Brexpiprazole for Adolescent Schizophrenia
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.12345Why 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.12367
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive flexible-dose Brexpiprazole as maintenance treatment, starting at 0.5 mg/day and titrating to a maximum of 4 mg/day
Follow-up
Participants are monitored for safety and effectiveness after treatment
Open-label extension
Participants may continue receiving Brexpiprazole to further assess long-term safety and tolerability
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?
1
Treatment groups
Experimental Treatment
1-4 mg/day; Start at 0.5 mg/day, titrate and maintain between 1mg/day to max of 4 mg/day
Find a Clinic Near You
Who Is Running the Clinical Trial?
Otsuka Pharmaceutical Development & Commercialization, Inc.
Lead Sponsor
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
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
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.
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.
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 ...
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 ...
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 ...
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 ...
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 ...
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