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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

Study 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%
Nausea
6%
Headache
5%
Somnolence
4%
Akathisia
2%
Fatigue
1%
Schizophrenia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
Brexpiprazole
Aripiprazole

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
325 Previous Clinical Trials
77,267 Total Patients Enrolled
46 Trials studying Schizophrenia
17,751 Patients Enrolled for Schizophrenia
Otsuka Pharmaceutical Development & Commercialization, Inc.Lead Sponsor
245 Previous Clinical Trials
166,679 Total Patients Enrolled
64 Trials studying Schizophrenia
18,660 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

Frequently Asked Questions

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

Is the age limit for this trial set at 40 years or older?

"As this study's inclusion criteria demonstrates, the youngest patients that can take part in this trial are 13 years old while the oldest participants can be 17."

Answered by AI

Could you give me the screening criteria for this clinical trial?

"The target recruitment for this clinical trial investigating a new medication for adolescents with schizophrenia is 315 patients. The ages of the patients must be between 13-17 and they must have a current PANSS score that is >= 80."

Answered by AI

Can patients still enroll in this research project?

"This clinical trial, which was first posted on 2017-06-30, is looking for participants as of the most recent update on 2022-08-31."

Answered by AI

What similar research has been conducted on Brexpiprazole (OPC-34712)?

"As of now, there are 10 Phase 3 trials and 19 total live studies for Brexpiprazole (OPC-34712). The majority of these studies are based in Hamilton, Ontario, but there are 37 clinical trial locations for Brexpiprazole (OPC-34712) in total."

Answered by AI

Has the Food and Drug Administration given its okay to Brexpiprazole (OPC-34712)?

"OPC-34712, or Brexpiprazole, is considered to be safe based on its classification as a Phase 3 trial drug."

Answered by AI

For what purpose is Brexpiprazole most commonly prescribed?

"While typically used to treat acute coryza, Brexpiprazole (OPC-34712) can also be used as an antidepressive agent, or to help with irritability and agitation."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Trial to Evaluate the Short-term Safety & Efficacy of Brexpiprazole Monotherapy in the Treatment of Adolescents With Schizophrenia
2017. "Trial to Evaluate the Short-term Safety & Efficacy of Brexpiprazole Monotherapy in the Treatment of Adolescents With Schizophrenia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03198078.
~41 spots leftby Apr 2025
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