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NCT00617058 · ClinicalTrials.gov registry record · Phase 2

Improving Metabolic Parameters of Antipsychotic Child Treatment With Ziprasidone, Aripiprazole, and Clozapine

A Phase 2 study, sponsored by University of North Carolina, Chapel Hill.

Terminated
Registry status
Phase 2
Development phase
1
Enrollment target

NCT00617058: Clinical Trial Phase 2 study, sponsored by University of North Carolina, Chapel Hill.

NCT00617058 is a Phase 2 study that was terminated before completion, run by University of North Carolina, Chapel Hill. The registered enrollment target is 1 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00617058, a Phase 2 study, was terminated before completion, sponsored by University of North Carolina, Chapel Hill.

TERMINATED
Registry status
Phase 2
Development phase
1 participants
Enrollment target

Study Summary

The purpose of this study is to evaluate the relative risks and benefits of two approaches to the control of weight gain and other negative side effects in children and adolescents on 2nd generation antipsychotics (SGA): * Healthy lifestyle instruction (nutritional and physical activity surveillance and advice) + continuation of current SGA; * Add the diabetes drug, metformin + continuation of current SGA.

Interventions

  • DRUG metformin
  • BEHAVIORAL healthy lifestyle intervention

Trial Details

FieldValue
Enrollment Target 1 participants
Start Date 2007-03
Est. Completion 2010-09
Phase Phase 2

Why NCT00617058 stopped before completion

NCT00617058 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 1 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (99% lower).

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

NCT00617058 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00617058 about?

NCT00617058 is a clinical study titled "Improving Metabolic Parameters of Antipsychotic Child Treatment With Ziprasidone, Aripiprazole, and Clozapine". The purpose of this study is to evaluate the relative risks and benefits of two approaches to the control of weight gain and other negative side effects in children and adolescents on 2nd generation antipsychotics (SGA): * Healthy lifestyle instruction (nutritional and physical activity surveillanc...

What is the current status of trial NCT00617058?

This trial is currently terminated. It is a Phase 2 study. The enrollment target is 1 participants. The study started on 2007-03. Estimated completion is 2010-09.

What interventions are being tested in trial NCT00617058?

The interventions under investigation include: metformin (DRUG), healthy lifestyle intervention (BEHAVIORAL).

Who is sponsoring clinical trial NCT00617058?

This trial is sponsored by University of North Carolina, Chapel Hill, which has 1,109 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00617058's enrollment target sits among peer trials

1 2001st of 2000 the lowest of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 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 NCT00617058, the US trial registry maintained by the National Library of Medicine. NCT00617058 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.