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Completed Phase 3 Interventional Results available

A Trial to Assess Brexpiprazole Versus Placebo for the Treatment of Acute Manic Episodes, Associated With Bipolar I Disorder

ClinicalTrials.gov ID: NCT03257865

Public ClinicalTrials.gov record NCT03257865. 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.

ClinicalTrials.gov public records Last synced Oct 27, 2026, 4:33 PM EDT

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 Manic Episodes, With or Without Mixed Features, Associated With Bipolar I Disorder

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT03257865
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Enrollment
333 participants

Conditions and interventions

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 19, 2017 (Actual)
Primary completion
Jan 22, 2019 (Actual)
Completion
Jan 22, 2019 (Actual)
Last update posted
Feb 11, 2020

2017 – 2019

United States locations

U.S. sites
27
U.S. states
12
U.S. cities
24
Facility City State ZIP Site status
Atria Clinical Research Little Rock Arkansas 72209 —
Woodland International Research Group, LLC Little Rock Arkansas 72211 —
CiTrials Bellflower California 90706 —
CNS Research Science Inc. Cerritos California 90703 —
Apostle Clinical Trials Long Beach California 90813 —
CNRI-San Diego San Diego California 92102 —
Artemis Institute for Clinical Research San Diego California 92103 —
CiTrials Santa Ana California 92705 —
Collaborative Neuroscience Network, LLC Torrance California 90502 —
Shreenath Clinical Service Yorba Linda California 92886 —
Galiz Research Hialeah Florida 33016 —
Research Centers of America LLC Hollywood Florida 33024 —
Optimus U Corporation Miami Florida 33125 —
South Florida Research Phase I-IV Miami Springs Florida 33166 —
Meridien Research Orlando Florida 32801 —
iResearch Atlanta, LLC Decatur Georgia 30030 —
Uptown Research Institute LLC Chicago Illinois 60640 —
Neuropsychiatric Research & Associates, LTD Winfield Illinois 60190 —
Louisiana Clinical Research Shreveport Louisiana 71101 —
Arch Clinical Trials, LLC St Louis Missouri 63118 —
St Louis Clinical Trials LLC St Louis Missouri 63141 —
Hassman Research Institute Berlin New Jersey 08009 —
CNS Research Science, Inc. Jamaica New York 11432 —
New Hope Clinical Research Charlotte North Carolina 28211 —
University of Cincinnati Department of Psychiatry and Behavorial Science Cincinnati Ohio 45219 —
InSite Clinical Research LLC DeSoto Texas 75115 —
Pillar Clinical Research, LLC Richardson Texas 75080 —

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 11 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT03257865, 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 11, 2020 · Synced Oct 27, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT03257865 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →