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NCT00391261 · ClinicalTrials.gov registry record · Phase 4
An Open-label Trial of Metformin for Weight Control of Pediatric Patients on Antipsychotic Medications.
A Phase 4 study, sponsored by Cambridge Health Alliance.
- Completed
- Registry status
- Phase 4
- Development phase
- 11
- Enrollment target
NCT00391261: Completed Phase 4 study, sponsored by Cambridge Health Alliance.
NCT00391261 is a Phase 4 study that has completed, run by Cambridge Health Alliance. The registered enrollment target is 11 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00391261, a Phase 4 study, has completed, sponsored by Cambridge Health Alliance.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 11 participants
- Enrollment target
Study Summary
The aim of this study is to evaluate the effectiveness, safety, and tolerability of metformin treatment in children and adolescents suffering from weight gain secondary to use of atypical antipsychotic medications. In this 12 week, open-label study we will investigate metformin's effects on weight control and/or weight loss. We hypothesize that metformin would prevent further weight gain or lead to weight loss, resulting in amelioration of one of the most significant side effects of atypical antipsychotic use.
Interventions
- DRUG Metformin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11 participants |
| Start Date | 2006-07 |
| Est. Completion | 2007-10 |
| Phase | Phase 4 |
What the finished NCT00391261 record still lists
NCT00391261 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 11 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 1 intervention - of which Metformin is the first listed.
NCT00391261 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00391261 about?
NCT00391261 is a clinical study titled "An Open-label Trial of Metformin for Weight Control of Pediatric Patients on Antipsychotic Medications.". The aim of this study is to evaluate the effectiveness, safety, and tolerability of metformin treatment in children and adolescents suffering from weight gain secondary to use of atypical antipsychotic medications. In this 12 week, open-label study we will investigate metformin's effects on weight c...
What is the current status of trial NCT00391261?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 11 participants. The study started on 2006-07. Estimated completion is 2007-10.
What interventions are being tested in trial NCT00391261?
The interventions under investigation include: Metformin (DRUG).
Who is sponsoring clinical trial NCT00391261?
This trial is sponsored by Cambridge Health Alliance, which has 45 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00391261's enrollment target sits among peer trials
11 1931st of 2000 higher than 61 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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