Treatment of Overweight Induced by Antipsychotic Medication in Young People With Autism Spectrum Disorders (ASD)
Overview[ - collapse ][ - ]
Purpose | 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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Condition | Overweight Autism Spectrum Disorder |
Intervention | Drug: Metformin |
Phase | Phase 3 |
Sponsor | Evdokia Anagnostou |
Responsible Party | Anagnostou, Evdokia, M.D. |
ClinicalTrials.gov Identifier | NCT01825798 |
First Received | February 7, 2013 |
Last Updated | April 21, 2014 |
Last verified | April 2014 |
Tracking Information[ + expand ][ + ]
First Received Date | February 7, 2013 |
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Last Updated Date | April 21, 2014 |
Start Date | April 2013 |
Estimated Primary Completion Date | March 2016 |
Current Primary Outcome Measures | change in body mass index z-score [Time Frame: baseline, 16 weeks] [Designated as safety issue: Yes] |
Current Secondary Outcome Measures |
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Descriptive Information[ + expand ][ + ]
Brief Title | Treatment of Overweight Induced by Antipsychotic Medication in Young People With Autism Spectrum Disorders (ASD) |
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Official Title | Treatment of Overweight Induced by Antipsychotic Medication in Young People With Autism Spectrum Disorders (ASD) |
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. |
Study Type | Interventional |
Study Phase | Phase 3 |
Study Design | Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment |
Condition |
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Intervention | Drug: Metformin Other Names: Riomet |
Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
Recruitment Status | Recruiting |
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Estimated Enrollment | 90 |
Estimated Completion Date | March 2016 |
Estimated Primary Completion Date | December 2015 |
Eligibility Criteria | Inclusion Criteria: 1. Diagnosis of Autism Spectrum Disorder (autistic disorder, pervasive developmental disorder NOS, Asperger's disorder) based upon an ADOS and 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, 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. |
Gender | Both |
Ages | 6 Years |
Accepts Healthy Volunteers | No |
Contacts | Contact: Evdokia Anagnostou, MD 416-425-6220 eanagnostou@hollandbloorview.ca |
Location Countries | United States, Canada |
Administrative Information[ + expand ][ + ]
NCT Number | NCT01825798 |
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Other Study ID Numbers | MET-10-2012 |
Has Data Monitoring Committee | Yes |
Information Provided By | Anagnostou, Evdokia, M.D. |
Study Sponsor | Evdokia Anagnostou |
Collaborators | Massachusetts General Hospital Vanderbilt University University of Pittsburgh Nationwide Children's Hospital Ohio State University |
Investigators | Principal Investigator: Evdokia Anagnostou, MD, FRCPC Holland Bloorview Kids Rehabilitation HospitalPrincipal Investigator: Jeremey Veenstra-VanderWeele, MD Vanderbilt UniversityPrincipal Investigator: Benjamin Handen, PhD University of PittsburghPrincipal Investigator: Michael Aman, PhD Ohio State University/Nationwide Children's Hospital |
Verification Date | April 2014 |
Locations[ + expand ][ + ]
Ohio State University/Nationwide Children's Hospital | Columbus, Ohio, United States, 43210 Contact: Wagner Alexis, BA | 614-685-3219 | alexis.wagner@osumc.eduPrincipal Investigator: Michael Aman, PhD Recruiting |
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University of Pittsburgh Medical Center | Pittsburgh, Pennsylvania, United States, 15203 Contact: Sarah McAuliffe-Bellin, M.Ed | 412-235-5447 | mcausj@upmc.eduPrincipal Investigator: Benjamin Handen, PhD Recruiting |
Vanderbilt University | Nashville, Tennessee, United States, 37212 Contact: Sarah Marler, MA | 615-936-3288 | sarah.marler@vanderbilt.eduPrincipal Investigator: Jeremy Veenstra-VanderWeele, MD Recruiting |
Holland Bloorview Kids Rehabilitation Hospital | Toronto, Ontario, Canada, M4G 1R8 Contact: Rianne Hastie, MSW, RSW | 416-425-62203456 | rhastie@hollandbloorview.caPrincipal Investigator: Evdokia Anagnostou, MD Recruiting |