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Sponsors and Collaborators: |
Massachusetts General Hospital Janssen Pharmaceutica N.V., Belgium |
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Information provided by: | Massachusetts General Hospital |
ClinicalTrials.gov Identifier: | NCT00181831 |
The primary aim of this study is to use proton magnetic resonance spectroscopy to look at myo-Inositol containing compounds (Ino) and creatine + phosphocreatine (Cr) in the anterior cingulate of 20 children with bipolar disorder between the ages of 6-17 years old free of risperidone treatment and 20 children with bipolar disorder after an eight-week or longer treatment with risperidone. For comparison, results will also be obtained from 20 controls (without bipolar disorder or ADHD) of the same age and gender as well as from 20 children or adolescents with a diagnosis of Attention Deficit Hyperactivity Disorder. We hypothesize that Ino/Cr levels in the anterior cingulate will correlate positively with manic symptoms using the Young mania rating scale (YMRS). Ino/Cr levels in the anterior cingulate in the anterior cingular gyrus will be lower in subjects who have received eight weeks or longer of risperidone
Condition | Intervention |
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Bipolar Disorder ADHD |
Device: Proton Magnetic Resonance Spectroscopy |
Study Type: | Observational |
Study Design: | Prospective |
Official Title: | Proton Magnetic Resonance Spectroscopy in Children and Adolescents With Bipolar Disorder |
Estimated Enrollment: | 80 |
Study Start Date: | December 2002 |
Study Completion Date: | November 2005 |
Choline containing compound (Cho) and creatine + phosphocreatine (Cr) have been found to be greater in the orbitofrontal cortex of depressed adolescents. In addition, Cho/Cr has been found to increase in the anterior cingulate in depressed patients with bipolar affective disorder (BPD) compared with comparison subjects. Also, BPD subjects not taking antidepressants had a significantly higher anterior cingulate Cho/Cr compared with subjects taking antidepressants or comparison subjects. Therefore it would appear the frontal lobe Cho/Cr is increased in depression. Given these findings, we are interested in looking at subjects with mania to investigate if there may also be a biological marker for mania and drug response. Mania measured using the YMRS have been associated with an increase in the anterior cingulate Ino/Cr in manic children, adolescents, and adults with bipolar affective disorder. In addition, children and adolescents who were responsive to lithium showed a decrease in Ino/Cr levels after acute lithium treatment. We will test whether Ino/Cr levels will correlate positively with manic symptoms using the YMRS, as well as whether overall Ino/Cr levels will be lower for children and adolescents receiving risperidone.
The primary aim of this study is to use proton magnetic resonance spectroscopy to look at myo-Inositol containing compounds (Ino) and creatine + phosphocreatine (Cr) in the anterior cingulate of 20 children with bipolar disorder between the ages of 6-17 years old free of risperidone treatment and 20 children with bipolar disorder after an eight-week or longer treatment with risperidone. For comparison, results will also be obtained from 20 controls (without bipolar disorder or ADHD) of the same age and gender as well as from 20 children or adolescents with a diagnosis of Attention Deficit Hyperactivity Disorder. We hypothesize that Ino/Cr levels in the anterior cingulate will correlate positively with manic symptoms using the Young mania rating scale (YMRS). Ino/Cr levels in the anterior cingulate in the anterior cingular gyrus will be lower in subjects who have received eight weeks or longer of risperidone
Ages Eligible for Study: | 6 Years to 17 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
20 children with bipolar disorder between the ages of 6-17 years old free of risperidone treatment and 20 children with bipolar disorder after an eight-week or longer treatment with risperidone.
Inclusion Criteria:
Exclusion Criteria:
United States, Massachusetts | |
Massachusetts General Hospital | |
Cambridge, Massachusetts, United States, 02138 |
Principal Investigator: | Joseph Biederman, MD | Massachusetts General Hospital |
Responsible Party: | Massachusetts General Hospital ( Joseph Biederman, MD ) |
Study ID Numbers: | 2002-P-000661 |
Study First Received: | September 13, 2005 |
Last Updated: | July 3, 2008 |
ClinicalTrials.gov Identifier: | NCT00181831 |
Health Authority: | United States: Food and Drug Administration |
SPECT bipolar disorder ADHD children |
Affective Disorders, Psychotic Mental Disorders Bipolar Disorder Mood Disorders Psychotic Disorders |
Pathologic Processes Disease |