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

Overweight Clinical Trial

— MET  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01825798
• Other study ID #: MET-10-2012
• Status: Completed
• Phase: Phase 3
• First received: February 7, 2013
• Last updated: January 25, 2018
• Start date: April 2013
• Est. completion date: October 2015

Study information

• Verified date: January 2018
• Source: Anagnostou, Evdokia, M.D.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: October 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 17 Years

Eligibility

Inclusion Criteria:

1. 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.

2. Minimum of 1 month on a stable atypical antipsychotic dose with no plans to change the dose for the next 4 months.

3. 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).

4. Age 6 years to 17 years, 4 months.

5. 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.

6. 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:

1. History of intolerable adverse effects with metformin.

2. Prior history of an exposure to metformin of sufficient dose or duration to determine response status.

3. 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.

4. Use of cationic drugs excreted by the kidneys.

5. Planned surgery or procedure requiring contrast.

6. Pregnant at screening contact.

7. On other psychotropic concomitant medications for less than 2 months.

8. 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.

9. Unable to tolerate blood work.

10. Current use of medication for target symptoms of appetite or weight loss.

11. Planned change of medication, medication dose, or behavioral treatment targeting weight loss during the study period.

Related Conditions & MeSH terms

• Autism Spectrum Disorder
• Autistic Disorder
• Child Development Disorders, Pervasive
• Disease
• Overweight

Intervention

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.
• 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.

Locations

Country	Name	City	State
Canada	Holland Bloorview Kids Rehabilitation Hospital	Toronto	Ontario
United States	Ohio State University/Nationwide Children's Hospital	Columbus	Ohio
United States	Vanderbilt University	Nashville	Tennessee
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania

Sponsors (6)

Lead Sponsor	Collaborator
Evdokia Anagnostou	Massachusetts General Hospital, Nationwide Children's Hospital, Ohio State University, University of Pittsburgh, Vanderbilt University

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Body Mass Index Z-score		Baseline, 16 Weeks
Secondary	Changes in Additional Body Composition Parameters (Absolute Change in Weight)		Baseline, 16 Weeks
Secondary	Changes in Additional Body Composition Parameters (Relative Change in Weight)		Baseline, 16 Weeks
Secondary	Changes in Additional Body Composition Parameters (Absolute BMI)		Baseline, 16 Weeks
Secondary	Changes in Additional Body Composition Parameters (Abdominal Circumference)		Baseline, 16 Weeks
Secondary	Changes in Additional Body Composition Parameters (Hip Circumference)		Baseline, 16 Weeks
Secondary	Changes in Fasting Metabolic Parameters (Total Cholesterol)		Baseline, 16 Weeks
Secondary	Changes in Fasting Metabolic Parameters (LDL)		Baseline, 16 Weeks
Secondary	Changes in Fasting Metabolic Parameters (HDL)		Baseline, 16 Weeks
Secondary	Changes in Fasting Metabolic Parameters (Triglycerides)		Baseline, 16 Weeks
Secondary	Changes in Fasting Metabolic Parameters (Glucose)		Baseline, 16 Weeks
Secondary	Changes in Fasting Metabolic Parameters (Insulin)		Baseline, 16 Weeks