Brexpiprazole for Adolescent Schizophrenia

Recruiting in Palo Alto (17 mi)

+2 other locations

Age: < 18

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Approved in 6 jurisdictions

Trial Summary

What is the purpose of this trial?To further characterize the long-term safety and tolerability of brexpiprazole in adolescents with schizophrenia

Eligibility Criteria

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.

Inclusion Criteria

I need antipsychotic medication as per my doctor's advice.

I am between 13 and 17 years old.

I turned 18 during trial 331-10-234.

+1 more

Exclusion Criteria

I have a mental health condition other than schizophrenia that has been my main treatment focus in the last 3 months.

I have had neuroleptic malignant syndrome in the past.

I have a history or symptoms of cognitive disorders like dementia or delirium not caused by substances or other conditions.

+1 more

Participant Groups

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.

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