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

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ClinicalTrials.gov Identifier: NCT01825798
Recruitment Status : Completed
First Posted : April 8, 2013
Results First Posted : February 22, 2018
Last Update Posted : February 22, 2018
Sponsor:
Collaborators:
Massachusetts General Hospital
Vanderbilt University
University of Pittsburgh
Nationwide Children's Hospital
Ohio State University
Information provided by (Responsible Party):
Evdokia Anagnostou, Anagnostou, Evdokia, M.D.

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.

Condition or disease Intervention/treatment Phase
Overweight Autism Spectrum Disorder Drug: Metformin Drug: Placebo Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Treatment of Overweight Induced by Antipsychotic Medication in Young People With Autism Spectrum Disorders (ASD)
Study Start Date : April 2013
Actual Primary Completion Date : June 2015
Actual Study Completion Date : October 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Placebo Hydrochloride Oral Solution 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.

Experimental: Metformin 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.
Other Name: Riomet




Primary Outcome Measures :
  1. Change in Body Mass Index Z-score [ Time Frame: Baseline, 16 Weeks ]

Secondary Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01825798


Locations
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United States, Ohio
Ohio State University/Nationwide Children's Hospital
Columbus, Ohio, United States, 43210
United States, Pennsylvania
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15203
United States, Tennessee
Vanderbilt University
Nashville, Tennessee, United States, 37212
Canada, Ontario
Holland Bloorview Kids Rehabilitation Hospital
Toronto, Ontario, Canada, M4G 1R8
Sponsors and Collaborators
Evdokia Anagnostou
Massachusetts General Hospital
Vanderbilt University
University of Pittsburgh
Nationwide Children's Hospital
Ohio State University
Investigators
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Principal Investigator: Evdokia Anagnostou, M.D. Holland Bloorview Kids Rehabilitation Hospital
Principal Investigator: Jeremey Veenstra-VanderWeele, M.D. Columbia University
Principal Investigator: Benjamin Handen, Ph.D. University of Pittsburgh Medical Center
Principal Investigator: Michael Aman, Ph.D. Ohio State University/Nationwide Children's Hospital
Principal Investigator: Eric Butter, Ph.D. Nationwide Children's Hospital
Principal Investigator: Kevin Sanders, M.D. Vanderbilt University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Evdokia Anagnostou, Principal Investigator, Anagnostou, Evdokia, M.D.
ClinicalTrials.gov Identifier: NCT01825798     History of Changes
Other Study ID Numbers: MET-10-2012
First Posted: April 8, 2013    Key Record Dates
Results First Posted: February 22, 2018
Last Update Posted: February 22, 2018
Last Verified: January 2018
Keywords provided by Evdokia Anagnostou, Anagnostou, Evdokia, M.D.:
Metformin
Overweight
Atypical Antipsychotic
Medication
Randomized Clinical Trial
Children
Additional relevant MeSH terms:
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Autistic Disorder
Autism Spectrum Disorder
Metformin
Overweight
Child Development Disorders, Pervasive
Body Weight
Signs and Symptoms
Neurodevelopmental Disorders
Mental Disorders
Antipsychotic Agents
Hypoglycemic Agents
Physiological Effects of Drugs
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs