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NCT06174116 · ClinicalTrials.gov registry record · Phase 4
Metabolic Effects of Adjunctive Lumateperone Treatment in Clozapine-Treated Patients With Schizophrenia
A Phase 4 study of Schizophrenia and Schizo Affective Disorder, sponsored by University of Massachusetts, Worcester.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 50
- Enrollment target
- 1
- Study location
NCT06174116 is a Phase 4 study of Schizophrenia and Schizo Affective Disorder that is actively recruiting participants, 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 1 study location across 1 state.
The verdict
NCT06174116, a Phase 4 study of Schizophrenia and Schizo Affective Disorder, is actively recruiting participants, sponsored by University of Massachusetts, Worcester.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 50 participants
- Enrollment target
- 1
- Study location
Study Summary
The main question this study is trying to answer is whether lumateperone, an FDA-approved antipsychotic drug, can help reduce possible side effects of clozapine, such as weight gain and elevated levels of sugar and bad cholesterol. Participants will be randomly assigned to either take lumateperone (Caplyta) or a placebo for 12 weeks, in addition to their regularly prescribed clozapine. During their participation, patients will answer questions about their psychiatric and daily functioning, have blood drawn, and have their body composition analyzed (similar to stepping on a scale).
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Lumateperone
Study Locations (1)
Massachusetts
- UMass Chan Medical School - Worcester
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2024-04-02 |
| Est. Completion | 2026-11 |
| Phase | Phase 4 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06174116
The ClinicalTrials.gov registry entry for NCT06174116 describes a study currently listed as recruiting, 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 2 conditions, with Schizophrenia appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT06174116 reports 1 study location spanning 1 distinct geographic area - top geographies include Massachusetts.
Frequently Asked Questions
What is clinical trial NCT06174116 about?
NCT06174116 is a clinical study titled "Metabolic Effects of Adjunctive Lumateperone Treatment in Clozapine-Treated Patients With Schizophrenia". The main question this study is trying to answer is whether lumateperone, an FDA-approved antipsychotic drug, can help reduce possible side effects of clozapine, such as weight gain and elevated levels of sugar and bad cholesterol. Participants will be randomly assigned to either take lumateperone ...
What is the current status of trial NCT06174116?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 50 participants. The study started on 2024-04-02. Estimated completion is 2026-11.
What conditions does trial NCT06174116 study?
This clinical trial studies the following conditions: Schizophrenia, Schizo Affective Disorder.
What interventions are being tested in trial NCT06174116?
The interventions under investigation include: Placebo (DRUG), Lumateperone (DRUG).
Who is sponsoring clinical trial NCT06174116?
This trial is sponsored by University of Massachusetts, Worcester, which has 240 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06174116 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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