Drug Induced Weight Gain Clinical Trial
Official title:
Metformin for Weight Control in Adolescents Taking Atypical Antipsychotics- Double Blind Placebo Controlled Study
Atypical antipsychotics (AA) are broadly used to treat a variety of psychiatric and
neurological disorders in children and adolescents. Weight gain is a common side effect of
these drugs. AA induced weight gain can be the cause of the metabolic syndrome which is a
major health concern, as well as cancer and significant psychological disorders. Weight gain
may also lead to low compliance with AAs.
A number of studies have been conducted in order to find a way to prevent, reduce or reverse
AA induced weight gain in children and adolescents, but so far there is no commonly accepted
treatment for the problem.
Metformin is an antihyperglycemic drug, approved by the FDA for treatment of type 2 diabetes
in children older than 10 years of age. The drug usually does not cause hypoglycemia, even
in high dosage. Contraindications include renal impairment, hepatic disease, a past history
of lactic acidosis (of any cause), cardiac failure requiring pharmacological therapy, or
chronic hypoxic lung disease. The drug also should be discontinued temporarily prior to the
administration of intravenous contrast media and prior to any surgical procedure. The
reported incidence of lactic acidosis during metformin treatment is less than 0.1 cases per
1000 patient-years, and the mortality risk is even lower.
Acute side effects of metformin, which occur in up to 20% of patients, include diarrhea,
abdominal discomfort, nausea, metallic taste, and anorexia. These usually can be minimized
by increasing the dosage of the drug slowly, when indicated, and taking it with meals.
Intestinal absorption of vitamin B 12 and folate often is decreased during chronic metformin
therapy, and calcium supplements reverse the effect of metformin on vitamin B12 absorption.
Three studies have studied the effect of metformin on weight gain secondary to use of AAs in
adults and 3 other studies studied the effect of metformin in children and adolescents. Most
of these studies have proved the drug to be efficient. No serious side effects have been
demonstrated in any of these studies.
Objective- To assess the effect of metformin on body weight of children and adolescents
treated by AAs.
Setting- recruitment and follow up would take place in the pediatric ward and outpatient
clinic at the Ness- Tziona Mental Health Center.
Participants- 30 adolescents aged 12- 20 years old, treated with AAs, who are overweight as
defined by more than 10% of what is expected according to age and height.
Importance of the Study
1. Identify a medication capable of reducing or preventing weight gain by an AA agent.
2. Identify an agent capable of improving compliance due to lower side-effect profile of
AAs.
| Status | Not yet recruiting |
| Enrollment | 30 |
| Est. completion date | May 2010 |
| Est. primary completion date | May 2010 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 12 Years to 20 Years |
| Eligibility |
Inclusion Criteria: - 12-20 year olds treated by atypical antipsychotics - weight gain of more than 10% than expected for age - Overweight of more than 10% than expected for age and height Exclusion Criteria: - Physical conditions requiring pharmacological treatment - Changes in drug type or dosage 2 months before the trial, except for 25% changes in dosage |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Israel | Beer-Yaacov MHC | Beer Yaacov |
| Lead Sponsor | Collaborator |
|---|---|
| BeerYaakov Mental Health Center |
Israel,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Weight loss | 12 weeks | No | |
| Secondary | BMI, Weist circumstance, Blood pressure,Blood cholesterol,Fasting blood glucose and Insulin, Leptin levels. For safety- B12, Folate, lactate | 12 weeks | No |