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NCT05207982 · ClinicalTrials.gov registry record · Phase 1
Weight Management Program for Patients With First Episode Psychosis
A Phase 1 study, sponsored by State University of New York at Buffalo.
- Completed
- Registry status
- Phase 1
- Development phase
- 10
- Enrollment target
NCT05207982 is a Phase 1 study that has completed, run by State University of New York at Buffalo. The registered enrollment target is 10 participants.
The verdict
NCT05207982, a Phase 1 study, has completed, sponsored by State University of New York at Buffalo.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 10 participants
- Enrollment target
Study Summary
Severe mental illnesses (SMI), such as schizophrenia, are associated with increased morbidity and mortality in large part due to obesity and concomitant metabolic disorders. People with SMI have twice the risk of becoming obese, driven by the use of antipsychotic medications. These antipsychotic medications are dopamine antagonists, which reduce brain dopamine levels, leading to an increase in food reinforcement, which leads to weight gain. This weight gain occurs very rapidly with the initiation of these medications, as do increases in LDL cholesterol, insulin, and leptin. While there have been attempts to develop weight loss programs, a recent meta-analysis concluded that these interventions led to statistically significant weight loss that was of no clinical significance and did not last beyond the intervention. Given the rapid weight gain/metabolic changes and the findings that it is easier to prevent weight gain than to lose weight, interventions targeting the early phases of a first episode of psychosis (FEP) are critical. However, the very few attempts have failed to address two key aspects of first episode psychosis. First, antipsychotic medications increase the reinforcing value of food and interventions have not included strategies to provide alternative reinforcements. Second, most patients experiencing FEP live with and are dependent on their parents, but existing interventions have not utilized parents in support of exercise and dietary changes. The purpose of this project is to assess the feasibility and acceptability of, and to provide preliminary evidence for the efficacy of a Family-Based Treatment (FBT) that includes both the patient and the parent in the intervention and provides structured help in developing alternative reinforcements that support exercise and dietary changes. The specific aims of this project are: 1. Recruit and provide FBT to 12 FEP patients and their parents using a multiple baseline single case experimental design; 2. Eval
Interventions
- BEHAVIORAL Family Based weight management program
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2022-07-15 |
| Est. Completion | 2023-07-05 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05207982
The ClinicalTrials.gov registry entry for NCT05207982 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 10 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is State University of New York at Buffalo, which has 243 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Family Based weight management program is the first listed.
NCT05207982 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05207982 about?
NCT05207982 is a clinical study titled "Weight Management Program for Patients With First Episode Psychosis". Severe mental illnesses (SMI), such as schizophrenia, are associated with increased morbidity and mortality in large part due to obesity and concomitant metabolic disorders. People with SMI have twice the risk of becoming obese, driven by the use of antipsychotic medications. These antipsychotic med...
What is the current status of trial NCT05207982?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 10 participants. The study started on 2022-07-15. Estimated completion is 2023-07-05.
What interventions are being tested in trial NCT05207982?
The interventions under investigation include: Family Based weight management program (BEHAVIORAL).
Who is sponsoring clinical trial NCT05207982?
This trial is sponsored by State University of New York at Buffalo, which has 243 total clinical trials registered on ClinicalTrials.gov.
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