CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 9 enrolled
Drug / intervention
metformin +1 moredrug
Likely dose
metformin 500mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00617240
NCT00617240Phase 2Completed
CompareCT.gov

Metformin Mitigation of Atypical Antipsychotic-Induced Metabolic Dysregulation in Adolescent Youth

University of North Carolina, Chapel Hill·interventional·Posted Feb 15, 2008·Updated Mar 11, 2014

In Brief

A Phase 2 clinical trial evaluating metformin and placebo for Weight Gain. Completed, enrolled 9 participants across 1 site.

Detailed Summary

The purpose of this pilot study is to determine whether starting metformin in conjunction with a second-generation antipsychotic (SGA) and providing information about healthy eating and activity will prevent or reduce the amount of weight gain and the metabolic changes in adolescent youth typically seen with second-generation antipsychotic medication.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsWeight Gain
CountriesUnited States
CollaboratorsFoundation of Hope, North Carolina

Timeline

Phase 2CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedFeb 15, 2008
Enrollment StartJan 1, 2007
Primary CompletionOct 1, 2012
TodayJul 2, 2026
Enrollment to primary: 5.8 yearsPosted 18.4 years ago

Interventions

metformindrug

500mg tablets, 250mg to 2000mg/day, po, BID to TID, 26 weeks

placebodrug

500/0mg tablets, 250-2000mg/day divided BID to TID, po, 26 weeks