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ClinicalTrials.gov public records Last synced Oct 20, 2026, 3:30 PM EDT

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Showing 1–24 of 37 matching trials from the live ClinicalTrials.gov search.
Filters: Intervention: OPC-34712 Clear all
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 26, 2015 · Synced Oct 20, 2026, 3:30 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 8, 2018 · Synced Oct 20, 2026, 3:30 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 18, 2023 · Synced Oct 20, 2026, 3:30 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 31, 2020 · Synced Oct 20, 2026, 3:30 PM EDT
Completed Phase 3 Interventional Results available

Efficacy Study of OPC-34712 in Adults With Acute Schizophrenia

NCT01393613
View directory record Official record
Conditions
Acute Schizophrenia
Interventions
OPC-34712, Placebo
Drug
Lead sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Industry
Eligibility
18 Years to 65 Years
Enrollment
674 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2011 – 2014
U.S. locations
19
States / cities
Little Rock, Arkansas • Springdale, Arkansas • Escondido, California + 15 more
Source: ClinicalTrials.gov public record
Updated Nov 26, 2015 · Synced Oct 20, 2026, 3:30 PM 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 30, 2024 · Synced Oct 20, 2026, 3:30 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 28, 2026 · Synced Oct 20, 2026, 3:30 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 12, 2018 · Synced Oct 20, 2026, 3:30 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 Jan 1, 2016 · Synced Oct 20, 2026, 3:30 PM EDT
Completed Phase 3 Interventional Results available

Safety and Tolerability Study of Oral OPC-34712 as Maintenance Treatment in Adults With Schizophrenia

NCT01397786
View directory record Official record
Conditions
Schizophrenia
Interventions
OPC-34712
Drug
Lead sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Industry
Eligibility
18 Years to 65 Years
Enrollment
1,044 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2011 – 2016
U.S. locations
56
States / cities
Birmingham, Alabama • Little Rock, Arkansas • Springdale, Arkansas + 46 more
Source: ClinicalTrials.gov public record
Updated May 10, 2017 · Synced Oct 20, 2026, 3:30 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 2, 2023 · Synced Oct 20, 2026, 3:30 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 29, 2015 · Synced Oct 20, 2026, 3:30 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 28, 2025 · Synced Oct 20, 2026, 3:30 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 20, 2023 · Synced Oct 20, 2026, 3:30 PM EDT
Completed Phase 1 Interventional Accepts healthy volunteers Results available

Trial Evaluating OPC-34712 in Subjects With Normal Renal Function and Renally Impaired Subjects

NCT01289080
View directory record Official record
Conditions
Schizophrenia, Psychiatric Disorders
Interventions
OPC-34712
Drug
Lead sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Industry
Eligibility
18 Years and older
Enrollment
19 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2011 – 2012
U.S. locations
2
States / cities
Miami, Florida • Minneapolis, Minnesota
Source: ClinicalTrials.gov public record
Updated Oct 29, 2015 · Synced Oct 20, 2026, 3:30 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 20, 2020 · Synced Oct 20, 2026, 3:30 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 4, 2026 · Synced Oct 20, 2026, 3:30 PM EDT
Completed Phase 1 Interventional Accepts healthy volunteers Results available

A Study Evaluating the of OPC-34712 in Subjects With Normal Hepatic Function and Hepatically Impaired Subjects

NCT01299454
View directory record Official record
Conditions
Schizophrenia
Interventions
OPC-34712
Drug
Lead sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Industry
Eligibility
18 Years and older
Enrollment
45 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2010 – 2011
U.S. locations
3
States / cities
Miami, Florida • Minneapolis, Minnesota • San Antonio, Texas
Source: ClinicalTrials.gov public record
Updated Oct 20, 2015 · Synced Oct 20, 2026, 3:30 PM EDT
Completed Phase 2 Interventional Results available

Study to Evaluate the Efficacy, Safety, and Tolerability of Oral OPC-34712 and Aripiprazole for Treatment of Acute Schizophrenia

NCT00905307
View directory record Official record
Conditions
Schizophrenia
Interventions
OPC-34712, Placebo, Aripiprazole
Drug
Lead sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Industry
Eligibility
18 Years to 65 Years
Enrollment
459 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2009 – 2010
U.S. locations
16
States / cities
Little Rock, Arkansas • Escondido, California • Garden Grove, California + 12 more
Source: ClinicalTrials.gov public record
Updated Oct 20, 2015 · Synced Oct 20, 2026, 3:30 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 17, 2020 · Synced Oct 20, 2026, 3:30 PM EDT
Completed Phase 2 Interventional Results available

Study of the Safety and Efficacy of OPC-34712 as Adjunctive Therapy in the Treatment of Adults With Major Depressive Disorder

NCT01052077
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
773 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2010 – 2011
U.S. locations
43
States / cities
Birmingham, Alabama • Arcadia, California • Beverly Hills, California + 39 more
Source: ClinicalTrials.gov public record
Updated Nov 2, 2015 · Synced Oct 20, 2026, 3:30 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 8, 2018 · Synced Oct 20, 2026, 3:30 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 12, 2023 · Synced Oct 20, 2026, 3:30 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 17, 2018 · Synced Oct 20, 2026, 3:30 PM EDT