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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: Completed Phase 1 study, sponsored by State University of New York at Buffalo.
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, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (83% lower). According to ClinicalTrials.gov, the official US trial registry.
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
Primary Outcome
Change in weight will be assessed at baseline, weekly during study period, end point, and follow up.
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 |
What the finished NCT05207982 record still lists
NCT05207982 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (83% lower).
The record links to 0 conditions, and to 1 intervention - of which Family Based weight management program is the first listed.
NCT05207982 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05207982's enrollment target sits among peer trials
10 1913th of 2000 higher than 46 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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