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

Primary Purpose

Overweight, Autism Spectrum Disorder

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Metformin

Placebo

About this trial

This is an interventional treatment trial for Overweight focused on measuring Metformin, Overweight, Atypical Antipsychotic, Medication, Randomized Clinical Trial, Children

Eligibility Criteria

6 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Ohio State University/Nationwide Children's Hospital
University of Pittsburgh Medical Center
Vanderbilt University
Holland Bloorview Kids Rehabilitation Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo Hydrochloride Oral Solution

Metformin

Arm Description

Outcomes

Primary Outcome Measures

Change in Body Mass Index Z-score

Secondary Outcome Measures

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

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

Changes in Additional Body Composition Parameters (Absolute BMI)

Changes in Additional Body Composition Parameters (Abdominal Circumference)

Changes in Additional Body Composition Parameters (Hip Circumference)

Changes in Fasting Metabolic Parameters (Total Cholesterol)

Changes in Fasting Metabolic Parameters (LDL)

Changes in Fasting Metabolic Parameters (HDL)

Changes in Fasting Metabolic Parameters (Triglycerides)

Changes in Fasting Metabolic Parameters (Glucose)

Changes in Fasting Metabolic Parameters (Insulin)

Full Information

NCT ID

NCT01825798

First Posted

February 7, 2013

Last Updated

January 25, 2018

Sponsor

Evdokia Anagnostou

Collaborators

Massachusetts General Hospital, Vanderbilt University, University of Pittsburgh, Nationwide Children's Hospital, Ohio State University

1. Study Identification

Unique Protocol Identification Number

NCT01825798

Brief Title

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

Acronym

MET

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2018

Overall Recruitment Status

Completed

Study Start Date

April 2013 (undefined)

Primary Completion Date

June 2015 (Actual)

Study Completion Date

October 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Evdokia Anagnostou

Collaborators

Massachusetts General Hospital, Vanderbilt University, University of Pittsburgh, Nationwide Children's Hospital, Ohio State University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Overweight, Autism Spectrum Disorder

Keywords

Metformin, Overweight, Atypical Antipsychotic, Medication, Randomized Clinical Trial, Children

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

60 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Placebo Hydrochloride Oral Solution

Arm Type

Placebo Comparator

Arm Title

Metformin

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Metformin

Other Intervention Name(s)

Riomet

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

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 Outcome Measure Information:

Title

Change in Body Mass Index Z-score

Time Frame

Baseline, 16 Weeks

Secondary Outcome Measure Information:

Title

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

Time Frame

Baseline, 16 Weeks

Title

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

Time Frame

Baseline, 16 Weeks

Title

Changes in Additional Body Composition Parameters (Absolute BMI)

Time Frame

Baseline, 16 Weeks

Title

Changes in Additional Body Composition Parameters (Abdominal Circumference)

Time Frame

Baseline, 16 Weeks

Title

Changes in Additional Body Composition Parameters (Hip Circumference)

Time Frame

Baseline, 16 Weeks

Title

Changes in Fasting Metabolic Parameters (Total Cholesterol)

Time Frame

Baseline, 16 Weeks

Title

Changes in Fasting Metabolic Parameters (LDL)

Time Frame

Baseline, 16 Weeks

Title

Changes in Fasting Metabolic Parameters (HDL)

Time Frame

Baseline, 16 Weeks

Title

Changes in Fasting Metabolic Parameters (Triglycerides)

Time Frame

Baseline, 16 Weeks

Title

Changes in Fasting Metabolic Parameters (Glucose)

Time Frame

Baseline, 16 Weeks

Title

Changes in Fasting Metabolic Parameters (Insulin)

Time Frame

Baseline, 16 Weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

6 Years

Maximum Age & Unit of Time

17 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials: