Metformin for Weight Control in Adolescents Taking Atypical Antipsychotics

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2009 by BeerYaakov Mental Health Center.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
BeerYaakov Mental Health Center
ClinicalTrials.gov Identifier:
NCT00845936
First received: February 15, 2009
Last updated: February 18, 2009
Last verified: February 2009
  Purpose

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.

Condition Intervention Phase
Drug Induced Weight Gain
Drug: Metformin
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Metformin for Weight Control in Adolescents Taking Atypical Antipsychotics- Double Blind Placebo Controlled Study

Resource links provided by NLM:


Further study details as provided by BeerYaakov Mental Health Center:

Primary Outcome Measures:
  • Weight loss [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • BMI, Weist circumstance, Blood pressure,Blood cholesterol,Fasting blood glucose and Insulin, Leptin levels. For safety- B12, Folate, lactate [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: May 2009
Estimated Study Completion Date: May 2010
Estimated Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   12 Years to 20 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00845936

Contacts
Contact: Pazit Leibovich, MD 972-9284065 pazit.leib@gmail.com

Locations
Israel
Beer-Yaacov MHC Not yet recruiting
Beer Yaacov, Israel, 70350
Contact: Pazit Leibovich, MD    972-9284065    pazit.leib@gmail.com   
Sub-Investigator: Pazit Leibovich, MD         
Sponsors and Collaborators
BeerYaakov Mental Health Center
  More Information

No publications provided

Responsible Party: Pazit Leibovich, MD, BeerYaakov Mental Health Center
ClinicalTrials.gov Identifier: NCT00845936     History of Changes
Other Study ID Numbers: Metformin-38CTIL
Study First Received: February 15, 2009
Last Updated: February 18, 2009
Health Authority: Israel: health Administration

Keywords provided by BeerYaakov Mental Health Center:
Atypical antipsychotics
Weight
adolecsents
pediatric
Metformin

Additional relevant MeSH terms:
Weight Gain
Body Weight Changes
Body Weight
Signs and Symptoms
Metformin
Antipsychotic Agents
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Tranquilizing Agents
Central Nervous System Depressants
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs

ClinicalTrials.gov processed this record on July 24, 2014