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Atypical Antipsychotic

Brexpiprazole (OPC-34712) for 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

Summary

This trial will test if the drug brexpiprazole is safe and effective in treating adolescents with schizophrenia.

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)
This trial's timeline: 3 weeks for screening, Varies for treatment, and from the first dose of study drug up to 21 days after the last dose of study drug (up to approximately 9 weeks) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change From Baseline to Week 6 in Positive and Negative Syndrome Scale (PANSS) Total Score
Secondary outcome measures
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 more

Side effects data

From 2023 Phase 3 trial • 316 Patients • NCT03198078
6%
Headache
6%
Nausea
5%
Somnolence
4%
Akathisia
2%
Fatigue
1%
Schizophrenia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Brexpiprazole
Aripiprazole
Placebo

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
327 Previous Clinical Trials
77,385 Total Patients Enrolled
46 Trials studying Schizophrenia
17,751 Patients Enrolled for Schizophrenia
Otsuka Pharmaceutical Development & Commercialization, Inc.Lead Sponsor
246 Previous Clinical Trials
166,853 Total Patients Enrolled
65 Trials studying Schizophrenia
18,714 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
~39 spots leftby Jul 2025