Treatment of Overweight Induced by Antipsychotic Medication in Young People With Autism Spectrum Disorders (ASD)

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.

Conditions

• Overweight
• Autism Spectrum Disorder

Interventions

DRUG

Metformin

Metformin will be dispensed in a liquid suspension of 100 mg/mL. For children 6-9 years of age, metformin will be started at 250 mg at their evening meal for 1 week, followed by the addition of a 250 mg dose at breakfast for 1 week. At the Week 2 visit, if metformin is well-tolerated, the dose will be increased to 500 mg twice daily. For children from 10-17 years of age, metformin will be started at 250 mg at their evening meal for 1 week, followed by the addition of a 250 mg dose at breakfast for 1 week. At the Week 2 visit, if metformin is well-tolerated, the dose will be increased to 500 mg twice daily. At the Week 4 visit, if metformin is well-tolerated, the dose will be increased to 850 mg twice daily.

DRUG

Placebo

The placebo hydrochloride oral solution will be prepared to match the appearance, smell and taste of the metformin as closely as possible. For children from 6-9 years of age, placebo will be started at 250 mg at their evening meal for 1 week, followed by the addition of a 250 mg dose at breakfast for 1 week. At the Week 2 visit, if placebo is well-tolerated, the dose will be increased to 500 mg twice daily. For children from 10-17 years of age, placebo will be started at 250 mg at their evening meal for 1 week, followed by the addition of a 250 mg dose at breakfast for 1 week. At the Week 2 visit, if placebo is well-tolerated, the dose will be increased to 500 mg twice daily. At the Week 4 visit, if placebo is well-tolerated, the dose will be increased to 850 mg twice daily.

Sponsors & Collaborators

• Massachusetts General Hospital

  collaborator OTHER

• Vanderbilt University

  collaborator OTHER

• University of Pittsburgh Medical Center

  collaborator OTHER

• Nationwide Children's Hospital

  collaborator OTHER

• Ohio State University

  collaborator OTHER

• Holland Bloorview Kids Rehabilitation Hospital

  lead OTHER

Principal Investigators

• Evdokia Anagnostou, M.D. · Holland Bloorview Kids Rehabilitation Hospital

• Jeremey Veenstra-VanderWeele, M.D. · Columbia University

• Benjamin Handen, Ph.D. · University of Pittsburgh Medical Center

• Michael Aman, Ph.D. · Ohio State University/Nationwide Children's Hospital

• Eric Butter, Ph.D. · Nationwide Children's Hospital

• Kevin Sanders, M.D. · Vanderbilt University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

6 Years

Max Age

17 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2013-04-30

Primary Completion

2015-06-30

Completion

2015-10-31

Countries

• United States
• Canada

Study Locations