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SchizophreniaPhase 1NCT02411695

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

A Phase 1 study testing Brexpiprazole (OPC-34712) in people with Schizophrenia, run by Otsuka Pharmaceutical Development & Commercialization, Inc. at 10 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 13 to 17 years
Conditions the study is for
Schizophrenia
What is being tested?
Brexpiprazole (OPC-34712)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
43 participants
Where
10 sitesUnited States
Study dates
Mar 2015to 1 Jan 2017
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 13 to 17 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 15Show fewer
  • 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.

Trial locations and contacts

10 sites in 1 country.

10 sites in 1 country

United States10 sites

  • Study site

    Atlanta, Georgia, 30331

  • Study site

    Cincinnati, Ohio, 45219

  • Study site

    Cleveland, Ohio, 44106

  • Study site

    Culver City, California, 90230

  • Study site

    Little Rock, Arkansas, 72211

  • Study site

    Marlton, New Jersey, 08053

  • Study site

    Orange, California, 92858

  • Study site

    Orem, Utah, 84058

  • Study site

    The Woodlands, Texas, 77381

  • Study site

    Washington D.C., District of Columbia, 20016

Other trials in United States

About this study

Official title: 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.

Read the 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.

Conditions
Schizophrenia
Being tested
Brexpiprazole (OPC-34712)
Keywords
Adolescent, Otsuka,, Brexpiprazole
Medical subject headings
Schizophrenia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Brexpiprazole (OPC-34712)Drug

    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.

Study groups in NCT02411695
Study groupRoleWhat they receive
Cohort 1Experimental0.5 mg, Brexpipraxzole (OPC-34712)
Receives: Drug: Brexpiprazole (OPC-34712)
Cohort 2Experimental1mg, Brexpipraxzole (OPC-34712)
Receives: Drug: Brexpiprazole (OPC-34712)
Cohort 3Experimental2mg, Brexpipraxzole (OPC-34712)
Receives: Drug: Brexpiprazole (OPC-34712)
Cohort 4Experimental3 mg, Brexpipraxzole (OPC-34712)
Receives: Drug: Brexpiprazole (OPC-34712)
Cohort 5Experimental4mg, Brexpipraxzole (OPC-34712)
Receives: Drug: Brexpiprazole (OPC-34712)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Reported Adverse Events (AEs) at 30 day Follow-Up

    Measured: 30 day Follow-Up

  2. Change from Baseline to Day 17 in Vital Signs

    Measured: Baseline to Day 17

  3. Change from Baseline to Day 17 ECGs

    Measured: Baseline to Day 17

  4. Change from Baseline to Day 17 Hematology

    Measured: Baseline to Day 17

  5. Change from Baseline to Day 14 Physical examination

    Measured: Baseline to Day 14

  6. Change from Baseline to Day 17 Body weight

    Measured: Baseline to Day 17

  7. Change from Baseline to Day 17 Serum chemistry

    Including Prolactin concentrations

    Measured: Baseline to Day 17

  8. Change from Baseline to Day 17 Urinalysis

    Measured: Baseline to Day 17

  9. Maximal peak steady-state plasma concentration

    Measured: At Day 14

  10. Minimum trough steady-state plasma concentration

    Measured: At Day 14

  11. Time to maximum peak steady-state plasma concentration

    Measured: At Day 14

  12. Area under the concentration-time curve during the dosing interval at steady-state

    Measured: At Day 14

  13. Terminal elimination half-life

    Measured: At Day 14

  14. For Brex only, apparent cleanse and apparent volume of distribution

    Measured: At Day 14

Secondary outcomes (11)

  1. Mean change in CGI-S score

    Measured: Day -1 of Dose Titration Phase to Day 7 and Day 14 of Fixed Dose Phase

  2. Mean change in CGI-I score

    Measured: Day 7 and Day 14

  3. Glycosylated haemoglobin [HbA1c]

    Measured: Baseline to Day 17

  4. Change from Baseline to Day 17 Adrenocorticotropic hormone [ACTH]

    Measured: Baseline to Day 17

  5. Change from Baseline to Day 17 Cortisol

    Measured: Baseline to Day 17

  6. Change from Baseline to Day 17 Thyroid stimulating hormone [TSH]

    Measured: Baseline to Day 17

  7. Change from Baseline to Day 17 Prothrombin time [PT]

    Measured: Baseline to Day 17

  8. Change from Baseline to Day 17 Activated partial thromboplastin time [aPTT]

    Measured: Baseline to Day 17

  9. Change from Baseline to Day 17 International normalized ratio [INR]

    Measured: Baseline to Day 17

  10. For subjects with a current primary schizophrenia spectrum diagnosis, mean change in Positive and Negative Syndrom Scale (PANSS)

    Measured: Day-1 to Day 15

  11. For subjects with a current diagnosis of bipolar spectrum disorder, mean change in Young Mania Rating Scale (YMRS)

    Measured: Day -1 to Day 15

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Apr 2015 (estimated)
  2. Study startMar 2015
  3. Primary completion1 Jan 2017
  4. Study completion1 Jan 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
43 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02411695
Sponsor's protocol ID
331-10-233
Status last verified
Apr 2026
First submitted
30 May 2014
Last updated
28 Apr 2026
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Brexpiprazole (OPC-34712) in people with Schizophrenia, run by Otsuka Pharmaceutical Development & Commercialization, Inc. at 10 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Reported Adverse Events (AEs) at 30 day Follow-Up (time frame: 30 day Follow-Up). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02411695.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2026.

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