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

Otsuka

Status and phase: Completed; Phase 3

Conditions: Schizophrenia

Treatments: Drug: Brexpiprazole

Study type: Interventional

Funder types: Industry

Identifiers

NCT03238326

331-10-236

Details and patient eligibility

About

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

Full description

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

Enrollment: 295 patients

Sex: All

Ages: 13 to 17 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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295 participants in 5 patient groups

De Novo (Conversion Period)

Experimental group

Description:

1-3 milligrams/day (mg/day) brexpiprazole for 1 to 4 weeks

Treatment:

Drug: Brexpiprazole

Prior and Current Brexpiprazole (Open-label Treatment Period)

Experimental group

Description:

1-4 mg/day brexpiprazole; Start at 0.5 mg/day, titrate and maintain between 1mg/day to max of 4 mg/day

Treatment:

Drug: Brexpiprazole

Prior Aripiprazole and Current Brexpiprazole (Open-label Treatment Period)

Experimental group

Description:

1-4 mg/day brexpiprazole; Start at 0.5 mg/day, titrate and maintain between 1mg/day to max of 4 mg/day

Treatment:

Drug: Brexpiprazole

Prior Placebo and Current Brexpiprazole (Open-label Treatment Period)

Experimental group

Description:

1-4 mg/day brexpiprazole; Start at 0.5 mg/day, titrate and maintain between 1mg/day to max of 4 mg/day

Treatment:

Drug: Brexpiprazole

De Novo (Open-label Treatment Period)

Experimental group

Description:

1-4 mg/day brexpiprazole; Start at 0.5 mg/day, titrate and maintain between 1mg/day to max of 4 mg/day

Treatment:

Drug: Brexpiprazole