Reducing Antipsychotic-Induced Weight Gain in Children With Metformin
Information source: Nationwide Children's Hospital
Information obtained from ClinicalTrials.gov on February 07, 2013
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Obesity; Weight Gain; Psychotropic Induced Weight Gain
Intervention: Metformin (Drug)
Phase: Phase 1
Status: Recruiting
Sponsored by: Nationwide Children's Hospital Official(s) and/or principal investigator(s):
Ihuoma Eneli, MD, Principal Investigator, Affiliation: Nationwide Children's Hospital
Overall contact:
Ihuoma Eneli, MD, MS, Phone: 614-722-4089, Email: ihuoma.eneli@nationwidechildrens.org
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
Clinical Details
Official title: Reducing Antipsychotic-Induced Weight Gain in Children With Metformin
Study design: Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Change in weight
Secondary outcome: Weight trajectory based on length of intervention and factors that predict response to Metformin
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.
Eligibility
Minimum age: 10 Years.
Maximum age: 17 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
1. Children aged 10-17
2. Currently prescribed one of the following psychotropic medications: Haloperidol,
perphenazine, clozapine, olanzapine, risperidone, quetiapine, ziprasidone,
aripiprazole, thioridazine, chlorprothixene, loxapine, mesoridazine, thiothixene or
trifluoperazine.
3. Documented weight gain while on prescribed medications
4. Either >5% weight increase from the start of medication through 3 months on, or
crossing into the 95th percentile for BMI, or crossing into the 85-95th percentile
plus one obesity related complication.
5. Children aged 10-17 years old with BMI >95th percentile and fasting insulin
level>21. 7U/L not currently on psychotropic medications
Exclusion Criteria:
1. History of liver disease
2. History of kidney disease
3. Abnormal creatinine
4. Abnormal liver function blood levels -
Locations and Contacts
Ihuoma Eneli, MD, MS, Phone: 614-722-4089, Email: ihuoma.eneli@nationwidechildrens.org
Nationwide Children's Hospital, Columbus, Ohio 43205, United States; Recruiting
Ihuoma Eneli, MD, MS, Phone: 614-722-4089, Email: ihuoma.eneli@nationwidechildrens.org
Mary Ann Murphy, MD, PhD, Phone: 614-722-2291, Email: maryann.murphy@nationwidechildrens.org
Additional Information
Starting date: February 2010
Last updated: October 29, 2010
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