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Brexpiprazole for Adolescent Schizophrenia

Phase 3
Waitlist Available
Research Sponsored by Otsuka Pharmaceutical Development & Commercialization, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Male & female subjects 13-17 years of age, inclusive
Subjects with a current primary diagnosis of schizophrenia, as defined by Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) criteria and confirmed by the K-SADS-PL completed at time of entry into Trial 331-10-234. For de novo subjects who did not participate in Trial 331-10-234, the initial diagnosis of schizophrenia must be made and documented, and the diagnosis confirmed by the K-SADS-PL at screening
Must not have
History of neuroleptic malignant syndrome
History of failure of clozapine treatment or response to clozapine treatment only
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 24 months or early termination
Awards & highlights
No Placebo-Only Group
Pivotal Trial

Summary

This trial looked at the long-term safety and tolerability of brexpiprazole in adolescents with schizophrenia.

Who is the study for?
Adolescents aged 13-17 with a diagnosis of schizophrenia can join this trial. Those who turn 18 during the trial may continue participating. Candidates must need antipsychotic treatment, as judged by an investigator, and have their condition confirmed through specific diagnostic criteria.
What is being tested?
The trial is testing the long-term safety and tolerability of Brexpiprazole when used as a maintenance treatment for adolescents with schizophrenia to understand how well they handle the medication over time.
What are the potential side effects?
While not explicitly listed in your information, common side effects of Brexpiprazole may include weight gain, restlessness or feeling like you need to move around (akathisia), fatigue, gastrointestinal issues, anxiety, insomnia, and headache.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 13 and 17 years old.
Select...
I have been diagnosed with schizophrenia as per DSM-5 criteria.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have had neuroleptic malignant syndrome in the past.
Select...
I have tried clozapine for my condition without success.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 24 months or early termination
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 24 months or early termination for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Frequency & Severity of Adverse Events (AE) [Safety]
Secondary study objectives
Body Mass Index (BMI) [Safety]
Change in Abnormal Involuntary Movement Scale (AIMS) Score [Safety]
Change in Barnes Akathisia Rating Scale (BARS) Score [Safety]
+14 more

Side effects data

From 2019 Phase 4 trial • 51 Patients • NCT03149991
16%
Dizziness
16%
Alteration in Taste
12%
Restlessness/Akathisia
8%
Headache
8%
Dissociation/Detachment
8%
Insomnia/Sleep disturbance
8%
Sedation
8%
Constipation
8%
Gastric Distress
4%
Elevated alt
4%
Hot flashes
4%
Unsteadiness of gait
4%
Lethargy
4%
Increased appetite
4%
Twitching of left side lower lip
4%
Light headedness
4%
Panic episode
4%
Shakiness
4%
Irritability
4%
Increased salivation post dose
4%
Weight gain
4%
Bruxism
4%
Nausea
4%
Bi-lateral hand pain
4%
Euphoria
4%
Irregular/Early Menses
100%
80%
60%
40%
20%
0%
Study treatment Arm
Brexpiprazole
Placebo

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Rollover & De-NovoExperimental Treatment1 Intervention
1-4 mg/day; Start at 0.5 mg/day, titrate and maintain between 1mg/day to max of 4 mg/day
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Brexpiprazole
2013
Completed Phase 4
~4040

Find a Location

Who is running the clinical trial?

Otsuka Pharmaceutical Development & Commercialization, Inc.Lead Sponsor
266 Previous Clinical Trials
168,816 Total Patients Enrolled
81 Trials studying Schizophrenia
21,599 Patients Enrolled for Schizophrenia
H. Lundbeck A/SIndustry Sponsor
331 Previous Clinical Trials
77,897 Total Patients Enrolled
46 Trials studying Schizophrenia
17,771 Patients Enrolled for Schizophrenia
Heather Guthrie, MDStudy DirectorOtsuka Pharmaceutical Development & Commercialization, Inc.
Yuko Hirata, MD, PhDStudy DirectorOtsuka Pharmaceutical Development & Commercialization, Inc.
Caroline Ward, PhD.Study DirectorOtsuka Pharmaceutical Development & Commercialization, Inc.
1 Previous Clinical Trials
316 Total Patients Enrolled
1 Trials studying Schizophrenia
316 Patients Enrolled for Schizophrenia

Media Library

Brexpiprazole Clinical Trial Eligibility Overview. Trial Name: NCT03238326 — Phase 3
Schizophrenia Clinical Trial 2023: Brexpiprazole Highlights & Side Effects. Trial Name: NCT03238326 — Phase 3
Brexpiprazole 2023 Treatment Timeline for Medical Study. Trial Name: NCT03238326 — Phase 3
Schizophrenia Research Study Groups: Rollover & De-Novo
~13 spots leftby May 2025
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