprazole Versus Placebo for the Acute Treatment of Manic Episodes, With or Without Mixed Features, Associated With Bipolar I Disorder
Study identification
- NCT ID
- NCT03259555
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Lead sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
- Industry
- Enrollment
- 322 participants
Conditions and interventions
Conditions
Interventions
- Brexpiprazole Drug
- Placebo Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years to 65 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Sep 13, 2017
- Primary completion
- Jan 1, 2019
- Completion
- Jan 1, 2019
- Last update posted
- Feb 9, 2020
2017 – 2019
United States locations
- U.S. sites
- 29
- U.S. states
- 12
- U.S. cities
- 26
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Woodland International Research Group | Little Rock | Arkansas | 72211 | — |
| Woodland Research Northwest, LLC | Rogers | Arkansas | 72758 | — |
| ProScience Research Group | Culver City | California | 90230 | — |
| Collaborative Neuroscience Network, LLC | Garden Grove | California | 92845 | — |
| Behavioral Research Specialists, LLC | Glendale | California | 91206 | — |
| Pacific Research Partners, LLC | Oakland | California | 94607 | — |
| NRC Research Institute | Orange | California | 92868 | — |
| Asclepes Research Centers | Panorama City | California | 91402 | — |
| Ci Trials | Riverside | California | 92506 | — |
| Sharp Vista Hospital | San Diego | California | 92123 | — |
| Galiz Research | Hialeah | Florida | 33016 | — |
| Advanced Research Institute of Miami | Homestead | Florida | 33030 | — |
| Florida Behavioral Medicine | Largo | Florida | 33770 | — |
| Optimus U Corporation | Miami | Florida | 33125 | — |
| Behavioral Clinical Research, Inc. | North Miami | Florida | 33161 | — |
| Segal Trials | North Miami | Florida | 33161 | — |
| Radiant Research Inc. | Atlanta | Georgia | 30325 | — |
| Alexian Brothers Center for Psychiatric Research | Hoffman Estates | Illinois | 60169 | — |
| CBH Health | Gaithersburg | Maryland | 20877 | — |
| Advanced Clinical Research Center, LLC | St Louis | Missouri | 63123 | — |
| Richard H Weisler, MD, PA, and Associates | Raleigh | North Carolina | 27609 | — |
| SP Research PLLC | Oklahoma City | Oklahoma | 73112 | — |
| Cutting Edge Research Group | Oklahoma City | Oklahoma | 73116 | — |
| Carolina Clinical Trials, Inc. | Charleston | South Carolina | 29407 | — |
| University of Texas at Austin | Austin | Texas | 78712 | — |
| Community Clinical Research, Inc. | Austin | Texas | 78754 | — |
| Pillar Clinical Research, LLC | Garland | Texas | 75042 | — |
| Pillar Clinical Research, LLC | Richardson | Texas | 75080 | — |
| Mid Columbia Research | Richland | Washington | 99352 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 19 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03259555, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Feb 9, 2020 · Synced May 19, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete protocol, eligibility criteria, and contact information for NCT03259555 live on ClinicalTrials.gov.