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Brexpiprazole for Adolescent Schizophrenia

Phase 3

Waitlist Available

Research Sponsored by Otsuka Pharmaceutical Development & Commercialization, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Male & female subjects 13-17 years of age, inclusive

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 24 months or early termination

Awards & highlights

Study Summary

This trial looked at the long-term safety and tolerability of brexpiprazole in adolescents with schizophrenia.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

While not explicitly listed in your information, common side effects of Brexpiprazole may include weight gain, restlessness or feeling like you need to move around (akathisia), fatigue, gastrointestinal issues, anxiety, insomnia, and headache.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 13 and 17 years old.

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I have been diagnosed with schizophrenia as per DSM-5 criteria.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 24 months or early termination

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 24 months or early termination

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 24 months or early termination for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Frequency & Severity of Adverse Events (AE) [Safety]

Secondary outcome measures

Body Mass Index (BMI) [Safety]

Change in Abnormal Involuntary Movement Scale (AIMS) Score [Safety]

Change in Barnes Akathisia Rating Scale (BARS) Score [Safety]

+16 more

Side effects data

From 2019 Phase 4 trial • 51 Patients • NCT03149991

16%

Alteration in Taste

16%

Dizziness

12%

Restlessness/Akathisia

Insomnia/Sleep disturbance

Gastric Distress

Constipation

Headache

Sedation

Dissociation/Detachment

Euphoria

Nausea

Elevated alt

Light headedness

Irritability

Irregular/Early Menses

Bi-lateral hand pain

Shakiness

Increased appetite

Hot flashes

Increased salivation post dose

Panic episode

Weight gain

Lethargy

Bruxism

Twitching of left side lower lip

Unsteadiness of gait

100%

80%

60%

40%

20%

Study treatment Arm

Brexpiprazole

Placebo

Trial Design

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Brexpiprazole

2013

Completed Phase 4

~4150

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Otsuka Pharmaceutical Development & Commercialization, Inc.Lead Sponsor

246 Previous Clinical Trials

166,753 Total Patients Enrolled

65 Trials studying Schizophrenia

18,734 Patients Enrolled for Schizophrenia

H. Lundbeck A/SIndustry Sponsor

325 Previous Clinical Trials

77,287 Total Patients Enrolled

46 Trials studying Schizophrenia

17,771 Patients Enrolled for Schizophrenia

Yuko Hirata, MD, PhDStudy DirectorOtsuka Pharmaceutical Development & Commercialization, Inc.

Media Library

Brexpiprazole Clinical Trial Eligibility Overview. Trial Name: NCT03238326 — Phase 3

Schizophrenia Clinical Trial 2023: Brexpiprazole Highlights & Side Effects. Trial Name: NCT03238326 — Phase 3

Brexpiprazole 2023 Treatment Timeline for Medical Study. Trial Name: NCT03238326 — Phase 3

Schizophrenia Research Study Groups: Rollover & De-Novo

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the Federal Drug Administration cleared Brexpiprazole for public consumption?

"Because this is a Phase 3 trial, meaning that there is evidence of efficacy as well as multiple rounds of data affirming safety, we have estimated the safety of Brexpiprazole to be a 3."

Answered by AI

Which patients would be a good fit for this particular clinical trial?

"This clinical trial is testing a new medication for schizophrenia in adolescents aged 13-17. A total of 300 participants are needed for the study."

Answered by AI

How many participants are needed for this research project?

"That is correct, the information available on clinicaltrials.gov reveals that this study is looking for more patients. This particular clinical trial was posted on 8/23/2017 and updated on 8/31/2022. They are hoping to enroll 300 patients from 2 different locations."

Answered by AI

Has Brexpiprazole been researched before in other clinical trials?

"The original clinical trials for brexpiprazole were conducted in 2017. For more information about active recruitment sites, please call 844-687-8522. To date, there have been 59 completed trials with 9 more presently active. Many of these active trials are based in Oklahoma City, Oklahoma."

Answered by AI

Does this research project restrict participation to those under 60 years old?

"This clinical trial is only for people aged 13 to 17. There are 49 other studies available for people under 18, and 178 studies for people over 65."

Answered by AI

Are we enrolling patients in this experiment right now?

"That is correct. The information available on clinicaltrials.gov indicates that this study is still recruiting participants. The trial was initially posted on 2017-08-23 and was most recently edited on 2022-08-31. The trial is enrolling 300 participants between 2 locations."

Answered by AI

Have other patients undergone this trial before?

"There have been a total of 59 clinical trials for Brexpiprazole since its first Phase 3 study in 2017. Presently, 9 of these trials are active and recruiting patients from across 14 cities and 3 countries."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2017. "Safety and Tolerability of Open-Label Flexible-dose Brexpiprazole as Maintenance Treatment in Adolescents With Schizophrenia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03238326.

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