Side Effect Study of Antipsychotic Medicines to Treat Childhood Bipolar Disorder (PAMS)
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|ClinicalTrials.gov Identifier: NCT00746252|
Recruitment Status : Terminated (Due low rate of participation and lack of funding)
First Posted : September 3, 2008
Results First Posted : March 21, 2018
Last Update Posted : March 21, 2018
|Condition or disease||Intervention/treatment||Phase|
|Bipolar Disorder||Drug: risperidone Drug: aripiprazole||Not Applicable|
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)|
|Actual Enrollment :||5 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|
|Actual Primary Completion Date :||October 2010|
|Actual 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
- Weight Gain [ Time Frame: These measurements are done biweekly from baseline up until 12 weeks ]Weight gain from baseline to last observation up to 12 weeks. Last observation carried to 12 weeks.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|