Status:
COMPLETED
Strategies to Reduce Antipsychotic-Associated Weight Gain in Youth
Lead Sponsor:
University of North Carolina, Chapel Hill
Collaborating Sponsors:
Foundation of Hope, North Carolina
Conditions:
Weight Gain
Eligibility:
All Genders
10-17 years
Phase:
PHASE2
Brief Summary
The purpose of this pilot study is to determine whether starting metformin in conjunction with a second-generation antipsychotic (SGA) and providing information about healthy eating and activity will ...
Detailed Description
This is a 24 week, placebo-controlled, random assignment pilot study in which participants will be randomized in a 1:1 ratio to receive either flexible-dose treatment with metformin for 6 months as we...
Eligibility Criteria
Inclusion
- Subjects will be between the ages of 10 and 17, male or female, any race or ethnicity
- Any SPMI pediatric diagnosis that meets DSM-IV criteria and frequently is treated with a SGA- typically but not limited to psychotic, mood, pervasive developmental, oppositional defiant, and conduct disorders
- SGA-naïve or less than 2 weeks exposure to any SGA, except ziprasidone
- Legal guardian able and willing to give written informed consent
- If competent, subject able and willing to assent for their own participation
Exclusion
- Previous trial of metformin
- Recommendation for treatment with clozapine or ziprasidone
- Current use of insulin or any oral hypoglycemic agent
- Current use of a medication known to mitigate weight gain - amantidine, histamine (H2) antagonists (cimetidine, ranitidine, nizatidine), topiramate, orlistat, sibutramine, stimulants (dextroamphetamine, methylphenidate)
- Any current or past diagnosis of an eating disorder
- Diabetes mellitus
- Current active thyroid (TSH \>18 microIU/ml; T4 total \>18 mcg/dl), hepatic (2 LFTs \>4x upper limits of normal), renal (serum Creatinine \>1.4 mg/dL in females and serum Creatinine \>1.5 mg/dL in males), cardiac, gastrointestinal, or adrenal disease
- Current substance abuse/dependence within past 2 weeks; a positive urine tox screen at baseline in the absence of meeting criteria for abuse/dependence will not preclude enrollment.
- Pregnancy or breast feeding
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2012
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT00617240
Start Date
January 1 2007
End Date
October 1 2012
Last Update
March 11 2014
Active Locations (1)
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1
University of North Carolina, Department of Psychiatry
Chapel Hill, North Carolina, United States, 27599