Strategies to Reduce Antipsychotic-Associated Weight Gain in Youth (PREVENT)
The purpose of this pilot study is to determine whether starting metformin in conjunction with a second-generation antipsychotic (SGA) and providing information about healthy eating and activity will prevent or reduce the amount of weight gain and the metabolic changes in adolescent youth typically seen with second-generation antipsychotic medication.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
|Official Title:||Metformin Mitigation of Atypical Antipsychotic-Induced Metabolic Dysregulation in Adolescent Youth|
- Change From Baseline to Week 24 in Body Mass Index (BMI) [ Time Frame: 0-24 weeks ] [ Designated as safety issue: Yes ]Change in BMI-Body Mass Index (BMI) is a measure of body fat based on height, weight,gender and chronological age. Change in BMI is calculated as 24 weeks BMI minus the baseline BMI.
- Change From Baseline to Week 24 in Weight [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]Change in weight is calculated as 24 weeks weight minus the baseline weight.
- Change From Baseline to Week 24 in Fat Mass [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]Fat mass is a measure of excess body fat. Change in Fat Mass is calculated as 24 weeks fat mass minus the baseline fat mass.
- Change From Baseline to Week 24 in Insulin Level [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]Insulin is a peptide hormone and regulates carbohydrate and fat metabolism in the body.Change in Insulin level is calculated as the 24 weeks insulin level minus the baseline insulin level.
- Change From Baseline to Week 24 in Cholesterol Level [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]According to the lipid hypothesis, abnormal cholesterol levels are strongly associated with cardiovascular disease because these promote atherosclerosis.Cholesterol levels are measured in milligrams (mg) of cholesterol per deciliter(dL) of blood.Change in cholesterol levels is measured at 24 weeks minus the levels at baseline.
- Change From Baseline to Week 24 in Triglycerides [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]In the human body, high levels of triglyceride fats in the bloodstream have been linked to atherosclerosis and, by extension, the risk of heart disease and stroke. A change in triglycerides is calculated from 24 weeks minus baseline levels.
- Incidence of Metabolic Syndrome [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]Metabolic syndrome is a combination of the medical disorders that, when co-occurring, increase the risk of developing cardiovascular disease and diabetes.
|Study Start Date:||January 2007|
|Study Completion Date:||October 2012|
|Primary Completion Date:||October 2012 (Final data collection date for primary outcome measure)|
metformin in doses from 250mg to 2000mg/day for 26 weeks
500mg tablets, 250mg to 2000mg/day, po, BID to TID, 26 weeks
Other Name: Glucophage
Placebo Comparator: 2
Matched placebo to metformin, doses between 250/0mg and 2000/0mg per day
500/0mg tablets, 250-2000mg/day divided BID to TID, po, 26 weeks
This is a 24 week, placebo-controlled, random assignment pilot study in which participants will be randomized in a 1:1 ratio to receive either flexible-dose treatment with metformin for 6 months as well as a newly initiated second generation antipsychotic medication or to receive placebo and the newly initiated antipsychotic medication. All subjects will also be provided healthy lifestyle instruction. The study involves monthly visits for the duration of the study. Participants may be treated as inpatients or outpatients throughout the course of the study. Participants will receive a psychiatric evaluation, physical exam, lab work, ECG, medication treatment, and psychiatric care.
The goal is to evaluate the safety and efficacy of means to prevent and treat weight gain and the associated endocrine, metabolic, and inflammatory changes caused by antipsychotic medications. Behavioral treatments to reduce weight gain and metabolic problems after weight gain has occurred have had little impact. Such interventions must be intensive and sustained over months, if not years to be effective. Although basic lifestyle instruction (diet and physical activity) should be the standard of care for all children and adolescents at risk for becoming overweight, pharmacologic interventions may be the best option for substantially augmenting behavioral approaches to weight management.
|United States, North Carolina|
|University of North Carolina, Department of Psychiatry|
|Chapel Hill, North Carolina, United States, 27599|
|Principal Investigator:||Linmarie Sikich, MD||Unversity of North Carolina, Department of Psychiatry|