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ClinicalTrials.gov public records Last synced Sep 30, 2026, 2:40 PM EDT

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Showing 25–39 of 39 matching trials from the live ClinicalTrials.gov search.
Filters: Intervention: Brexpiprazole 3 mg Clear all
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 24, 2020 · Synced Sep 30, 2026, 2:40 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 12, 2023 · Synced Sep 30, 2026, 2:40 PM EDT
Terminated Phase 3 Interventional Results available

Efficacy and Safety of Brexpiprazole as Adjunctive Treatment in Elderly Patients With Major Depressive Disorder With an Inadequate Response to Antidepressant Treatment

NCT01837797
View directory record Official record
Conditions
Major Depressive Disorder
Interventions
Placebo, Brexpiprazole 1 mg, Brexpiprazole 3 mg
Drug
Lead sponsor
H. Lundbeck A/S
Industry
Eligibility
65 Years and older
Enrollment
129 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2013 – 2014
U.S. locations
2
States / cities
National City, California • Orlando, Florida
Source: ClinicalTrials.gov public record
Updated Oct 17, 2018 · Synced Sep 30, 2026, 2:40 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 18, 2024 · Synced Sep 30, 2026, 2:40 PM EDT
Completed Phase 3 Interventional Results available

Brexpiprazole as Adjunctive Treatment in Patients With Major Depressive Disorder With an Inadequate Response to Antidepressant Treatment

NCT01838681
View directory record Official record
Conditions
Major Depressive Disorder
Interventions
Placebo, Brexpiprazole, ADT
Drug
Lead sponsor
H. Lundbeck A/S
Industry
Eligibility
18 Years to 75 Years
Enrollment
1,986 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2013 – 2016
U.S. locations
8
States / cities
Little Rock, Arkansas • Cerritos, California • Temecula, California + 4 more
Source: ClinicalTrials.gov public record
Updated Aug 9, 2017 · Synced Sep 30, 2026, 2:40 PM EDT
Terminated Phase 3 Interventional Results available

Brexpiprazole as an Adjunctive Treatment to Paroxetine or Sertraline in Adult Patients Suffering From Post-traumatic Stress Disorder (PTSD)

NCT01987960
View directory record Official record
Conditions
Post-traumatic Stress Disorder, PTSD
Interventions
Placebo, Brexpiprazole
Drug
Lead sponsor
H. Lundbeck A/S
Industry
Eligibility
18 Years to 65 Years
Enrollment
417 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2013 – 2015
U.S. locations
22
States / cities
Los Angeles, California • Riverside, California • San Diego, California + 17 more
Source: ClinicalTrials.gov public record
Updated Mar 13, 2017 · Synced Sep 30, 2026, 2:40 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 10, 2020 · Synced Sep 30, 2026, 2:40 PM 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 28, 2026 · Synced Sep 30, 2026, 2:40 PM 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 12, 2018 · Synced Sep 30, 2026, 2:40 PM 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 15, 2016 · Synced Sep 30, 2026, 2:40 PM 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 May 1, 2026 · Synced Sep 30, 2026, 2:40 PM 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 30, 2024 · Synced Sep 30, 2026, 2:40 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 11, 2020 · Synced Sep 30, 2026, 2:40 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 20, 2020 · Synced Sep 30, 2026, 2:40 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 13, 2025 · Synced Sep 30, 2026, 2:40 PM EDT