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

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.
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
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	changes in additional body composition parameters (absolute change in weight) [Time Frame: baseline, 16 weeks] [Designated as safety issue: Yes] changes in additional body composition parameters (relative change in weight) [Time Frame: baseline, 16 weeks] [Designated as safety issue: Yes] changes in additional body composition parameters (absolute BMI) [Time Frame: baseline, 16 weeks] [Designated as safety issue: Yes] changes in additional body composition parameters (abdominal circumference) [Time Frame: baseline, 16 weeks] [Designated as safety issue: Yes] changes in additional body composition parameters (hip circumference) [Time Frame: baseline, 16 weeks] [Designated as safety issue: Yes] changes in fasting metabolic parameters (Total Cholesterol) [Time Frame: baseline, 16 weeks] [Designated as safety issue: Yes] changes in fasting metabolic parameters (LDL) [Time Frame: baseline, 16 weeks] [Designated as safety issue: Yes] changes in fasting metabolic parameters (HDL) [Time Frame: baseline, 16 weeks] [Designated as safety issue: Yes] changes in fasting metabolic parameters (triglycerides) [Time Frame: baseline, 16 weeks] [Designated as safety issue: Yes] changes in fasting metabolic parameters (glucose) [Time Frame: baseline, 16 weeks] [Designated as safety issue: Yes] changes in fasting metabolic parameters (insulin) [Time Frame: baseline, 16 weeks] [Designated as safety issue: Yes]

Descriptive Information[ + expand ][ + ]

Brief Title	Treatment of Overweight Induced by Antipsychotic Medication in Young People With Autism Spectrum Disorders (ASD)
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	Overweight Autism Spectrum Disorder
Intervention	Drug: Metformin Other Names: Riomet
Study Arm (s)	Placebo Comparator: Placebo Hydrochloride Oral Solution 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 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.

Recruitment Information[ + expand ][ + ]

Recruitment Status	Recruiting
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
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.edu Principal Investigator: Michael Aman, PhD Recruiting
University of Pittsburgh Medical Center	Pittsburgh, Pennsylvania, United States, 15203 Contact: Sarah McAuliffe-Bellin, M.Ed \| 412-235-5447 \| mcausj@upmc.edu Principal Investigator: Benjamin Handen, PhD Recruiting
Vanderbilt University	Nashville, Tennessee, United States, 37212 Contact: Sarah Marler, MA \| 615-936-3288 \| sarah.marler@vanderbilt.edu Principal 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.ca Principal Investigator: Evdokia Anagnostou, MD Recruiting