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Showing 1–16 of 16 matching trials from the live ClinicalTrials.gov search.
Local D1 index available.
Filters: Intervention: Brexpiprazole Matching Placebo Clear all
Completed Phase 3 Interventional Results available

A Study of Flexible-dose Brexpiprazole as Adjunctive Therapy in the Treatment of Adults With Major Depressive Disorder, the Delphinus Trial

NCT01727726
View directory record Official record
Conditions
Depressive Disorder, Depression, Depressive Disorder, Major, Mood Disorders, Mental Disorders
Interventions
Brexpiprazole, Seroquel XR, Placebo
Drug
Lead sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Industry
Eligibility
18 Years to 65 Years
Enrollment
2,182 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2012 – 2016
U.S. locations
44
States / cities
Birmingham, Alabama • Phoenix, Arizona • Little Rock, Arkansas + 39 more
Source: ClinicalTrials.gov public record
Updated Jun 7, 2018 · Synced Sep 4, 2026, 9:53 PM EDT
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

NCT03259555
View directory record Official record
Conditions
Bipolar I Disorder, Manic Episode
Interventions
Brexpiprazole, Placebo
Drug
Lead sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Industry
Eligibility
18 Years to 65 Years
Enrollment
322 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2017 – 2019
U.S. locations
29
States / cities
Little Rock, Arkansas • Rogers, Arkansas • Culver City, California + 23 more
Source: ClinicalTrials.gov public record
Updated Feb 9, 2020 · Synced Sep 4, 2026, 9:53 PM EDT
Completed Phase 2 Interventional Results available

A Study of Flexible Dose Brexpiprazole as Monotherapy or Combination Therapy in the Treatment of Adults With Post-traumatic Stress Disorder (PTSD)

NCT03033069
View directory record Official record
Conditions
Stress Disorders, Post-Traumatic
Interventions
Brexpiprazole, Sertraline, Brexpiprazole Matching Placebo, Sertraline Matching Placebo
Drug
Lead sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Industry
Eligibility
18 Years to 65 Years
Enrollment
336 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2017 – 2018
U.S. locations
54
States / cities
Tuscaloosa, Alabama • Phoenix, Arizona • Little Rock, Arkansas + 48 more
Source: ClinicalTrials.gov public record
Updated Dec 7, 2021 · Synced Sep 4, 2026, 9:53 PM EDT
Completed Phase 2 Interventional Results available

Study of the Safety and Efficacy of OPC-34712 as a Complementary Therapy in the Treatment of Adult Attention Deficit/Hyperactivity Disorder

NCT01074294
View directory record Official record
Conditions
Attention Deficit Hyperactivity Disorder
Interventions
OPDC-34712, Placebo, Stimulant Therapy
Drug
Lead sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Industry
Eligibility
18 Years to 55 Years
Enrollment
740 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2010 – 2011
U.S. locations
35
States / cities
Little Rock, Arkansas • Beverly Hills, California • Irvine, California + 32 more
Source: ClinicalTrials.gov public record
Updated Feb 1, 2023 · Synced Sep 4, 2026, 9:53 PM EDT
Completed Phase 3 Interventional Results available

A Trial to Evaluate the Safety, Efficacy, and Tolerability of Brexpiprazole in Treating Agitation Associated With Dementia of the Alzheimer's Type

NCT03548584
View directory record Official record
Conditions
Agitation Associated With Alzheimer's Dementia, Alzheimer Dementia
Interventions
Brexpiprazole, Placebo
Drug · Other
Lead sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Industry
Eligibility
55 Years to 90 Years
Enrollment
345 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2018 – 2022
U.S. locations
1
States / cities
Los Angeles, California
Source: ClinicalTrials.gov public record
Updated Sep 17, 2023 · Synced Sep 4, 2026, 9:53 PM EDT
Completed Phase 3 Interventional Results available

Brexpiprazole as Combination Therapy With Sertraline in the Treatment of Adults With Post-traumatic Stress Disorder

NCT04174170
View directory record Official record
Conditions
Post Traumatic Stress Disorder
Interventions
Brexpiprazole, Sertraline, Placebo
Drug · Other
Lead sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Industry
Eligibility
18 Years to 65 Years
Enrollment
591 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2019 – 2023
U.S. locations
1
States / cities
New York, New York
Source: ClinicalTrials.gov public record
Updated May 29, 2025 · Synced Sep 4, 2026, 9:53 PM EDT
Completed Phase 2 Interventional Results available

A Study to Assess the Safety and Efficacy of ASP4345 as Add-on Treatment for Cognitive Impairment in Subjects With Schizophrenia on Stable Doses of Antipsychotic Medication

NCT03557931
View directory record Official record
Conditions
Schizophrenia
Interventions
ASP4345, placebo, risperidone, quetiapine, olanzapine, ziprasidone, aripiprazole, brexpiprazole, paliperidone, lurasidone
Drug
Lead sponsor
Astellas Pharma Global Development, Inc.
Industry
Eligibility
18 Years to 55 Years
Enrollment
233 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2018 – 2019
U.S. locations
27
States / cities
Cerritos, California • Garden Grove, California • Lemon Grove, California + 19 more
Source: ClinicalTrials.gov public record
Updated Nov 11, 2024 · Synced Sep 4, 2026, 9:53 PM EDT
Completed Phase 2Phase 3 Interventional Results available

Evaluating the Safety and Tolerability of Brexpiprazole in the Treatment of Adults With Borderline Personality Disorder (BPD)

NCT04186403
View directory record Official record
Conditions
Borderline Personality Disorder
Interventions
Brexpiprazole
Drug
Lead sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Industry
Eligibility
18 Years to 65 Years
Enrollment
201 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2020 – 2021
U.S. locations
1
States / cities
New York, New York
Source: ClinicalTrials.gov public record
Updated Oct 2, 2024 · Synced Sep 4, 2026, 9:53 PM EDT
Completed Phase 3 Interventional Results available

Trial to Evaluate the Short-term Safety & Efficacy of Brexpiprazole Monotherapy in the Treatment of Adolescents With Schizophrenia

NCT03198078
View directory record Official record
Conditions
Schizophrenia
Interventions
Brexpiprazole (OPC-34712), Aripiprazole, Placebo
Drug
Lead sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Industry
Eligibility
13 Years to 17 Years
Enrollment
316 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2017 – 2023
U.S. locations
1
States / cities
Oklahoma City, Oklahoma
Source: ClinicalTrials.gov public record
Updated Dec 19, 2023 · Synced Sep 4, 2026, 9:53 PM EDT
Completed Phase 3 Interventional Results available

Brexpiprazole in Treatment of Children and Adolescents With Irritability Associated With Autism Spectrum Disorder

NCT04174365
View directory record Official record
Conditions
Irritability Associated With Autism Spectrum Disorder (ASD)
Interventions
Brexpiprazole, Placebo
Drug
Lead sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Industry
Eligibility
5 Years to 17 Years
Enrollment
119 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2019 – 2022
U.S. locations
1
States / cities
Princeton, New Jersey
Source: ClinicalTrials.gov public record
Updated Aug 27, 2025 · Synced Sep 4, 2026, 9:53 PM EDT
Completed Phase 3 Interventional Results available

Safety and Tolerability Study of Flexible Dosing of Brexpiprazole in the Treatment of Subjects With Agitation Associated With Dementia of the Alzheimer's Type

NCT01922258
View directory record Official record
Conditions
Agitation Associated With, Alzheimer's Disease, Alzheimer's Type, Mental Disorder, Nervous System Diseases
Interventions
Brexpiprazole, OPC-34712
Drug
Lead sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Industry
Eligibility
55 Years to 90 Years
Enrollment
270 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2013 – 2017
U.S. locations
28
States / cities
Imperial, California • Lakewood, California • Long Beach, California + 21 more
Source: ClinicalTrials.gov public record
Updated Nov 19, 2020 · Synced Sep 4, 2026, 9:53 PM EDT
Completed Phase 3 Interventional Results available

A Trial to Evaluate the Efficacy, Safety & Tolerability of Brexpiprazole in the Maintenance Treatment of Adults With Major Depressive Disorder

NCT03538691
View directory record Official record
Conditions
Major Depressive Disorder
Interventions
Brexpiprazole, Antidepressant therapy
Drug
Lead sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Industry
Eligibility
18 Years to 65 Years
Enrollment
1,149 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2018 – 2022
U.S. locations
1
States / cities
Los Angeles, California
Source: ClinicalTrials.gov public record
Updated Oct 11, 2023 · Synced Sep 4, 2026, 9:53 PM EDT
Completed Phase 3 Interventional Results available

A Phase 3, 12-week, Multicenter, Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Efficacy, Safety, and Tolerability of 2 Fixed Doses of Brexpiprazole in the Treatment of Alzheimer's Agitation

NCT01862640
View directory record Official record
Conditions
Agitation Associated With, Alzheimer's Disease, Alzheimer's Type, Mental Disorder, Nervous System Diseases
Interventions
Brexpiprazole, OPC-34712, Placebo Oral Tablet
Drug
Lead sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Industry
Eligibility
55 Years to 90 Years
Enrollment
433 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2013 – 2017
U.S. locations
37
States / cities
Tuscaloosa, Alabama • Phoenix, Arizona • Bellflower, California + 25 more
Source: ClinicalTrials.gov public record
Updated Dec 30, 2020 · Synced Sep 4, 2026, 9:53 PM EDT
Completed Phase 3 Interventional Results available

Brexpiprazole as Combination Therapy With Sertraline in Treatment of Adults With PTSD

NCT04124614
View directory record Official record
Conditions
Post Traumatic Stress Disorder
Interventions
Brexpiprazole, Sertraline, Placebo
Drug · Other
Lead sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Industry
Eligibility
18 Years to 65 Years
Enrollment
450 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2019 – 2023
U.S. locations
1
States / cities
San Diego, California
Source: ClinicalTrials.gov public record
Updated Jun 12, 2025 · Synced Sep 4, 2026, 9:53 PM EDT
Completed Phase 2 Interventional Results available

A Trial of Brexpiprazole in the Treatment of Borderline Personality Disorder

NCT04100096
View directory record Official record
Conditions
Borderline Personality Disorder
Interventions
Brexpiprazole, Placebo
Drug · Other
Lead sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Industry
Eligibility
18 Years to 65 Years
Enrollment
332 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2019 – 2021
U.S. locations
66
States / cities
Bentonville, Arkansas • Bellflower, California • Beverly Hills, California + 56 more
Source: ClinicalTrials.gov public record
Updated Jul 17, 2024 · Synced Sep 4, 2026, 9:53 PM EDT
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

NCT03257865
View directory record Official record
Conditions
Bipolar I Disorder, Manic Episode
Interventions
Brexpiprazole, Placebo
Drug
Lead sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Industry
Eligibility
18 Years to 65 Years
Enrollment
333 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2017 – 2019
U.S. locations
27
States / cities
Little Rock, Arkansas • Bellflower, California • Cerritos, California + 21 more
Source: ClinicalTrials.gov public record
Updated Feb 10, 2020 · Synced Sep 4, 2026, 9:53 PM EDT