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Clinical Trial Summary

The purpose of this study is to determine whether metformin is safe and effective in the treatment of weight or weight gain in young people with Autism Spectrum Disorders (ASD) who are currently taking atypical antipsychotic medication.


Clinical Trial Description

This is a double-blind, placebo-controlled, multi-site randomized trial to evaluate oral fixed dose metformin (Riomet®) in decreasing weight or weight gain in children ages 6-17 years, 4 months with ASD who are currently taking atypical antipsychotic medication. A 16-week, double-blind, placebo-controlled randomized trial of metformin with dose guided by age will be conducted. A secondary study aim will be to assess the long-term safety and efficacy of metformin by conducting a 16-week open label continuation. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT01825798
Study type Interventional
Source Anagnostou, Evdokia, M.D.
Contact
Status Completed
Phase Phase 3
Start date April 2013
Completion date October 2015

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