Metformin for Weight Control in Adolescents Taking Atypical Antipsychotics | RxWiki

Metformin for Weight Control in Adolescents Taking Atypical Antipsychotics

Overview[ - collapse ][ - ]

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	Drug Induced Weight Gain
Intervention	Drug: Metformin
Phase	Phase 4
Sponsor	BeerYaakov Mental Health Center
Responsible Party	BeerYaakov Mental Health Center
ClinicalTrials.gov Identifier	NCT00845936
First Received	February 15, 2009
Last Updated	February 18, 2009
Last verified	February 2009

Tracking Information[ + expand ][ + ]

First Received Date	February 15, 2009
Last Updated Date	February 18, 2009
Start Date	May 2009
Estimated Primary Completion Date	May 2010
Current Primary Outcome Measures	Weight loss [Time Frame: 12 weeks] [Designated as safety issue: No]
Current 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]

Descriptive Information[ + expand ][ + ]

Brief Title	Metformin for Weight Control in Adolescents Taking Atypical Antipsychotics
Official Title	Metformin for Weight Control in Adolescents Taking Atypical Antipsychotics- Double Blind Placebo Controlled Study
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 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.
Detailed Description	Not Provided
Study Type	Interventional
Study Phase	Phase 4
Study Design	Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Condition	Drug Induced Weight Gain
Intervention	Drug: Metformin Metformin 850 mg bid
Study Arm (s)	Experimental: 1 850 mg of Metformin bid Placebo Comparator: placebo Tablets Identical to Metformin, bid

Recruitment Information[ + expand ][ + ]

Recruitment Status	Not yet recruiting
Estimated Enrollment	30
Estimated Completion Date	May 2010
Estimated Primary Completion Date	May 2010
Eligibility 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
Gender	Both
Ages	12 Years
Accepts Healthy Volunteers	No
Contacts	Contact: Pazit Leibovich, MD 972-9284065 pazit.leib@gmail.com
Location Countries	Israel

Administrative Information[ + expand ][ + ]

NCT Number	NCT00845936
Other Study ID Numbers	Metformin-38CTIL
Has Data Monitoring Committee	Not Provided
Information Provided By	BeerYaakov Mental Health Center
Study Sponsor	BeerYaakov Mental Health Center
Collaborators	Not Provided
Investigators	Not Provided
Verification Date	February 2009

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