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Showing 25–48 of 24 matching trials from the live ClinicalTrials.gov search.
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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 10, 2026, 8:12 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 10, 2026, 8:12 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 10, 2026, 8:12 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 10, 2026, 8:12 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 10, 2026, 8:12 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 10, 2026, 8:12 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 10, 2026, 8:12 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 10, 2026, 8:12 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 10, 2026, 8:12 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 10, 2026, 8:12 AM EDT
Completed Phase 3 Interventional Results available

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

NCT01360645
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
826 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2011 – 2013
U.S. locations
37
States / cities
Arcadia, California • Beverly Hills, California • Fresno, California + 34 more
Source: ClinicalTrials.gov public record
Updated Nov 25, 2015 · Synced Sep 10, 2026, 8:12 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 10, 2026, 8:12 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 10, 2026, 8:12 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 10, 2026, 8:12 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 10, 2026, 8:12 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 10, 2026, 8:12 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 10, 2026, 8:12 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 10, 2026, 8:12 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

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 9, 2020 · Synced Sep 10, 2026, 8:12 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 10, 2026, 8:12 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 10, 2026, 8:12 AM 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 12, 2025 · Synced Sep 10, 2026, 8:12 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 10, 2026, 8:12 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 10, 2026, 8:12 AM EDT