Safety and Tolerability of Open-Label Flexible-dose Brexpiprazole as Maintenance Treatment in Adolescents With Schizophrenia
Study Details
Study Description
Brief Summary
To further characterize the long-term safety and tolerability of brexpiprazole in adolescents with schizophrenia
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 3 |
Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Rollover & De-Novo 1-4 mg/day; Start at 0.5 mg/day, titrate and maintain between 1mg/day to max of 4 mg/day |
Drug: Brexpiprazole
Once daily, oral tablets
Other Names:
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Outcome Measures
Primary Outcome Measures
- Frequency & Severity of Adverse Events (AE) [Safety] [Up to 24 months or early termination with a 21 day follow-up period]
Frequency and severity will be monitored; along with serious AEs & discontinuation from trial due to AE
Secondary Outcome Measures
- Mean change from baseline and incidence of clinically significant abnormalities in clinical laboratory tests [Safety] [Up to 24 months or early termination]
Abnormalities in hematology, serum chemistry [including fasting blood lipids, glucose and insulin, serum prolactin], glycosylated hemoglobin [HbA1c], creatine phosphokinase [CPK] and urinalysis) results
- Mean change from baseline and incidence of clinically significant abnormalities in vital signs [Safety] [Up to 24 months or early termination with a 21 day follow-up period]
Mean change from baseline in supine and standing positions will be assessed and incidence of clinically significant abnormalities
- Weight [Safety] [Up to 24 months or early termination]
Change in weight, in kilograms, will be assessed for any notable differences from baseline
- Height [Safety] [Up to 24 months or early termination]
Change in height, in centimeters, will be assessed for any notable differences from baseline
- Body Mass Index (BMI) [Safety] [Up to 24 months or early termination]
Measured in kilograms/meter^2 and assessed to determine any notable differences from baseline
- Waist Circumference [Safety] [Up to 24 months or early termination]
Change in waist circumference, in centimeters will be assessed for any notable differences from baseline
- Changes in ECG [Safety] [Up to 24 months or early termination]
Mean change from baseline will be assessed and incidence of clinically significant abnormalities
- Change in Abnormal Involuntary Movement Scale (AIMS) Score [Safety] [Up to 24 months or early termination]
Mean change from baseline will be assessed
- Change in Simpson-Angus Scale (SAS) Score [Safety] [Up to 24 months or early termination]
Mean change from baseline will be assessed
- Change in Barnes Akathisia Rating Scale (BARS) Score [Safety] [Up to 24 months or early termination]
Mean change from baseline will be assessed
- Potential suicide events recorded on the Columbia-Suicide Severity Rating Scale (C-SSRS) [Safety] [Up to 24 months or early termination]
Analysis of potential suicide events recorded with C SSRS
- Comprehensive psychotropic side effects as assessed by Udvalg for Kliniske Undersogelser (UKU) [Safety] [Up to 24 months or early termination]
Psychotropic side effects will be assessed by UKU
- The frequency of symptom items from New York Assessment for Adverse Cognitive Effects of Neuropsychiatric Treatment (NY-AACENT) [Safety] [Up to 24 months or early termination]
Frequency of symptom items will be assessed
- Change in Tanner Staging Scale Scores [Safety] [Up to 24 months or early termination]
Baseline and post-baseline data will be assessed
- Time to discontinuation due to AE [Up to 24 months or early termination]
Time to discontinue will be assessed as applicable
- Change in the Positive and Negative Syndrome Scale (PANSS) Total Score and PANSS Subscale Scores [Up to 24 months or early termination]
Change from baseline in total score will be assessed for efficacy of drug. Positive/Negative subscale scores will be assessed for efficacy of drug.
- Change in Children's Global Assessment Scale (CGAS) Score [Up to 24 months or early termination]
Change from baseline in CGAS will be assessed for efficacy of drug
- 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]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Male & female subjects 13-17 years of age, inclusive.
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Subjects who turn 18 during trial 331-10-234 are permitted in this trial.
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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.
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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).
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History of failure of clozapine treatment or response to clozapine treatment only.
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History of neuroleptic malignant syndrome
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | For additional information regarding sites, contact 844-687-8522 | Oklahoma City | Oklahoma | United States | 73116 |
Sponsors and Collaborators
- Otsuka Pharmaceutical Development & Commercialization, Inc.
- H. Lundbeck A/S
Investigators
- Study Director: Caroline Ward, PhD., Otsuka Pharmaceutical Development & Commercialization, Inc.
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 331-10-236