Strategies to Reduce Antipsychotic-Associated Weight Gain in Youth

• Status: Completed
• Trial end date: 2012-10-01
• Target enrollment: 0
• Participant gender: All

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 prevent or reduce the amount of weight gain and the metabolic changes in adolescent youth typically seen with second-generation antipsychotic medication.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of North Carolina, Chapel Hill
• Collaborator: Foundation of Hope, North Carolina
• Treatments: Antipsychotic Agents; Metformin

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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