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NCT02796144 · ClinicalTrials.gov registry record · Phase 4
MEtformin and Lorcaserin for WeighT Loss in Schizophrenia
A Phase 4 study, sponsored by University of North Carolina, Chapel Hill.
- Terminated
- Registry status
- Phase 4
- Development phase
- 71
- Enrollment target
NCT02796144 is a Phase 4 study that was terminated before completion, run by University of North Carolina, Chapel Hill. The registered enrollment target is 71 participants.
The verdict
NCT02796144, a Phase 4 study, was terminated before completion, sponsored by University of North Carolina, Chapel Hill.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 71 participants
- Enrollment target
Study Summary
Purpose: The purpose of this study is to test new pharmacologic strategies for weight loss in patients with schizophrenia, a population for which no current weight-loss treatments have gained widespread use. The goal is to recruit overweight people with schizophrenia to participate in a 52-week double-blind, randomized study to assess the efficacy and safety of lorcaserin/metformin combination treatment, lorcaserin monotherapy, and placebo on weight, body composition, and measures of glucose and lipid metabolism. Participants: Approximately 110 subjects will be enrolled at four clinical sites (UNC Chapel Hill, Carolina Behavioral Care, Columbia University, and Augusta University) Procedures (methods): Behavioral: All participants will be offered a behavioral intervention of weekly diet and exercise counseling aimed at modifying cardiovascular risk factors. This intervention will be provided at all in-person study visits after the Baseline Visit and supplemented with weekly interim phone calls to reinforce lessons between visits. Pharmacological Intervention: All participants who meet entry criteria will be randomized to one of the three treatment groups (lorcaserin/metformin, lorcaserin, and placebo).
Interventions
- DRUG Placebo
- DRUG Metformin
- DRUG Lorcaserin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 71 participants |
| Start Date | 2016-09 |
| Est. Completion | 2020-02-14 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02796144
The ClinicalTrials.gov registry entry for NCT02796144 describes a study currently listed as terminated, categorized as Phase 4. The registered enrollment target is 71 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of North Carolina, Chapel Hill, which has 1,109 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT02796144 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02796144 about?
NCT02796144 is a clinical study titled "MEtformin and Lorcaserin for WeighT Loss in Schizophrenia". Purpose: The purpose of this study is to test new pharmacologic strategies for weight loss in patients with schizophrenia, a population for which no current weight-loss treatments have gained widespread use. The goal is to recruit overweight people with schizophrenia to participate in a 52-week doub...
What is the current status of trial NCT02796144?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 71 participants. The study started on 2016-09. Estimated completion is 2020-02-14.
What interventions are being tested in trial NCT02796144?
The interventions under investigation include: Placebo (DRUG), Metformin (DRUG), Lorcaserin (DRUG).
Who is sponsoring clinical trial NCT02796144?
This trial is sponsored by University of North Carolina, Chapel Hill, which has 1,109 total clinical trials registered on ClinicalTrials.gov.
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