Reducing Antipsychotic-Induced Weight Gain in Children With Metformin
Condition: Obesity; Weight Gain; Psychotropic Induced Weight Gain
MeSH terms: Body Weight; Weight Gain
Study type: Interventional
Phase: Phase 1

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 that are at risk for obesity related co-morbid conditions. The purpose of this
      study is to conduct a long term prospective pilot cohort study to investigate the use of
      Metformin to prevent or decrease weight gain in two cohorts of children: 1) children with
      psychotropic induced weight gain on Metformin and 2) children with BMI above the 95th
      percentile on Metformin. Both study populations will be enrolled in a lifestyle weight
      management program
    

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 percent of children are diagnosed with bipolar disorder and up to 20 percent of
      children with depression. As greater numbers of children and adolescents have been diagnosed
      with these disorders in the last 10 years, the use of psychotropic drugs in the pediatric
      populations has increased. Many of the drugs prescribed are the newer antipsychotic drugs
      olanzapine, risperidone, and quetiapine, referred to as atypical antipsychotics. Compared to
      the older drugs, such as haldol and thorazine, atypical antipsychotics boast an improved
      safety profile, with fewer side effects such as tardive dyskinesia, extrapyramidal symptoms
      and hyperprolactinemia. This advantage has led to providers prescribing antipsychotic more
      frequently not only for psychotic conditions, but also for other behavioral problems, eg.,
      oppositional defiant disorder, mood disorders, and autism spectrum disorders. In many ways,
      these medicines are life saving. They protect children from the fate of psychosis, unchecked
      rage and agitation, allowing the them a chance to grow up more normally.

      Our study will provide preliminary evidence for the feasibility of using metformin as an
      adjunct for weight management in two vulnerable pediatric populations. We will apply for
      external funding for a large scale randomized clinical trial that will test efficacy of
      metformin in both our study populations with appropriate comparison groups. In addition,
      results from our exploratory analysis of patient characteristics eg., insulin level, eating
      behaviors) that may affect response to treatment will provide a basis to generate further
      hypothesis for mechanism of action.

      Primary objective: Describe and compare the pattern of changes in weight trajectory in the
      (PIW) and (OME) group.

      Secondary Objective: To conduct a preliminary investigation of factors(Baseline BMI,
      adherence, presence of gastrointestinal side effects, HOMA-IR, eating patterns) that
      influence the response to metformin.
    

Intervention name(s): Metformin
Intervention type(s): Drug
Intervention description(s): Metformin dosing will be done as is typical in clinical practice. Doses will be titrated at 500mg daily for one week, to a maximum dose of 1000mg twice a day as tolerated by subject.
Other intervention name(s): glucophage; fortamet; glucophage xr; glumetza; riomet
Intervention MeSH terms: Metformin
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: obesity; weight gain; metformin; psychotropic drugs