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Showing 1–24 of 57 matching trials from the live ClinicalTrials.gov search.
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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 2, 2026, 10:04 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 2, 2026, 10:04 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 2, 2026, 10:04 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 2, 2026, 10:04 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 2, 2026, 10:04 AM EDT
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 2, 2026, 10:04 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, 10:04 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 2, 2026, 10:04 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 2, 2026, 10:04 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, 10:04 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, 10:04 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, 10:04 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 2, 2026, 10:04 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 2, 2026, 10:04 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 2, 2026, 10:04 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, 10:04 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 2, 2026, 10:04 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 2, 2026, 10:04 AM EDT
Completed Phase 3 Interventional Results available

Brexpiprazole (OPC-34712) as an Adjunctive Treatment in Active Adults, 18 to 35 Years Old, With Major Depressive Disorder Who Are in a School or Work Environment

NCT02013609
View directory record Official record
Conditions
MDD
Interventions
Brexpiprazole
Drug
Lead sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Industry
Eligibility
18 Years to 35 Years
Enrollment
48 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2013 – 2014
U.S. locations
24
States / cities
Cerritos, California • Costa Mesa, California • Garden Grove, California + 21 more
Source: ClinicalTrials.gov public record
Updated Mar 28, 2016 · Synced Sep 2, 2026, 10:04 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 2, 2026, 10:04 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, 10:04 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, 10:04 AM EDT
Terminated Phase 1 Interventional

Safety and Tolerability Study of Single-dose Administration of Brexpiprazole in Adult Subjects With Schizophrenia

NCT02968121
View directory record Official record
Conditions
Schizophrenia
Interventions
Brexpiprazole, OPDC-34712
Drug
Lead sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Industry
Eligibility
18 Years to 64 Years
Enrollment
22 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2017
U.S. locations
2
States / cities
Garden Grove, California • San Diego, California
Source: ClinicalTrials.gov public record
Updated Jan 11, 2018 · Synced Sep 2, 2026, 10:04 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, 10:04 AM EDT