Side Effect Study of Antipsychotic Medicines to Treat Childhood Bipolar Disorder (PAMS)
|ClinicalTrials.gov Identifier: NCT00746252|
Recruitment Status : Completed
First Posted : September 3, 2008
Last Update Posted : June 20, 2012
|Condition or disease||Intervention/treatment|
|Bipolar Disorder||Drug: risperidone Drug: aripiprazole|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Investigating Metabolic Side Effects of Antipsychotic Medications in Children|
|Study Start Date :||June 2008|
|Primary Completion Date :||October 2010|
|Study Completion Date :||October 2010|
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
- Metabolic parameters [ Time Frame: These measurements will be done at baseline, 3 weeks, 3 months, six months ]
- 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. ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|