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Atypical Antipsychotic
Trial to Evaluate the Short-term Safety & Efficacy of Brexpiprazole Monotherapy in the Treatment of Adolescents With 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
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from the first dose of study drug up to 21 days after the last dose of study drug (up to approximately 9 weeks)
Awards & highlights
Pivotal Trial
Summary
This trial is testing the safety and effectiveness of using the drug brexpiprazole to treat teenagers with schizophrenia. Brexpiprazole has been shown to be safe and effective in the treatment of elderly Japanese patients with schizophrenia.
Eligible Conditions
- Schizophrenia
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from the first dose of study drug up to 21 days after the last dose of study drug (up to approximately 9 weeks)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from the first dose of study drug up to 21 days after the last dose of study drug (up to approximately 9 weeks)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change From Baseline to Week 6 in Positive and Negative Syndrome Scale (PANSS) Total Score
Secondary study objectives
Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Total Score
Change From Baseline in Barnes Akathisia Rating Scale (BARS) Score
Change From Baseline in Simpson Angus Scale (SAS) Total Score
+18 moreSide effects data
From 2023 Phase 3 trial • 316 Patients • NCT031980786%
Nausea
6%
Headache
5%
Somnolence
4%
Akathisia
2%
Fatigue
1%
Schizophrenia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Brexpiprazole
Aripiprazole
Placebo
Awards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
3Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: BrexpiprazoleExperimental Treatment1 Intervention
Participants were administered with brexpiprazole oral tablets, daily, dose titrated up to 0.5 mg by Day 4, 1 mg by Day 7, 2 mg by Day 14, then between 2-4 mg after Day 21 up to Week 6 with a 1 mg increase or decrease, based on the Investigator's decision.
Group II: AripiprazoleActive Control1 Intervention
Participants were administered with aripiprazole oral tablets, daily, dose titrated up to 2 mg by Day 4, 5 mg by Day 7, 10 mg by Day 14, then 10, 15 or 20 mg after Day 21 up to Week 6 with a 5 mg increase or decrease, based on the Investigator's decision.
Group III: PlaceboPlacebo Group1 Intervention
Participants were administered with brexpiprazole or aripiprazole matching placebo oral tablets, daily up to Week 6.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Brexpiprazole (OPC-34712)
2017
Completed Phase 3
~360
Find a Location
Who is running the clinical trial?
H. Lundbeck A/SIndustry Sponsor
331 Previous Clinical Trials
77,891 Total Patients Enrolled
46 Trials studying Schizophrenia
17,751 Patients Enrolled for Schizophrenia
Otsuka Pharmaceutical Development & Commercialization, Inc.Lead Sponsor
265 Previous Clinical Trials
168,782 Total Patients Enrolled
81 Trials studying Schizophrenia
21,579 Patients Enrolled for Schizophrenia
Caroline Ward, PhD.Study DirectorOtsuka Pharmaceutical Development & Commercialization, Inc.
1 Previous Clinical Trials
296 Total Patients Enrolled
1 Trials studying Schizophrenia
296 Patients Enrolled for Schizophrenia