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Showing 1–24 of 28 matching trials from the live ClinicalTrials.gov search.
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Filters: Intervention: Brexpiprazole (OPC-34712) Clear all
Completed Phase 3 Interventional Results available

Study of the Safety and Efficacy of Fixed-dose Brexpiprazole (OPC-34712) as Adjunctive Therapy in the Treatment of Adults With Major Depressive Disorder With and Without Anxious Distress

NCT02196506
View directory record Official record
Conditions
Depressive Disorder, Depression, Depressive Disorder, Major, Mood Disorders, Mental Disorders
Interventions
Placebo + ADT, Brexpiprazole +ADT
Drug
Lead sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Industry
Eligibility
18 Years to 65 Years
Enrollment
837 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2014 – 2016
U.S. locations
30
States / cities
Birmingham, Alabama • Beverly Hills, California • Denver, Colorado + 27 more
Source: ClinicalTrials.gov public record
Updated Aug 20, 2018 · Synced Sep 28, 2026, 6:12 PM 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 28, 2026, 6:12 PM 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 28, 2026, 6:12 PM 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 28, 2026, 6:12 PM 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 28, 2026, 6:12 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 11, 2018 · Synced Sep 28, 2026, 6:12 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 11, 2023 · Synced Sep 28, 2026, 6:12 PM 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 28, 2026, 6:12 PM EDT
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 28, 2026, 6:12 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 27, 2026 · Synced Sep 28, 2026, 6:12 PM 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 28, 2026, 6:12 PM 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 28, 2026, 6:12 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 19, 2020 · Synced Sep 28, 2026, 6:12 PM 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 28, 2026, 6:12 PM 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 28, 2026, 6:12 PM 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 28, 2026, 6:12 PM 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 28, 2026, 6:12 PM 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 28, 2026, 6:12 PM EDT
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 28, 2026, 6:12 PM 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 28, 2026, 6:12 PM 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 28, 2026, 6:12 PM 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 28, 2026, 6:12 PM 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 28, 2026, 6:12 PM 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 28, 2026, 6:12 PM EDT