Status:
COMPLETED
Reducing Antipsychotic-Induced Weight Gain in Children With Metformin
Lead Sponsor:
Nationwide Children's Hospital
Conditions:
Obesity
Weight Gain
Eligibility:
All Genders
10-17 years
Phase:
PHASE1
Brief Summary
Recent but limited short term studies have shown that Metformin can slow down weight gain in obese children and in children with psychotropic-induced weight gain, two distinct pediatric populations th...
Detailed Description
Approximately 21 percent of children, 12-17 years old are diagnosed with DSM IV disorders, with 11 percent exhibiting severe impairment and 5 percent severe emotional difficulties. By 18 years, 1-5 pe...
Eligibility Criteria
Inclusion
- Children aged 10-17
- Currently prescribed one of the following psychotropic medications: Haloperidol, perphenazine, clozapine, olanzapine, risperidone, quetiapine, ziprasidone, aripiprazole, thioridazine, chlorprothixene, loxapine, mesoridazine, thiothixene or trifluoperazine.
- Documented weight gain while on prescribed medications
- Either \>5% weight increase from the start of medication through 3 months on, or crossing into the 95th percentile for BMI, or crossing into the 85-95th percentile plus one obesity related complication.
- Children aged 10-17 years old with BMI \>95th percentile and fasting insulin level\>21.7U/L not currently on psychotropic medications
Exclusion
- History of liver disease
- History of kidney disease
- Abnormal creatinine
- Abnormal liver function blood levels -
Key Trial Info
Start Date :
February 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2013
Estimated Enrollment :
96 Patients enrolled
Trial Details
Trial ID
NCT01231074
Start Date
February 1 2010
End Date
May 1 2013
Last Update
January 2 2019
Active Locations (1)
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1
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205