MedTrace Logo

Controlled Trial of Brexpiprazole For The Treatment of Co-occurring Schizophrenia and Substance Use Disorder

NCT03526354 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2025-05-23

Study results available
· View outcomes & findings →

Summary

The proposed study is a 4-site, 12-week, novel, feasibility, investigation of patients who have co-occurring diagnoses of schizophrenia and current substance use disorder (alcohol, cocaine, heroin, or cannabis). Thirty-nine participants will be randomly assigned to switch to brexpiprazole (the brexpiprazole group) or remain on the same antipsychotic treatment (the control group). The study will be conducted at 4 sites in the US. The investigators expect to enroll 80 subjects across 3 sites. UMass Medical School, Worcester MA is the lead site. Sub-sites include Massachusetts General Hospital (MGH) and the University of North Carolina at Chapel Hill (UNC).

Conditions

Interventions

DRUG

Brexpiprazole

Brexpiprazole 4mg daily for 12 weeks

OTHER

Treatment as Usual

Current antipsychotic medication for 12 weeks

Sponsors & Collaborators

  • Massachusetts General Hospital

    collaborator OTHER

  • University of North Carolina, Chapel Hill

    collaborator OTHER

  • Otsuka Pharmaceutical Co., Ltd.

    collaborator INDUSTRY

  • Augusta University

    collaborator OTHER

  • University of Massachusetts, Worcester

    lead OTHER

Principal Investigators

  • Xiaoduo Fan, MD · University of Massachusetts, Worcester

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-06-19
Primary Completion
2024-02-29
Completion
2024-02-29
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

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 NCT03526354 on ClinicalTrials.gov