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Trial to Evaluate the Short-term Safety & Efficacy of Brexpiprazole Monotherapy in the Treatment of Adolescents With Schizophrenia

NCT03198078 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 316

Last updated 2023-12-20

Study results available
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Summary

To determine the safety \& efficacy of brexpiprazole monotherapy in the treatment of adolescents with schizophrenia.

Conditions

Interventions

DRUG

Brexpiprazole (OPC-34712)

Once-daily, tablets

DRUG

Aripiprazole

Once-daily, tablets

DRUG

Placebo

Once-daily, tablets

Sponsors & Collaborators

  • H. Lundbeck A/S

    collaborator INDUSTRY

  • Otsuka Pharmaceutical Development & Commercialization, Inc.

    lead INDUSTRY

Principal Investigators

  • Caroline Ward, PhD. · Otsuka Pharmaceutical Development & Commercialization, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
13 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-06-30
Primary Completion
2023-04-03
Completion
2023-04-03
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03198078 on ClinicalTrials.gov