Brexpiprazole for Adolescent Schizophrenia

Recruiting at 59 trial locations

Overseen By Otsuka Call Center

Age: < 18

Sex: Any

Trial Phase: Phase 3

Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.

Must be taking: Antipsychotics

Disqualifiers: Delirium, Dementia, Amnesia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 6 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 24 months

295 Participants Needed

Trial Summary

What is the purpose of this trial?

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

Research Team

Heather Guthrie, MD

Principal Investigator

Otsuka Pharmaceutical Development & Commercialization, Inc.

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.

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive flexible-dose Brexpiprazole as maintenance treatment, starting at 0.5 mg/day and titrating to a maximum of 4 mg/day

Up to 24 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 weeks

Open-label extension

Participants may continue receiving Brexpiprazole to further assess long-term safety and tolerability

Long-term

Treatment Details

Interventions

• Brexpiprazole

Trial Overview 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.

Participant Groups

Group I: Rollover & De-Novo Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

Otsuka Pharmaceutical Development & Commercialization, Inc.

Lead Sponsor

Trials

271

Recruited

170,000+

John Kraus

Otsuka Pharmaceutical Development & Commercialization, Inc.

Chief Medical Officer since 2023

MD, PhD

Tarek Rabah

Otsuka Pharmaceutical Development & Commercialization, Inc.

Chief Executive Officer since 2022

BS in Biology and BA in Business from the American University of Beirut, MBA from McGill University

H. Lundbeck A/S

Industry Sponsor

Trials

332

Recruited

78,300+

Charl van Zyl

H. Lundbeck A/S

Chief Executive Officer since 2023

Degree in Medical Biochemistry from the University of Cape Town, South Africa

Johan Luthman

H. Lundbeck A/S

Chief Medical Officer since 2019

MD from the University of Gothenburg, Sweden