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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 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 24, 2026, 3:53 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 24, 2026, 3:53 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 24, 2026, 3:53 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 24, 2026, 3:53 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 24, 2026, 3:53 AM 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 8, 2017 · Synced Sep 24, 2026, 3:53 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 24, 2026, 3:53 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 24, 2026, 3:53 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 24, 2026, 3:53 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 24, 2026, 3:53 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 24, 2026, 3:53 AM EDT
Completed Phase 4 Interventional Results available

Controlled Trial of Brexpiprazole For The Treatment of Co-occurring Schizophrenia and Substance Use Disorder

NCT03526354
View directory record Official record
Conditions
Schizophrenia, Schizoaffective Disorder, Substance Use Disorders
Interventions
Brexpiprazole, Treatment as Usual
Drug · Other
Lead sponsor
University of Massachusetts, Worcester
Other
Eligibility
18 Years to 65 Years
Enrollment
50 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2018 – 2024
U.S. locations
4
States / cities
Augusta, Georgia • Boston, Massachusetts • Worcester, Massachusetts + 1 more
Source: ClinicalTrials.gov public record
Updated May 22, 2025 · Synced Sep 24, 2026, 3:53 AM 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 24, 2026, 3:53 AM EDT
Terminated Phase 1 Interventional

A Trial to Assess the Effects of Prazosin or Propranolol on Blood Pressure in the Presence of Brexpiprazole/Sertraline

NCT05189977
View directory record Official record
Conditions
Post-traumatic Stress Disorder (PTSD)
Interventions
Propranolol, Prazosin
Drug
Lead sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Industry
Eligibility
18 Years to 65 Years
Enrollment
34 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2022 – 2023
U.S. locations
1
States / cities
Princeton, New Jersey
Source: ClinicalTrials.gov public record
Updated Jan 22, 2024 · Synced Sep 24, 2026, 3:53 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 24, 2026, 3:53 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 24, 2026, 3:53 AM EDT
Completed Phase 3 Interventional Results available

Brexpiprazole in Patients With Schizophrenia

NCT01810783
View directory record Official record
Conditions
Schizophrenia
Interventions
Brexpiprazole
Drug
Lead sponsor
H. Lundbeck A/S
Industry
Eligibility
18 Years to 65 Years
Enrollment
210 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2013 – 2015
U.S. locations
17
States / cities
Anaheim, California • Cerritos, California • Escondido, California + 12 more
Source: ClinicalTrials.gov public record
Updated Mar 26, 2017 · Synced Sep 24, 2026, 3:53 AM 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 24, 2026, 3:53 AM EDT
Completed Phase 3 Interventional Results available

Brexpiprazole in Patients With Acute Schizophrenia

NCT01810380
View directory record Official record
Conditions
Schizophrenia
Interventions
Placebo, Brexpiprazole, Quetiapine extended release
Drug
Lead sponsor
H. Lundbeck A/S
Industry
Eligibility
18 Years to 65 Years
Enrollment
468 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2013 – 2014
U.S. locations
1
States / cities
Escondido, California
Source: ClinicalTrials.gov public record
Updated Mar 15, 2017 · Synced Sep 24, 2026, 3:53 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 24, 2026, 3:53 AM EDT
Completed Phase 3 Interventional Results available

A 12-week Extension Trial to Evaluate the Safety and Tolerability of Brexpiprazole in the Treatment of Subjects With Agitation Associated With Dementia of the Alzheimer's Type

NCT03594123
View directory record Official record
Conditions
Alzheimer's Disease
Interventions
Brexpiprazole
Drug
Lead sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Industry
Eligibility
55 Years to 91 Years
Enrollment
259 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2018 – 2022
U.S. locations
1
States / cities
Miami, Florida
Source: ClinicalTrials.gov public record
Updated Nov 13, 2023 · Synced Sep 24, 2026, 3:53 AM EDT
Completed Phase 3 Interventional Results available

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

NCT02013622
View directory record Official record
Conditions
Schizophrenia
Interventions
Brexpiprazole
Drug
Lead sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Industry
Eligibility
18 Years to 35 Years
Enrollment
49 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2013 – 2014
U.S. locations
22
States / cities
Cerritos, California • Chula Vista, California • Costa Mesa, California + 17 more
Source: ClinicalTrials.gov public record
Updated Mar 28, 2016 · Synced Sep 24, 2026, 3:53 AM EDT
Completed Phase 3 Interventional Results available

Efficacy, Safety, and Tolerability of Brexpiprazole (OPC-34712) as Maintenance Treatment in Adults With Schizophrenia

NCT01668797
View directory record Official record
Conditions
Acute Schizophrenia
Interventions
Brexpiprazole, Placebo
Drug
Lead sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Industry
Eligibility
18 Years to 65 Years
Enrollment
524 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2012 – 2015
U.S. locations
14
States / cities
Anaheim, California • Cerritos, California • Garden Grove, California + 10 more
Source: ClinicalTrials.gov public record
Updated Jan 12, 2017 · Synced Sep 24, 2026, 3:53 AM EDT
Completed Phase 2 Interventional Results available

Brexpiprazole in Borderline Personality Disorder

NCT03418675
View directory record Official record
Conditions
Borderline Personality Disorder
Interventions
Rexulti, Placebo
Drug
Lead sponsor
University of Chicago
Other
Eligibility
18 Years to 65 Years
Enrollment
80 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2018 – 2021
U.S. locations
1
States / cities
Chicago, Illinois
Source: ClinicalTrials.gov public record
Updated Mar 17, 2022 · Synced Sep 24, 2026, 3:53 AM EDT