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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 Schizoaffective Disorder, sponsored by University of Massachusetts, Worcester.
- Completed
- Registry status
- Phase 4
- Development phase
- 50
- Enrollment target
- 4
- Study locations
NCT03526354: Completed Phase 4 study of Schizophrenia and Schizoaffective Disorder, sponsored by University of Massachusetts, Worcester.
NCT03526354 is a Phase 4 study of Schizophrenia and Schizoaffective Disorder 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. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03526354, a Phase 4 study of Schizophrenia and Schizoaffective Disorder, 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).
Primary Outcome
The Timeline Follow Back (TLFB) scale is used to measure weekly substance use for alcohol, marijuana, cocaine, and/or heroin by assessing the number of days a person used substances in the past week, on a scale from 0 to 7 \[0 = no substances that week; 7 = substance use every day\]. The outcome measure was the number of days per week that participants used a substance. If participants use more than one substance, only the primary substance (one used mostly frequently) was analyzed. While the T
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2018-06-19 |
| Est. Completion | 2024-02-29 |
| Phase | Phase 4 |
What the finished NCT03526354 record still lists
NCT03526354 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 219-participant average among 315 other Schizophrenia trials with a reported enrollment target (77% lower).
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 a single indexed study location in 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, Schizoaffective Disorder, Substance Use Disorders.
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.
Learn More About Clinical Trials
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Where NCT03526354's enrollment target sits among peer trials
50 208th of 315 higher than 101 of 315 other Schizophrenia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Schizophrenia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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