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Showing 25–48 of 24 matching trials from the live ClinicalTrials.gov search.
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Filters: Intervention: Brexpiprazole Clear all
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 25, 2026, 2:16 AM 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 25, 2026, 2:16 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 25, 2026, 2:16 AM EDT
Completed Phase 3 Interventional Results available

Safety and Tolerability of Oral OPC-34712 as Adjunctive Therapy in Adults With Major Depressive Disorder (the Orion Trial)

NCT01360866
View directory record Official record
Conditions
Depressive Disorder, Depression, Depressive Disorder, Major, Mood Disorders, Mental Disorders
Interventions
OPC-34712, Escitalopram, Fluoxetine, Paroxetine CR, Sertraline, Duloxetine, Venlafaxine XR
Drug
Lead sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Industry
Eligibility
18 Years to 65 Years
Enrollment
2,944 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2011 – 2017
U.S. locations
93
States / cities
Birmingham, Alabama • Phoenix, Arizona • Little Rock, Arkansas + 90 more
Source: ClinicalTrials.gov public record
Updated Sep 16, 2018 · Synced Sep 25, 2026, 2:16 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 25, 2026, 2:16 AM EDT
Completed Phase 3 Interventional Results available

Monotherapy Brexpiprazole (OPC-34712) Trial in the Treatment of Adults With Schizophrenia With Impulsivity

NCT02194933
View directory record Official record
Conditions
Schizophrenia With Impulsivity
Interventions
Brexpiprazole
Drug
Lead sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Industry
Eligibility
18 Years to 65 Years
Enrollment
38 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2015 – 2016
U.S. locations
1
States / cities
Orange, California
Source: ClinicalTrials.gov public record
Updated Nov 7, 2018 · Synced Sep 25, 2026, 2:16 AM 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 12, 2017 · Synced Sep 25, 2026, 2:16 AM EDT
Terminated Phase 2 Interventional Results available

A Pilot Dose-Response Biomarker Study of Brexpiprazole Treatment in PTSD

NCT02934932
View directory record Official record
Conditions
Post Traumatic Stress Disorder
Interventions
Brexpiprazole
Drug
Lead sponsor
Duke University
Other
Eligibility
18 Years to 65 Years
Enrollment
15 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2017 – 2018
U.S. locations
1
States / cities
Durham, North Carolina
Source: ClinicalTrials.gov public record
Updated Mar 4, 2019 · Synced Sep 25, 2026, 2:16 AM EDT
Completed Phase 3 Interventional Results available

Study of the Effectiveness of Three Different Doses of OPC-34712 in the Treatment of Adults With Acute Schizophrenia

NCT01396421
View directory record Official record
Conditions
Acute Schizophrenia
Interventions
OPC-34712 [Brexpiprazole] High Dose, Experimental: OPC-34712 [Brexpiprazole] Middle Dose, Experimental: OPC-34712 [Brexpiprazole] Low Dose, Placebo
Drug
Lead sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Industry
Eligibility
18 Years to 65 Years
Enrollment
636 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2011 – 2014
U.S. locations
17
States / cities
Little Rock, Arkansas • Garden Grove, California • Glendale, California + 12 more
Source: ClinicalTrials.gov public record
Updated Oct 28, 2015 · Synced Sep 25, 2026, 2:16 AM EDT
Completed Phase 3 Interventional Results available

Safety and Tolerability of Open-Label Flexible-dose Brexpiprazole as Maintenance Treatment in Adolescents With Schizophrenia

NCT03238326
View directory record Official record
Conditions
Schizophrenia
Interventions
Brexpiprazole
Drug
Lead sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Industry
Eligibility
13 Years to 17 Years
Enrollment
295 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2017 – 2025
U.S. locations
17
States / cities
Dothan, Alabama • Anaheim, California • Culver City, California + 14 more
Source: ClinicalTrials.gov public record
Updated Feb 3, 2026 · Synced Sep 25, 2026, 2:16 AM EDT
Completed Phase 3 Interventional Results available

Brexpiprazole as Adjunctive Therapy With Major Depressive Disorder and an Inadequate Response to Previous Adjunctive Therapy

NCT02012218
View directory record Official record
Conditions
Major Depressive Disorder (MDD)
Interventions
ADT, Brexpiprazole
Drug
Lead sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Industry
Eligibility
18 Years to 65 Years
Enrollment
61 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2013 – 2014
U.S. locations
24
States / cities
Garden Grove, California • Temecula, California • Orlando, Florida + 21 more
Source: ClinicalTrials.gov public record
Updated Dec 28, 2015 · Synced Sep 25, 2026, 2:16 AM 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 25, 2026, 2:16 AM EDT
Completed Phase 3 Interventional Results available

Study of the Safety and Efficacy of Two Fixed Doses of OPC-34712 as Adjunctive Therapy in the Treatment of Adults With Major Depressive Disorder (the Polaris Trial)

NCT01360632
View directory record Official record
Conditions
Depressive Disorder, Depression, Depressive Disorder, Major, Mood Disorders, Mental Disorders
Interventions
OPC-34712 + ADT, Placebo + ADT
Drug
Lead sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Industry
Eligibility
18 Years to 65 Years
Enrollment
1,539 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2011 – 2013
U.S. locations
52
States / cities
Birmingham, Alabama • Costa Mesa, California • Glendale, California + 49 more
Source: ClinicalTrials.gov public record
Updated Dec 31, 2015 · Synced Sep 25, 2026, 2:16 AM EDT
Completed No phase listed Observational

Safety Follow-up Study for Subjects With Agitation Associated With Dementia of the Alzheimer's Type Who Previously Participated in a Double-blind Trial of Brexpiprazole or Placebo

NCT02192554
View directory record Official record
Conditions
Agitation Associated With Alzheimer's Disease, Alzheimer's Type, Mental Disorder, Nervous System Diseases
Interventions
Not listed
Lead sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Industry
Eligibility
Not listed
Enrollment
450 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2014 – 2017
U.S. locations
28
States / cities
Tuscaloosa, Alabama • Costa Mesa, California • Lakewood, California + 21 more
Source: ClinicalTrials.gov public record
Updated Apr 29, 2018 · Synced Sep 25, 2026, 2:16 AM 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 25, 2026, 2:16 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 25, 2026, 2:16 AM EDT
Recruiting No phase listed Observational Accepts healthy volunteers

National Pregnancy Registry for Psychiatric Medications

NCT01246765
View directory record Official record
Conditions
Pregnant Women, Psychotropic Drugs
Interventions
Not listed
Lead sponsor
Massachusetts General Hospital
Other
Eligibility
18 Years to 45 Years · Female only
Enrollment
5,000 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2008 – 2033
U.S. locations
1
States / cities
Boston, Massachusetts
Source: ClinicalTrials.gov public record
Updated Oct 23, 2025 · Synced Sep 25, 2026, 2:16 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 25, 2026, 2:16 AM EDT
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 25, 2026, 2:16 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 25, 2026, 2:16 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 25, 2026, 2:16 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 25, 2026, 2:16 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 25, 2026, 2:16 AM 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 16, 2018 · Synced Sep 25, 2026, 2:16 AM EDT