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Completed

NCT Number: NCT01825798

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

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.

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Key information

Conditions

Overweight Autism Spectrum Disorder Body Weight Child Development Disorders, Pervasive Mental Disorders Neurodevelopmental Disorders Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

6 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Holland Bloorview Kids Rehabilitation Hospital, Toronto, Ontario, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosis of Autism Spectrum Disorder (autistic disorder, pervasive developmental disorder not otherwise specified), Asperger's disorder) based upon an Autism Diagnostic Observation Scale (ADOS) and Diagnostic and Statistical Manual (DSM-IV) interview.
  • Minimum of 1 month on a stable atypical antipsychotic dose with no plans to change the dose for the next 4 months.
  • A documented greater than/equal to 7% increase in BMI since starting atypical antipsychotic therapy(going back as far as prior 12 months); or, if BMI is greater or equal to 85th percentile corrected for age and sex, then a greater than 5% body weight increase per year (prorated at greater than 5% body weight increase if medicated for longer than a year).
  • Age 6 years to 17 years, 4 months.
  • Subjects and their parents (guardians) must be judged reliable for medication compliance and must agree to keep appointments for study visits and tests as outlined in the protocol.
  • Prior to the conduct of any study-specific procedures, the subject must provide assent to participate in the study (if developmentally appropriate), and their parents (guardians) must provide written informed consent.

Exclusion criteria

  • History of intolerable adverse effects with metformin.
  • Prior history of an exposure to metformin of sufficient dose or duration to determine response status.
  • History of liver disease, renal impairment, congestive heart failure, pernicious anemia, any other condition increasing the risk for lactic acidosis, or any serious medical illness requiring treatment.
  • Use of cationic drugs excreted by the kidneys.
  • Planned surgery or procedure requiring contrast.
  • Pregnant at screening contact.
  • On other psychotropic concomitant medications for less than 2 months.
  • Treatment or planned treatment with concomitant medications with unacceptable interactions with metformin, including topiramate, levetiracetam, beta blockers, angiotensin-converting-enzyme (ACE) inhibitors, diuretics, or histamine H2 receptor antagonists.
  • Unable to tolerate blood work.
  • Current use of medication for target symptoms of appetite or weight loss.
  • Planned change of medication, medication dose, or behavioral treatment targeting weight loss during the study period.

Treatment and study plan

metformin

Drug

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.

Other names: Riomet

Placebo

Drug

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.

Primary outcomes

  1. Change in Body Mass Index Z-score

    Time frame: Baseline, 16 Weeks

Secondary outcomes

  1. Changes in Additional Body Composition Parameters (Absolute Change in Weight)

    Time frame: Baseline, 16 Weeks

  2. Changes in Additional Body Composition Parameters (Relative Change in Weight)

    Time frame: Baseline, 16 Weeks

  3. Changes in Additional Body Composition Parameters (Absolute BMI)

    Time frame: Baseline, 16 Weeks

  4. Changes in Additional Body Composition Parameters (Abdominal Circumference)

    Time frame: Baseline, 16 Weeks

  5. Changes in Additional Body Composition Parameters (Hip Circumference)

    Time frame: Baseline, 16 Weeks

  6. Changes in Fasting Metabolic Parameters (Total Cholesterol)

    Time frame: Baseline, 16 Weeks

  7. Changes in Fasting Metabolic Parameters (LDL)

    Time frame: Baseline, 16 Weeks

  8. Changes in Fasting Metabolic Parameters (HDL)

    Time frame: Baseline, 16 Weeks

  9. Changes in Fasting Metabolic Parameters (Triglycerides)

    Time frame: Baseline, 16 Weeks

  10. Changes in Fasting Metabolic Parameters (Glucose)

    Time frame: Baseline, 16 Weeks

  11. Changes in Fasting Metabolic Parameters (Insulin)

    Time frame: Baseline, 16 Weeks

Sponsors and collaborators

Lead sponsor

Holland Bloorview Kids Rehabilitation Hospital

Other

Collaborators

  • Massachusetts General Hospital
  • Nationwide Children's Hospital
  • Ohio State University
  • University of Pittsburgh Medical Center
  • Vanderbilt University

Registry information

Acronym: MET

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Apr 8, 2013
Registry last updated
Jul 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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