Clinical trial NCT00617058
Conditions: Weight Gain
Keywords: antipsychotic metformin children adolescents
Sponsor: University of North Carolina, Chapel Hill
Start date: 2007-03-01; Completion date: 2010-09-01
Enrollment: 1 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the relative risks and benefits of two approaches to the control of weight gain and other negative side effects in children and adolescents on 2nd generation antipsychotics (SGA):

* Healthy lifestyle instruction (nutritional and physical activity surveillance and advice) + continuation of current SGA;
* Add the diabetes drug, metformin + continuation of current SGA.

Detailed description:
The proposed pilot study is being conducted to obtain pilot data to support a grant application for a multi-site randomized controlled trial. The primary objective is to evaluate the relative risks and benefits of two approaches to the control of weight gain and other negative side effects in children and adolescents on 2nd generation antipsychotics (SGA). The critical question being addressed is: What can be done for the many youth who have gained substantial weight or developed high levels of lipids or glucose in their blood on an SGA; but due to their illness require continued treatment with an antipsychotic?

At least 40 youths (and no more than 60) age 10-17 that have gained substantial weight while taking a frequently used SGA: ziprasidone, aripiprazole or clozapine will be randomized to one of two treatments for 6 months:

* Healthy lifestyle instruction (nutritional and physical activity surveillance and advice) + continuation of current SGA;
* Add the diabetes drug, metformin + continuation of current SGA.
* Subjects may also elect to be in an observational arm that involves no intervention but the same major assessments.

Height, weight, body fat, and various blood tests indicative of general health will be collected during the 6 month trial to monitor the health benefits and safety of the interventions.

SGAs are associated with concerning degrees of weight gain and metabolic consequences. Children and adolescents, in whom SGAs are used increasingly for a wide variety of conditions, are particularly vulnerable to these side effects, which adversely affect health and longevity. It is imperative that researchers evaluate the efficacy and safety of interventions designed to prevent and treat the weight gain and metabolic problems caused by antipsychotic treatment of children. Lifestyle interventions and adjunctive medications all hold some promise of efficacy. However, it is essential that these strategies be rigorously evaluated as soon as possible in order to prevent the ongoing health consequences of SGA treatment in another generation of children with serious psychiatric illnesses.

Arms: arm 1: metformin, 250mg-2000 mg/day, in BID to TID doses for 26 weeks. Open, flexibly adjusted. arm 2: Healthy lifestyle intervention. Additional meeting at each psychiatric visit to review weight changes, level of physical activity and healthy eating behaviors arm 3: Self-selected patients will be followed at major timepoints to assess weight and related measures.
Interventions: intervention 1: metformin intervention 2: healthy lifestyle intervention
Intervention descriptions: intervention 1: open dosed, randomly assigned flexible dose treatment with 250-2000mg/day divided BID or TID intervention 2: additional component to regular psychiatric visits that includes monitoring of lifestyle and eating behaviors.

Protocol documents: