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NCT00816907 · ClinicalTrials.gov registry record · Phase 4

The Use of Metformin in the Treatment of Antipsychotic-Induced Weight Gain in Schizophrenia (The METS Study)

A Phase 4 study, sponsored by National Institute of Mental Health (NIMH).

Completed
Registry status
Phase 4
Development phase
146
Enrollment target

NCT00816907: Completed Phase 4 study, sponsored by National Institute of Mental Health (NIMH).

NCT00816907 is a Phase 4 study that has completed, run by National Institute of Mental Health (NIMH). The registered enrollment target is 146 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (72% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00816907, a Phase 4 study, has completed, sponsored by National Institute of Mental Health (NIMH).

COMPLETED
Registry status
Phase 4
Development phase
146 participants
Enrollment target

Study Summary

This study will test the usefulness of the medication metformin in treating people with schizophrenia or schizoaffective disorder who are overweight and also taking antipsychotic medications.

Primary Outcome

Mean difference in body weight change between participants assigned to metformin and participants assigned to placebo from baseline to last study visit (up to 16 weeks)

Interventions

  • DRUG Placebo
  • DRUG Metformin

Trial Details

FieldValue
Enrollment Target 146 participants
Start Date 2009-01
Est. Completion 2010-03
Phase Phase 4

What the finished NCT00816907 record still lists

NCT00816907 is an interventional study that assigns participants to a tested intervention. The registered 146 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (72% lower).

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT00816907 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00816907 about?

NCT00816907 is a clinical study titled "The Use of Metformin in the Treatment of Antipsychotic-Induced Weight Gain in Schizophrenia (The METS Study)". This study will test the usefulness of the medication metformin in treating people with schizophrenia or schizoaffective disorder who are overweight and also taking antipsychotic medications.

What is the current status of trial NCT00816907?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 146 participants. The study started on 2009-01. Estimated completion is 2010-03.

What interventions are being tested in trial NCT00816907?

The interventions under investigation include: Placebo (DRUG), Metformin (DRUG).

Who is sponsoring clinical trial NCT00816907?

This trial is sponsored by National Institute of Mental Health (NIMH), which has 343 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00816907's enrollment target sits among peer trials

146 571st of 2000 higher than 1,428 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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Source: ClinicalTrials.gov NCT00816907, the US trial registry maintained by the National Library of Medicine. NCT00816907 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.