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Showing 1–24 of 57 matching trials from the live ClinicalTrials.gov search.
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Filters: Intervention: Brexpiprazole Clear all
Terminated Phase 3 Interventional Results available

Long-term Safety and Tolerability Study of Brexpiprazole as Adjunctive Treatment in Patients With Major Depressive Disorder

NCT01944969
View directory record Official record
Conditions
Major Depressive Disorder
Interventions
Brexpiprazole
Drug
Lead sponsor
H. Lundbeck A/S
Industry
Eligibility
18 Years and older
Enrollment
26 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2013 – 2014
U.S. locations
1
States / cities
Orlando, Florida
Source: ClinicalTrials.gov public record
Updated Oct 16, 2018 · Synced Sep 2, 2026, 2:36 AM EDT
Completed Phase 3 Interventional Results available

Evaluation of the Safety of Adjunct Brexpiprazole in Elderly Patients With Major Depressive Disorder and an Inadequate Response to Antidepressant Treatment

NCT02400346
View directory record Official record
Conditions
Major Depression Disorder
Interventions
Adjunct brexpiprazole, ADT
Drug
Lead sponsor
H. Lundbeck A/S
Industry
Eligibility
65 Years and older
Enrollment
132 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2015 – 2016
U.S. locations
13
States / cities
Arcadia, California • Miami, Florida • Orlando, Florida + 9 more
Source: ClinicalTrials.gov public record
Updated Aug 9, 2017 · Synced Sep 2, 2026, 2:36 AM 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 2, 2026, 2:36 AM EDT
Completed Phase 1 Interventional Results available

Phase 1 Study to Assess the Safety/Tolerability of Brexpiprazole as Adjunctive Therapy in Elderly Subjects With Major Depressive Disorder

NCT01670279
View directory record Official record
Conditions
Major Depressive Disorder
Interventions
Brexpiprazole, Placebo
Drug
Lead sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Industry
Eligibility
70 Years to 85 Years
Enrollment
18 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2012 – 2013
U.S. locations
4
States / cities
Kissimmee, Florida • Miami, Florida • St Louis, Missouri + 1 more
Source: ClinicalTrials.gov public record
Updated Feb 3, 2016 · Synced Sep 2, 2026, 2:36 AM EDT
Completed Phase 3 Interventional Results available

Study of Brexpiprazole as Adjunctive Treatment of Irritability in Patients With Major Depressive Disorder and an Inadequate Response to Antidepressant Therapy

NCT01942785
View directory record Official record
Conditions
Major Depressive Disorder, Irritability
Interventions
Brexpiprazole
Drug
Lead sponsor
H. Lundbeck A/S
Industry
Eligibility
18 Years to 65 Years
Enrollment
55 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
Started 2013
U.S. locations
15
States / cities
Tucson, Arizona • Glendale, California • Oakland, California + 12 more
Source: ClinicalTrials.gov public record
Updated Mar 14, 2016 · Synced Sep 2, 2026, 2:36 AM EDT
Completed Phase 3 Interventional Results available

Brexpiprazole (OPC-34712) as an Adjunctive Treatment in Adults With Major Depressive Disorder and Anxiety Symptoms

NCT02013531
View directory record Official record
Conditions
Major Depressive Disorder, Anxiety
Interventions
Brexpiprazole
Drug
Lead sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Industry
Eligibility
18 Years to 65 Years
Enrollment
37 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2013 – 2014
U.S. locations
21
States / cities
Tuscon, Arizona • Garden Grove, California • Oceanside, California + 18 more
Source: ClinicalTrials.gov public record
Updated Mar 28, 2016 · Synced Sep 2, 2026, 2:36 AM EDT
Completed Phase 1 Interventional Results available

PET Trial to Assess the Receptor Occupancy of Brexpiprazole in Adult Subjects With Schizophrenia

NCT01854944
View directory record Official record
Conditions
Schizophrenia
Interventions
Brexpiprazole 1mg to 4mg
Drug
Lead sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Industry
Eligibility
18 Years to 45 Years
Enrollment
12 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2013 – 2014
U.S. locations
1
States / cities
New York, New York
Source: ClinicalTrials.gov public record
Updated Feb 3, 2016 · Synced Sep 2, 2026, 2:36 AM EDT
Completed No phase listed Observational

A Study to Assess Stroke Risk Among Users of Typical Versus Atypical Antipsychotics Stratified by Broad Age Group

NCT04002700
View directory record Official record
Conditions
Stroke
Interventions
Haloperidol, Typical Antipsychotics, Atypical Antipsychotics
Drug
Lead sponsor
Janssen Research & Development, LLC
Industry
Eligibility
18 Years and older
Enrollment
1,234,412 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2019
U.S. locations
1
States / cities
Titusville, New Jersey
Source: ClinicalTrials.gov public record
Updated Jun 24, 2025 · Synced Sep 2, 2026, 2:36 AM EDT
Completed Phase 3 Interventional Results available

Brexpiprazole in Treatment of Children and Adolescents With Irritability Associated With Autism Spectrum Disorder for Subjects That Have Completed Participation in 331-201-00148

NCT04258839
View directory record Official record
Conditions
Irritability Associated With Autism Spectrum Disorder
Interventions
Brexpiprazole
Drug
Lead sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Industry
Eligibility
5 Years to 17 Years
Enrollment
95 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2020 – 2023
U.S. locations
28
States / cities
Dothan, Alabama • Phoenix, Arizona • San Francisco, California + 24 more
Source: ClinicalTrials.gov public record
Updated May 29, 2024 · Synced Sep 2, 2026, 2:36 AM 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 2, 2026, 2:36 AM 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 2, 2026, 2:36 AM 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 2, 2026, 2:36 AM 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 2, 2026, 2:36 AM EDT
Enrolling by invitation Phase 4 Interventional

Precision Care for Major Depressive Disorder

NCT06580041
View directory record Official record
Conditions
Major Depressive Disorder, Depression, Depressive Disorder, Major
Interventions
Pramipexole, Methylphenidate, Phenelzine, Mindfulness-based Stress Sensitivity Therapy (MBSST), Complicated Grief Treatment (CGT), Care as usual (CAU) plan
Drug · Behavioral · Other
Lead sponsor
University of California, San Francisco
Other
Eligibility
18 Years and older
Enrollment
150 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2024 – 2029
U.S. locations
1
States / cities
San Francisco, California
Source: ClinicalTrials.gov public record
Updated Sep 4, 2025 · Synced Sep 2, 2026, 2:36 AM EDT
Completed Phase 4 Interventional Results available

Brexpiprazole for Bipolar Depression

NCT03427892
View directory record Official record
Conditions
Bipolar Depression
Interventions
Brexpiprazole
Drug
Lead sponsor
University of Texas Southwestern Medical Center
Other
Eligibility
18 Years to 65 Years
Enrollment
21 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2017 – 2018
U.S. locations
1
States / cities
Dallas, Texas
Source: ClinicalTrials.gov public record
Updated Mar 12, 2019 · Synced Sep 2, 2026, 2:36 AM EDT
Completed Phase 1 Interventional

Study to Assess the Safety, Tolerability and Pharmacokinetics of Oral Brexpiprazole (OPC- 34712) in Adolescents With Schizophrenia

NCT02411695
View directory record Official record
Conditions
Schizophrenia
Interventions
Brexpiprazole (OPC-34712)
Drug
Lead sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Industry
Eligibility
13 Years to 17 Years
Enrollment
43 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2015 – 2017
U.S. locations
10
States / cities
Little Rock, Arkansas • Culver City, California • Orange, California + 7 more
Source: ClinicalTrials.gov public record
Updated Apr 27, 2026 · Synced Sep 2, 2026, 2:36 AM EDT
Completed Phase 2 Interventional Results available

Study of the Safety and Efficacy of OPC-34712 as Adjunctive Therapy in the Treatment of Patients With Major Depressive Disorder

NCT00797966
View directory record Official record
Conditions
Major Depressive Disorder
Interventions
OPC-34712, Placebo, ADT
Drug
Lead sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Industry
Eligibility
18 Years to 65 Years
Enrollment
850 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2009 – 2010
U.S. locations
50
States / cities
Arcadia, California • Beverly Hills, California • Escondido, California + 43 more
Source: ClinicalTrials.gov public record
Updated Feb 28, 2016 · Synced Sep 2, 2026, 2:36 AM 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 2, 2026, 2:36 AM EDT
Completed Phase 4 Interventional Results available

A Study of Brexpiprazole Plus Ketamine in Treatment-Resistant Depression (TRD)

NCT03149991
View directory record Official record
Conditions
Depression
Interventions
Brexpiprazole, Ketamine, Placebo
Drug
Lead sponsor
Massachusetts General Hospital
Other
Eligibility
18 Years to 65 Years
Enrollment
51 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2017 – 2019
U.S. locations
6
States / cities
Garden Grove, California • Oakland, California • Chicago, Illinois + 3 more
Source: ClinicalTrials.gov public record
Updated Jul 23, 2020 · Synced Sep 2, 2026, 2:36 AM EDT
Completed Phase 3 Interventional Results available

A Trial to Evaluate the Safety and Tolerability of Brexpiprazole in the Treatment of Participants With Bipolar I Disorder.

NCT03287869
View directory record Official record
Conditions
Bipolar I Disorder, Acute Mania
Interventions
Brexpiprazole
Drug
Lead sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Industry
Eligibility
18 Years to 65 Years
Enrollment
381 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2017 – 2019
U.S. locations
44
States / cities
Little Rock, Arkansas • Rogers, Arkansas • Bellflower, California + 37 more
Source: ClinicalTrials.gov public record
Updated Aug 16, 2020 · Synced Sep 2, 2026, 2:36 AM EDT
Completed Phase 1 Interventional

Trial to Assess the Pharmacokinetics, Safety, Tolerability of Oral Brexpiprazole in Children (6 to <13 Years Old) With Central Nervous System Disorders

NCT03292848
View directory record Official record
Conditions
ADHD, Autism, Bipolar I Disorder, Conduct Disorder, Oppositional Defiant Disorder
Interventions
Brexpiprazole
Drug
Lead sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Industry
Eligibility
6 Years to 12 Years
Enrollment
24 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2017 – 2018
U.S. locations
9
States / cities
Little Rock, Arkansas • Rogers, Arkansas • Long Beach, California + 4 more
Source: ClinicalTrials.gov public record
Updated Jun 11, 2018 · Synced Sep 2, 2026, 2:36 AM EDT
Recruiting Phase 2 Interventional

Brexpiprazole in Alcohol Use Disorder

NCT04066192
View directory record Official record
Conditions
Alcohol Use Disorder
Interventions
Brexpiprazole, Placebo
Drug
Lead sponsor
University of Colorado, Denver
Other
Eligibility
21 Years to 65 Years
Enrollment
250 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2020 – 2026
U.S. locations
1
States / cities
Aurora, Colorado
Source: ClinicalTrials.gov public record
Updated Apr 30, 2026 · Synced Sep 2, 2026, 2:36 AM 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 2, 2026, 2:36 AM EDT
Withdrawn Phase 3 Interventional

Brexpiprazole (OPC 34712) Trial in the Treatment of Adults With Major Depressive Disorder and Irritability

NCT02212613
View directory record Official record
Conditions
Major Depressive Disorder and Irritability
Interventions
Brexpiprazole
Drug
Lead sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Industry
Eligibility
18 Years to 55 Years
Healthy volunteers
Healthy volunteers not accepted
Timeline
2014 – 2015
U.S. locations
1
States / cities
Atlanta, Georgia
Source: ClinicalTrials.gov public record
Updated Jul 6, 2016 · Synced Sep 2, 2026, 2:36 AM EDT