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NCT03526354 · ClinicalTrials.gov registry record · Phase 4

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

A Phase 4 study of Schizophrenia and Substance Use Disorders, sponsored by University of Massachusetts, Worcester.

Completed
Registry status
Phase 4
Development phase
50
Enrollment target
4
Study locations

NCT03526354 is a Phase 4 study of Schizophrenia and Substance Use Disorders that has completed, run by University of Massachusetts, Worcester. The registered enrollment target is 50 participants, below the 219-participant average among 315 other Schizophrenia trials with a reported enrollment target (77% lower). The trial reports 4 study locations across 3 states.

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The verdict

NCT03526354, a Phase 4 study of Schizophrenia and Substance Use Disorders, has completed, sponsored by University of Massachusetts, Worcester.

COMPLETED
Registry status
Phase 4
Development phase
50 participants
Enrollment target
4
Study locations

Study 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).

Interventions

  • OTHER Treatment as Usual
  • DRUG Brexpiprazole

Study Locations (4)

Massachusetts

  • Massachusetts General Hospital - Boston
  • UMass Medical School - Worcester

Georgia

  • Augusta University - Augusta

North Carolina

  • University of North Carolina - Chapel Hill

Trial Details

FieldValue
Enrollment Target 50 participants
Start Date 2018-06-19
Est. Completion 2024-02-29
Phase Phase 4

What the Registry Record Tells You About NCT03526354

The ClinicalTrials.gov registry entry for NCT03526354 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 50 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 219-participant average among 315 other Schizophrenia trials with a reported enrollment target (77% lower). The listed sponsor is University of Massachusetts, Worcester, which has 240 total studies on file at ClinicalTrials.gov.

The record links to 3 conditions, with Schizophrenia appearing as the primary indexed condition, and to 2 interventions - of which Treatment as Usual is the first listed.

NCT03526354 reports 4 study locations spanning 3 distinct geographic areas - top geographies include Massachusetts, Georgia, North Carolina.

Frequently Asked Questions

What is clinical trial NCT03526354 about?

NCT03526354 is a clinical study titled "Controlled Trial of Brexpiprazole For The Treatment of Co-occurring Schizophrenia and Substance Use Disorder". 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 brexp...

What is the current status of trial NCT03526354?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 50 participants. The study started on 2018-06-19. Estimated completion is 2024-02-29.

What conditions does trial NCT03526354 study?

This clinical trial studies the following conditions: Schizophrenia, Substance Use Disorders, Schizoaffective Disorder.

What interventions are being tested in trial NCT03526354?

The interventions under investigation include: Treatment as Usual (OTHER), Brexpiprazole (DRUG).

Who is sponsoring clinical trial NCT03526354?

This trial is sponsored by University of Massachusetts, Worcester, which has 240 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03526354 being conducted?

This trial has 4 study locations across Georgia, Massachusetts, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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