Side Effect Study of Antipsychotic Medicines to Treat Childhood Bipolar Disorder (PAMS)
The purpose of this study is to learn more about weight gain and related side effects when children are treated with antipsychotic medicine for mood disorders.
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
|Official Title:||Investigating Metabolic Side Effects of Antipsychotic Medications in Children|
- Metabolic parameters [ Time Frame: These measurements will be done at baseline, 3 weeks, 3 months, six months ] [ Designated as safety issue: No ]
- changes in physical activity (using an accelerometer monitor). [ Time Frame: These measurements will also be done at baseline, 3 weeks, 3 months, and six months over the course of treatment. ] [ Designated as safety issue: No ]
|Study Start Date:||June 2008|
|Study Completion Date:||October 2010|
|Primary Completion Date:||October 2010 (Final data collection date for primary outcome measure)|
Children will have a flexible dose titration based on their unique response to the medication (assessed using clinical global improvement scores). Children will be treated for six months using daily, bid dosing.
Other Name: Brand name: Risperdal
children will have a flexible dosing titration based on their unique response (assessed using clinical global improvement scores). Children will be treated with daily medication for six months.
Other Name: Brand name: Abilify
This protocol is a six month, randomized, open label trial of risperidone versus aripiprazole in antipsychotic naive youth (7 - 12 years old) who have been identified by their clinical treatment provider as needing antipsychotic treatment of a bipolar disorder.
This study proposes to monitor changes in metabolic parameters (body mass index percentile, % body fat, insulin resistance, and lipid levels) over the course of six months treatment with aripiprazole or risperidone in youth with a bipolar spectrum disorder. We will also assess possible mechanisms of second generation antipsychotic induced weight gain by monitoring physical activity and hunger/appetite changes over the course of treatment.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00746252
|United States, Maryland|
|University of Maryland, School of Medicine, Department of Psychiatry, Division of Child and Adolescent Psychiatry|
|Baltimore, Maryland, United States, 21201|
|Principal Investigator:||Gloria Reeves, M.D.||University of Maryland, Baltimore County|