Phase 2 Completed N=9 Randomized Quadruple-blind Prevention

Strategies to Reduce Antipsychotic-Associated Weight Gain in Youth

Weight Gain

Source: ClinicalTrials.gov NCT00617240 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Mar 2014

Primary outcomePrimary: Change From Baseline to Week 24 in Body Mass Index (BMI) — 1.620; 1.800 kg/m^2

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Change From Baseline to Week 24 in Body Mass Index (BMI)	1.620; 1.800	—
PRIMARY Change From Baseline to Week 24 in Weight	6.138; 10.45	—
PRIMARY Change From Baseline to Week 24 in Fat Mass	4.770; 8.225	—
SECONDARY Change From Baseline to Week 24 in Insulin Level	1.550; 4.80	—
SECONDARY Change From Baseline to Week 24 in Cholesterol Level	-4.250; -31.00	—
SECONDARY Change From Baseline to Week 24 in Triglycerides	-4.667; -0.5	—
SECONDARY Incidence of Metabolic Syndrome	0; 0	—

Eligibility 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

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Data sourced from ClinicalTrials.gov (NCT00617240). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.