Brexpiprazole for Adolescent Schizophrenia

Not currently recruiting at 76 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines the safety and tolerability of brexpiprazole, an antipsychotic medication, for adolescents with schizophrenia, a condition where individuals may experience hallucinations. Participants will take brexpiprazole daily to assess its effectiveness over time. The trial suits teens aged 13-17 diagnosed with schizophrenia who require antipsychotic treatment. As a Phase 3 trial, it represents the final step before FDA approval, allowing participants to contribute to the potential availability of a new treatment.

Do I have to stop taking my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. It is best to discuss this with the trial team or your doctor.

Is there any evidence suggesting that brexpiprazole is likely to be safe for adolescents with schizophrenia?

Research has shown that brexpiprazole can help reduce symptoms of schizophrenia in teenagers. In studies, it proved more effective than a placebo over six weeks. However, some teens experienced side effects. About one in five gained more weight than expected, which is important to consider for those concerned about weight gain.

Research has also focused on long-term safety. Findings suggest that brexpiprazole is generally safe for teens with schizophrenia. The FDA has already approved it for adults with different conditions, indicating a good safety record. For further questions, discussing them with a doctor is advisable. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for schizophrenia?

Brexpiprazole is unique because it is a next-generation antipsychotic that offers a new mechanism of action for treating adolescent schizophrenia. Unlike some traditional treatments that primarily block dopamine receptors, brexpiprazole acts as a partial agonist at both dopamine and serotonin receptors, potentially leading to fewer side effects and better overall tolerability. Researchers are excited about brexpiprazole because it might provide a more balanced approach to managing symptoms, offering hope for improved quality of life for young patients with this challenging condition.

What evidence suggests that brexpiprazole might be an effective treatment for adolescent schizophrenia?

Research has shown that brexpiprazole can help reduce schizophrenia symptoms in teenagers. In studies, teens taking brexpiprazole experienced fewer symptoms over six weeks compared to those who took a placebo, which contains no active medicine. A daily dose of 2-4 mg proved effective. Brexpiprazole also works well for long-term treatment, significantly reducing the chance of symptoms returning over a year. These findings suggest brexpiprazole is a promising option for managing schizophrenia in teenagers. Participants in this trial will receive brexpiprazole, starting at 0.5 mg/day and titrating to a maintenance dose between 1 mg/day and a maximum of 4 mg/day. ^{1 2 3 6 7}

Who Is on the Research Team?

Heather Guthrie, MD

Principal Investigator

Otsuka Pharmaceutical Development & Commercialization, Inc.

Are You a Good Fit for This Trial?

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 tried clozapine for my condition without success.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Citations

1. thelancet.com thelancet.com/journals/lanpsy/article/PIIS2215-0366(25)00043-4/fulltext

Efficacy and safety of brexpiprazole in adolescents with ... Brexpiprazole demonstrated statistically significantly greater reductions in the severity of schizophrenia symptoms over 6 weeks than placebo.

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40209740/

Efficacy and safety of brexpiprazole in adolescents with ... In adolescents with schizophrenia, brexpiprazole 2-4 mg/day was associated with greater reduction in symptom severity than placebo over 6 weeks.

3. sciencedirect.com sciencedirect.com/science/article/pii/S2949732924000437

Safety and Tolerability of Brexpiprazole in Adolescents ... The short-term efficacy of brexpiprazole vs placebo on schizophrenia symptoms in adolescents has been investigated in the parent phase 3 randomized controlled ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT02411695?term=NCT00805454%20NCT00905307%20NCT01289080%20NCT01299454%20NCT01393613%20NCT01396421%20NCT01397786%20NCT01423916%20NCT01451164%20NCT01456897%20NCT01649557%20NCT01668797%20NCT01810380%20NCT01810783%20NCT01854944%20NCT02013622%20NCT02054702%20NCT02194933%20NCT02411695%20NCT02758067%20NCT02968121%20NCT03198078%20NCT03238326%20NCT03557931%20NCT03874494%20NCT05119894%20NCT05325645%20NCT05326347&rank=10

Study to Assess the Safety, Tolerability and ... An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during a clinical study or within a certain amount of ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5412583/

Efficacy and Safety of Brexpiprazole (OPC-34712) as ... Brexpiprazole was found to be an efficacious maintenance therapy over the course of 1 year, reducing the risk of impending relapse by 71% vs placebo, and with ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT02411695

NCT02411695 | Study to Assess the Safety, Tolerability ... The purpose of this study is to assess the safety, tolerability and pharmacokinetics (PK) of oral brexpipirazole in adolescent subjects with schizophrenia or ...

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40520975/

Safety and Tolerability of Brexpiprazole in Adolescents ... This study aimed to characterize long-term safety and tolerability of brexpiprazole, an atypical antipsychotic, as maintenance treatment in adolescents with ...