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Sponsored by: |
University of Maryland |
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Information provided by: | University of Maryland |
ClinicalTrials.gov Identifier: | NCT00746252 |
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.
Condition | Intervention |
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Bipolar Disorder |
Drug: risperidone Drug: aripiprazole |
Study Type: | Interventional |
Study Design: | Randomized, Open Label, Parallel Assignment |
Official Title: | Investigating Metabolic Side Effects of Antipsychotic Medications in Children |
Estimated Enrollment: | 40 |
Study Start Date: | June 2008 |
Estimated Study Completion Date: | July 2012 |
Estimated Primary Completion Date: | July 2012 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
risperidone
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Drug: risperidone
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.
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2: Experimental
aripiprazole
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Drug: aripiprazole
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.
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This protocol is a six month, randomized, open label trial of risperidone versus aripiprazole in antipsychotic naive youth (8 - 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.
Ages Eligible for Study: | 8 Years to 12 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Specific diagnoses included are as follows:
Exclusion Criteria:
Medications: We will exclude children who are on current treatment with
Contact: Gloria Reeves, M.D. | (410)328-6822 | GREEVES@PSYCH.UMARYLAND.EDU |
United States, Maryland | |
University of Maryland, School of Medicine, Department of Psychiatry, Division of Child and Adolescent Psychiatry | Recruiting |
Baltimore, Maryland, United States, 21201 | |
Principal Investigator: Gloria Reeves, M.D. |
Principal Investigator: | Gloria Reeves, M.D. | University of Maryland |
Responsible Party: | University of Maryland ( Gloria Reeves, M.D., principal investigator ) |
Study ID Numbers: | H-28645 |
Study First Received: | September 2, 2008 |
Last Updated: | September 2, 2008 |
ClinicalTrials.gov Identifier: | NCT00746252 |
Health Authority: | United States: Food and Drug Administration |
bipolar children antipsychotic side effect |
Affective Disorders, Psychotic Dopamine Mental Disorders Bipolar Disorder Risperidone |
Mood Disorders Psychotic Disorders Aripiprazole Serotonin |
Neurotransmitter Agents Disease Tranquilizing Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Psychotropic Drugs Central Nervous System Depressants Dopamine Antagonists |
Antipsychotic Agents Pharmacologic Actions Serotonin Antagonists Pathologic Processes Serotonin Agents Therapeutic Uses Dopamine Agents Central Nervous System Agents |