NCT03198078

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

A Multicenter, Randomized, Double-blind, Placebo- and Active-controlled Trial to Evaluate the Efficacy of Brexpiprazole Monotherapy for the Treatment in Adolescents (13-17 Years Old) With Schizophrenia

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 316 (actual)
• Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc. · Industry
• Sex: All
• Age: 13 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

This is a multicenter, randomized, double-blind, placebo- and active-controlled trial to evaluate the safety and efficacy of brexpiprazole monotherapy compared to placebo in adolescent subjects (ages 13-17) with a DSM-5 diagnosis of schizophrenia.

Conditions

• Schizophrenia

Interventions

Type	Name	Description
DRUG	Brexpiprazole (OPC-34712)	Once-daily, tablets
DRUG	Aripiprazole	Once-daily, tablets
DRUG	Placebo	Once-daily, tablets

Timeline

• Start date: 2017-06-30
• Primary completion: 2023-04-03
• Completion: 2023-04-03
• First posted: 2017-06-23
• Last updated: 2023-12-20
• Results posted: 2023-12-20

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study