Treatment of Overweight Induced by Antipsychotic Medication in Young People With Autism Spectrum Disorders (ASD)
Condition: Overweight; Autism Spectrum Disorder
MeSH terms: Overweight; Autistic Disorder; Autism Spectrum Disorder; Child Development Disorders, Pervasive
Intervention: Metformin; Placebo
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.; 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.
Intervention MeSH terms: Metformin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 60.0
Sex: All
Minimum age: 6 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: Metformin; Overweight; Atypical Antipsychotic; Medication; Randomized Clinical Trial; Children

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.
    

Eligibility criteria:

        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.