Metformin for Weight Control in Adolescents Taking Atypical Antipsychotics

Sponsor

BeerYaakov Mental Health Center (Other)

Overall Status

Unknown status

CT.gov ID

NCT00845936

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

2.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Identify a medication capable of reducing or preventing weight gain by an AA agent.
Identify an agent capable of improving compliance due to lower side-effect profile of AAs.

Condition or Disease	Intervention/Treatment	Phase
Drug Induced Weight Gain	Drug: Metformin	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Metformin for Weight Control in Adolescents Taking Atypical Antipsychotics- Double Blind Placebo Controlled Study

Study Start Date :

May 1, 2009

Anticipated Primary Completion Date :

May 1, 2010

Anticipated Study Completion Date :

May 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 850 mg of Metformin bid	Drug: Metformin Metformin 850 mg bid
Placebo Comparator: placebo Tablets Identical to Metformin, bid	Drug: Metformin Metformin 850 mg bid

Arm

Intervention/Treatment

Experimental: 1

850 mg of Metformin bid

Drug: Metformin

Metformin 850 mg bid

Placebo Comparator: placebo

Tablets Identical to Metformin, bid

Drug: Metformin

Metformin 850 mg bid

Outcome Measures

Primary Outcome Measures

Weight loss [12 weeks]

Secondary Outcome Measures

BMI, Weist circumstance, Blood pressure,Blood cholesterol,Fasting blood glucose and Insulin, Leptin levels. For safety- B12, Folate, lactate [12 weeks]