White Matter in Pediatric Bipolar Disorder: A DTI Study

This study is currently recruiting participants.

Verified by Cambridge Health Alliance, June 2008

Sponsors and Collaborators:	Cambridge Health Alliance American Academy of Child Adolescent Psychiatry. Eli Lilly and Company
Information provided by:	Cambridge Health Alliance
ClinicalTrials.gov Identifier:	NCT00391235

Purpose

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.

Condition
Bipolar Disorder

MedlinePlus related topics: Bipolar Disorder MRI Scans

U.S. FDA Resources

Study Type:	Observational
Study Design:	Case Control, Prospective
Official Title:	White Matter Connectivity in Pediatric Bipolar Disorder: A Diffusion Tensor Imaging Study

Further study details as provided by Cambridge Health Alliance:

Primary Outcome Measures:

Fractional anisotropy in brain white matter [ Time Frame: Baseline ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	28
Study Start Date:	September 2005
Estimated Study Completion Date:	September 2008
Estimated Primary Completion Date:	September 2008 (Final data collection date for primary outcome measure)

Groups/Cohorts
BPD Children with bipolar disorder
HC Healthy comparison children

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	6 Years to 13 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes
Sampling Method:	Non-Probability Sample

Study Population

Bipolar Disorder

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00391235

Contacts

Contact: Janine Terry

781-306-8630

jterry@challiance.org

Locations

United States, Massachusetts
Cambridge Health Alliance	Recruiting
Medford, Massachusetts, United States, 02155
Contact: Janine Terry, BA 781-306-8630 jterry@challiance.org
Contact: Andrea Yee 781-306-8630 amyee@challiance.org
Sub-Investigator: Melissa Lopez-Larson, MD

Sponsors and Collaborators

Cambridge Health Alliance

American Academy of Child Adolescent Psychiatry.

Eli Lilly and Company

Investigators

Principal Investigator:

Jean A Frazier, MD

Cambridge Health Alliance

More Information

Description of this research program at Cambridge Health Alliance This link exits the ClinicalTrials.gov site

Responsible Party:	Cambridge Health Alliance ( Jean Frazier, MD )
Study ID Numbers:	CHA-IRB-0132/09/05
Study First Received:	October 19, 2006
Last Updated:	June 17, 2008
ClinicalTrials.gov Identifier:	NCT00391235
Health Authority:	United States: Institutional Review Board

Keywords provided by Cambridge Health Alliance:

bipolar disorder
magnetic resonance imaging
white matter

diffusion tensor imaging
children
adolescents

Study placed in the following topic categories:

Affective Disorders, Psychotic
Mental Disorders
Bipolar Disorder
Mood Disorders
Psychotic Disorders

Additional relevant MeSH terms:

Pathologic Processes
Disease

ClinicalTrials.gov processed this record on January 15, 2009