Safety and Tolerability of Open-Label Flexible-dose Brexpiprazole as Maintenance Treatment in Adolescents With Schizophrenia

Study Overview
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Brief Summary
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To further characterize the long-term safety and tolerability of brexpiprazole in adolescents with schizophrenia

Detailed Description
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This is a long-term, multicenter, open-label trial designed to examine the long-term safety and tolerability of brexpiprazole in adolescent subjects (ages 13-17) with a DSM-5 diagnosis of schizophrenia.

Official Title
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A Long-term, Multicenter, Open-label Trial to Evaluate the Safety and Tolerability of Flexible-Dose Brexpiprazole as Maintenance Treatment in Adolescents (13-17 Years Old) With Schizophrenia

Conditions
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Schizophrenia

Intervention / Treatment
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* Drug: Brexpiprazole


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male & female subjects 13-17 years of age, inclusive. Subjects who turn 18 during trial 331-10-234 are permitted in this trial. 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. Subjects who, in the investigator's judgment, require treatment with antipsychotic medication(s). Exclusion Criteria: Subjects with a DSM-5 diagnosis other than schizophrenia that has been the primary focus of treatment within 3 months of screening Subjects with a clinical presentation or history that is consistent with delirium, dementia, amnesia, or other cognitive disorders; subjects with psychotic symptoms that are better accounted for by another general medical condition(s) or direct effect of a substance (e.g., medication, illicit drug use). History of failure of clozapine treatment or response to clozapine treatment only. History of neuroleptic malignant syndrome

Ages Eligible for Study
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Minimum Age: 13 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Rollover & De-Novo<br>1-4 mg/day; Start at 0.5 mg/day, titrate and maintain between 1mg/day to max of 4 mg/day | Drug: Brexpiprazole<br>* Once daily, oral tablets<br>* Other names: OPC-34712;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency & Severity of Adverse Events (AE) [Safety] | Frequency and severity will be monitored; along with serious AEs & discontinuation from trial due to AE | Up to 24 months or early termination with a 21 day follow-up period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change from baseline and incidence of clinically significant abnormalities in clinical laboratory tests [Safety] | Abnormalities in hematology, serum chemistry [including fasting blood lipids, glucose and insulin, serum prolactin], glycosylated hemoglobin [HbA1c], creatine phosphokinase [CPK] and urinalysis) results | Up to 24 months or early termination | 
| Mean change from baseline and incidence of clinically significant abnormalities in vital signs [Safety] | Mean change from baseline in supine and standing positions will be assessed and incidence of clinically significant abnormalities | Up to 24 months or early termination with a 21 day follow-up period | 
| Weight [Safety] | Change in weight, in kilograms, will be assessed for any notable differences from baseline | Up to 24 months or early termination | 
| Height [Safety] | Change in height, in centimeters, will be assessed for any notable differences from baseline | Up to 24 months or early termination | 
| Body Mass Index (BMI) [Safety] | Measured in kilograms/meter^2 and assessed to determine any notable differences from baseline | Up to 24 months or early termination | 
| Waist Circumference [Safety] | Change in waist circumference, in centimeters will be assessed for any notable differences from baseline | Up to 24 months or early termination | 
| Changes in ECG [Safety] | Mean change from baseline will be assessed and incidence of clinically significant abnormalities | Up to 24 months or early termination | 
| Change in Abnormal Involuntary Movement Scale (AIMS) Score [Safety] | Mean change from baseline will be assessed | Up to 24 months or early termination | 
| Change in Simpson-Angus Scale (SAS) Score [Safety] | Mean change from baseline will be assessed | Up to 24 months or early termination | 
| Change in Barnes Akathisia Rating Scale (BARS) Score [Safety] | Mean change from baseline will be assessed | Up to 24 months or early termination | 
| Potential suicide events recorded on the Columbia-Suicide Severity Rating Scale (C-SSRS) [Safety] | Analysis of potential suicide events recorded with C SSRS | Up to 24 months or early termination | 
| Comprehensive psychotropic side effects as assessed by Udvalg for Kliniske Undersogelser (UKU) [Safety] | Psychotropic side effects will be assessed by UKU | Up to 24 months or early termination | 
| The frequency of symptom items from New York Assessment for Adverse Cognitive Effects of Neuropsychiatric Treatment (NY-AACENT) [Safety] | Frequency of symptom items will be assessed | Up to 24 months or early termination | 
| Change in Tanner Staging Scale Scores [Safety] | Baseline and post-baseline data will be assessed | Up to 24 months or early termination | 
| Time to discontinuation due to AE | Time to discontinue will be assessed as applicable | Up to 24 months or early termination | 
| Change in the Positive and Negative Syndrome Scale (PANSS) Total Score and PANSS Subscale Scores | Change from baseline in total score will be assessed for efficacy of drug. Positive/Negative subscale scores will be assessed for efficacy of drug. | Up to 24 months or early termination | 
| Change in Children's Global Assessment Scale (CGAS) Score | Change from baseline in CGAS will be assessed for efficacy of drug | Up to 24 months or early termination | 
| Change in Clinical Global Impression Severity (CGI-S) Score |  | Up to 24 months or early termination | 
| Change in Clinical Global Impression Improvement (CGI-I) Score |  | Up to 24 months or early termination | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Brexpiprazole, Schizophrenia