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White Matter in Pediatric Bipolar Disorder: A DTI Study

NCT ID: NCT00391235

Last Updated: 2010-12-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

28 participants

Study Classification

OBSERVATIONAL

Study Start Date

2005-09-30

Study Completion Date

2008-10-31

Brief Summary

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Fourteen subjects with bipolar disorder and 14 matching healthy controls, aged 6-13, will receive a magnetic resonance imaging (MRI) scan on a 3 Tesla scanner. They will also have a clinical interview, including the KSADS-PL. All subjects must be right-handed.

Detailed Description

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We propose to investigate the connectivity of white matter tracts using diffusion tensor imaging (DTI) in children with very early onset bipolar disorder (BPD). We hypothesize that the connectivity between the prefrontal cortex and the temporal lobe and parietal lobe and limbic structures will be abnormal, indicating white matter and gray matter deficits in early onset BPD. We also hypothesize that the superior lateral fasciculus cingulum bundle and the inferior lateral fasciculus will have decreased fractional anisotropy in very early onset BPD relative to healthy controls.

Conditions

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Bipolar Disorder

Keywords

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bipolar disorder magnetic resonance imaging white matter diffusion tensor imaging children adolescents

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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BPD

Children with bipolar disorder

No interventions assigned to this group

HC

Healthy comparison children

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Age 6 to 13
* Male or female
* Right-handed

Exclusion Criteria

* IQ less than 70
* Learning disabilities
* History of autism, schizophrenia, anorexia or bulimia nervosa
* Substance abuse
* Claustrophobia
* Metal in body
* Pregnancy or lactation
Minimum Eligible Age

6 Years

Maximum Eligible Age

13 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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American Academy of Child Adolescent Psychiatry.

OTHER

Sponsor Role collaborator

Eli Lilly and Company

INDUSTRY

Sponsor Role collaborator

Cambridge Health Alliance

OTHER

Sponsor Role lead

Responsible Party

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Cambridge Health Alliance

Principal Investigators

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Jean A Frazier, MD

Role: PRINCIPAL_INVESTIGATOR

Cambridge Health Alliance

Locations

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Cambridge Health Alliance

Medford, Massachusetts, United States

Site Status

Countries

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United States

Related Links

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http://www.cha.harvard.edu/ccad/index.shtml

Description of this research program at Cambridge Health Alliance

Other Identifiers

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CHA-IRB-0132/09/05

Identifier Type: -

Identifier Source: org_study_id