Study to Assess the Safety, Tolerability and Pharmacokinetics of Oral Brexpiprazole (OPC- 34712) in Adolescents With Schizophrenia

April 23, 2026 updated by: Otsuka Pharmaceutical Development & Commercialization, Inc.

A Phase 1, Multicenter, Open-label, Dose-Escalation Trial to Assess the Safety, Tolerability and Pharmacokinetics of Oral Brexpiprazole (OPC- 34712) in Adolescents With Schizophrenia

The purpose of this study is to assess the safety, tolerability and pharmacokinetics (PK) of oral brexpipirazole in adolescent subjects with schizophrenia or Other Related Psychiatric Disorders.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Schizophrenia is a severely delibitating mental illness that affects approximately 1% of the world population. The onset of schizophrenia symptoms typically peaks in late adolescence and early adulthood. In a minority of cases, the initial episode may occur during childhood or early adolescence. Patients who experience this "early-onset schizophrenia" exhibit symptoms that are more severe and follow a more chronic course; adolescents with schizophrenia may never achieve full remission of the initial episode. The prognosis for early-onset schizophrenia tends to be poor, and cognitive impairment is greater compared with individuals whose onset of schizophrenia occurs later in life. Several antipsychotics have been investigated for the treatment of adolescent schizophrenia, however, there is a particular challenge because developing bodies are more sensitive to side effects of antipsychotics, particularly with respect to weight gain. In order to enroll a population that includes the younger ages, adolescents with other related psychiatric disorders are also included in this study.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
43

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arkansas
      • Little Rock, Arkansas, United States, 72211
    • California
      • Culver City, California, United States, 90230
      • Orange, California, United States, 92858
    • District of Columbia
      • Washington D.C., District of Columbia, United States, 20016
    • Georgia
      • Atlanta, Georgia, United States, 30331
    • New Jersey
      • Marlton, New Jersey, United States, 08053
    • Ohio
      • Cincinnati, Ohio, United States, 45219
      • Cleveland, Ohio, United States, 44106
    • Texas
      • The Woodlands, Texas, United States, 77381
    • Utah
      • Orem, Utah, United States, 84058

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

9 years to 13 years (Child)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Male and female subjects 13 to 17 years of age, inclusive, at the time of informed consent.
  • Subjects with a current diagnosis of primary schizophrenia spectrum or bipolar spectrum disorder, as defined by DSM-IV-TR criteria, and confirmed by K-SADS-PL.
  • No psychiatric hospitalizations within the past 12 weeks.
  • Subjects require treatment with antipsychotic medications.
  • Subjects who have received previous outpatient antipsychotic treatment at an adequate dose for an adequate duration (at least 6 weeks) and who showed a previous good response to such antipsychotic treatment (other than clozapine) in the last 12 months.
  • Subjects with a body weight at Screening greater than or equal to 30 kg.

Exclusion Criteria:

  • Sexually active females of childbearing potential and male subjects who are not practicing two different methods of birth control with their partner (or abstinence) during the trial and for 30 days after the last dose of trial medication
  • Females who are breast-feeding and/or who have a positive pregnancy test result prior to receiving trial drug.
  • Subjects who have received continuous medication therapy to treat schizophrenia and schizophrenia spectrum diagnosis for less than six months prior to first dose of study medication AND subjects who have received continuous medication therapy to treat bipolar and bipolar spectrum disorder for less than two months in the past three years; or subjects who require more than one antipsychotic..
  • Subjects with a current DSM-IV-TR diagnosis other than schizophrenia spectrum , bipolar spectrum, including any Axis I or Axis II (DSM-IV-TR) disorder.
  • Subjects with a clinical presentation and/or history of any neurodevelopmental disorder
  • Subjects who have met DSM-IV-TR criteria for substance abuse or dependence within the past 180 days.
  • Subjects who currently have clinically significant neurological, hepatic, renal, metabolic, hematological, immunological, cardiovascular, pulmonary, or gastrointestinal disorders such as any history of myocardial infarction, congestive heart failure, HIV seropositive status/acquired immunodeficiency syndrome, or chronic hepatitis B or C.
  • Subjects with IDDM (ie, any subjects using insulin) are excluded. Subjects with non-IDDM may be eligible for the trial if their condition is stable.
  • Subjects with epilepsy or a history of seizures.
  • Any major surgery or blood transfusion within 30 days prior to first dose of trial medication.
  • Subjects with a positive drug screen for cocaine or other illicit drugs, or alcohol are excluded and may not be retested or re-screened.
  • Prohibited concomitant medications used within the exclusionary period prior to Day 1 of the Dose Escalation Phase or anticipated need for such medications during the trial.
  • Subjects who participated in a clinical trial and were exposed to IMP within the last 30 days or who participated in more than two interventional clinical trials within the past year.
  • Subjects with a history of true allergic response (ie, not intolerance) to more than one class of medications.
  • Inability to tolerate oral medication or swallow tablets.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Cohort 1
0.5 mg, Brexpipraxzole (OPC-34712)
Drug: Brexpiprazole (OPC-34712)
Subjects who are deemed eligible for the trial will be assigned to a dosing cohort and will enter a Dose Titration Phase during which they will receive a starting dose of brexpiprazole for 2 to 10 days based on their assigned titration schedule. The Dose Titration Phase may be extended up to a maximum of 14 days, based on the observed safety and tolerability profile of the previous cohort's Dose Titration Phase. Following the Dose Titration Phase, subjects will enter the Fixed Dose Phase and will be administered the assigned dose for that cohort for 14 days.
Experimental: Cohort 2
1mg, Brexpipraxzole (OPC-34712)
Drug: Brexpiprazole (OPC-34712)
Subjects who are deemed eligible for the trial will be assigned to a dosing cohort and will enter a Dose Titration Phase during which they will receive a starting dose of brexpiprazole for 2 to 10 days based on their assigned titration schedule. The Dose Titration Phase may be extended up to a maximum of 14 days, based on the observed safety and tolerability profile of the previous cohort's Dose Titration Phase. Following the Dose Titration Phase, subjects will enter the Fixed Dose Phase and will be administered the assigned dose for that cohort for 14 days.
Experimental: Cohort 3
2mg, Brexpipraxzole (OPC-34712)
Drug: Brexpiprazole (OPC-34712)
Subjects who are deemed eligible for the trial will be assigned to a dosing cohort and will enter a Dose Titration Phase during which they will receive a starting dose of brexpiprazole for 2 to 10 days based on their assigned titration schedule. The Dose Titration Phase may be extended up to a maximum of 14 days, based on the observed safety and tolerability profile of the previous cohort's Dose Titration Phase. Following the Dose Titration Phase, subjects will enter the Fixed Dose Phase and will be administered the assigned dose for that cohort for 14 days.
Experimental: Cohort 4
3 mg, Brexpipraxzole (OPC-34712)
Drug: Brexpiprazole (OPC-34712)
Subjects who are deemed eligible for the trial will be assigned to a dosing cohort and will enter a Dose Titration Phase during which they will receive a starting dose of brexpiprazole for 2 to 10 days based on their assigned titration schedule. The Dose Titration Phase may be extended up to a maximum of 14 days, based on the observed safety and tolerability profile of the previous cohort's Dose Titration Phase. Following the Dose Titration Phase, subjects will enter the Fixed Dose Phase and will be administered the assigned dose for that cohort for 14 days.
Experimental: Cohort 5
4mg, Brexpipraxzole (OPC-34712)
Drug: Brexpiprazole (OPC-34712)
Subjects who are deemed eligible for the trial will be assigned to a dosing cohort and will enter a Dose Titration Phase during which they will receive a starting dose of brexpiprazole for 2 to 10 days based on their assigned titration schedule. The Dose Titration Phase may be extended up to a maximum of 14 days, based on the observed safety and tolerability profile of the previous cohort's Dose Titration Phase. Following the Dose Titration Phase, subjects will enter the Fixed Dose Phase and will be administered the assigned dose for that cohort for 14 days.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Reported Adverse Events (AEs) at 30 day Follow-Up
Time Frame: 30 day Follow-Up
30 day Follow-Up
Change from Baseline to Day 17 in Vital Signs
Time Frame: Baseline to Day 17
Baseline to Day 17
Change from Baseline to Day 17 ECGs
Time Frame: Baseline to Day 17
Baseline to Day 17
Change from Baseline to Day 17 Hematology
Time Frame: Baseline to Day 17
Baseline to Day 17
Change from Baseline to Day 14 Physical examination
Time Frame: Baseline to Day 14
Baseline to Day 14
Change from Baseline to Day 17 Body weight
Time Frame: Baseline to Day 17
Baseline to Day 17
Change from Baseline to Day 17 Serum chemistry
Time Frame: Baseline to Day 17
Including Prolactin concentrations
Baseline to Day 17
Change from Baseline to Day 17 Urinalysis
Time Frame: Baseline to Day 17
Baseline to Day 17
Maximal peak steady-state plasma concentration
Time Frame: At Day 14
At Day 14
Minimum trough steady-state plasma concentration
Time Frame: At Day 14
At Day 14
Time to maximum peak steady-state plasma concentration
Time Frame: At Day 14
At Day 14
Area under the concentration-time curve during the dosing interval at steady-state
Time Frame: At Day 14
At Day 14
Terminal elimination half-life
Time Frame: At Day 14
At Day 14
For Brex only, apparent cleanse and apparent volume of distribution
Time Frame: At Day 14
At Day 14

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Mean change in CGI-S score
Time Frame: Day -1 of Dose Titration Phase to Day 7 and Day 14 of Fixed Dose Phase
Day -1 of Dose Titration Phase to Day 7 and Day 14 of Fixed Dose Phase
Mean change in CGI-I score
Time Frame: Day 7 and Day 14
Day 7 and Day 14
Glycosylated haemoglobin [HbA1c]
Time Frame: Baseline to Day 17
Baseline to Day 17
Change from Baseline to Day 17 Adrenocorticotropic hormone [ACTH]
Time Frame: Baseline to Day 17
Baseline to Day 17
Change from Baseline to Day 17 Cortisol
Time Frame: Baseline to Day 17
Baseline to Day 17
Change from Baseline to Day 17 Thyroid stimulating hormone [TSH]
Time Frame: Baseline to Day 17
Baseline to Day 17
Change from Baseline to Day 17 Prothrombin time [PT]
Time Frame: Baseline to Day 17
Baseline to Day 17
Change from Baseline to Day 17 Activated partial thromboplastin time [aPTT]
Time Frame: Baseline to Day 17
Baseline to Day 17
Change from Baseline to Day 17 International normalized ratio [INR]
Time Frame: Baseline to Day 17
Baseline to Day 17
For subjects with a current primary schizophrenia spectrum diagnosis, mean change in Positive and Negative Syndrom Scale (PANSS)
Time Frame: Day-1 to Day 15
Day-1 to Day 15
For subjects with a current diagnosis of bipolar spectrum disorder, mean change in Young Mania Rating Scale (YMRS)
Time Frame: Day -1 to Day 15
Day -1 to Day 15

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Otsuka Pharmaceutical Development & Commercialization, Inc.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
H. Lundbeck A/S

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Eva Kohegyi, MD, Otsuka Pharmaceutical Development & Commercialization

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 30, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 2, 2015

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 8, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 28, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 23, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 331-10-233

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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