Status:
COMPLETED
Spectroscopy in Children and Adolescents With Bipolar Disorder
Lead Sponsor:
Massachusetts General Hospital
Collaborating Sponsors:
Janssen Pharmaceutica
Conditions:
Bipolar Disorder
ADHD
Eligibility:
All Genders
6-17 years
Brief Summary
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 ch...
Detailed Description
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...
Eligibility Criteria
Inclusion
- Male or female subjects, 6-17 years of age
- Subject and parent must have a level of understanding sufficient to communicate intelligently with the investigator and study coordinator, and to cooperate with all tests and examinations required by the protocol
- Subjects and their legal representatives must be considered reliable
- Each subject and his/her authorized legal representative must understand the nature of the study. The subject's authorized legal representative must sign an informed consent document and the subject must sign an informed assent document.
- Bipolar subjects must have a diagnosis of bipolar I or bipolar II disorder with a lifetime manic or mixed episode (with or without psychotic features) according to the DSM-IV confirmed by structured diagnostic interview (KSADS)
- ADHD subjects must meet full criteria for ADHD (with or without hyperactivity) according to the DSM-IV confirmed by structured diagnostic interview (KSADS)
Exclusion
- Investigator and his/her immediate family; defined as the investigator's spouse, parent, child, grandparent, or grandchild.
- Pregnant of nursing females
- Presence of metal or surgical devices (aneurysm clips, metal plates, cochlear implants, neurostimulators, braces, and other items) in vital areas.
- Severe phobia of being in small, enclosed spaces (claustrophobic)
- Bipolar subjects must either have been free of antipsychotic medication (including risperidone) for 3 months of longer OR be currently treated with risperidone for 8 weeks or longer.
- ADHD subjects must not meet criteria for bipolar disorder by structured interview (KSADS). These subjects must be free of antipsychotic medication for 3 months or longer).
- Control subjects must not meet criteria for ADHD or bipolar disorder by structured interview (KSADS). These subjects must be free of antipsychotic medication treatment for 3 months or longer.
- Left hand dominant subjects will be excluded
Key Trial Info
Start Date :
December 1 2002
Trial Type :
OBSERVATIONAL
End Date :
November 1 2005
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT00181831
Start Date
December 1 2002
End Date
November 1 2005
Last Update
June 13 2013
Active Locations (1)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114