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White Matter in Pediatric Bipolar Disorder: A DTI Study

This study has been completed.
Sponsor:
Collaborators:
American Academy of Child Adolescent Psychiatry.
Eli Lilly and Company
Information provided by:
Cambridge Health Alliance
ClinicalTrials.gov Identifier:
NCT00391235
First received: October 19, 2006
Last updated: December 2, 2010
Last verified: December 2010
History of Changes
  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

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

Resource links provided by NLM:

U.S. FDA Resources

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 ]

Estimated Enrollment: 28
Study Start Date: September 2005
Study Completion Date: October 2008
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

Locations
United States, Massachusetts
Cambridge Health Alliance
Medford, Massachusetts, United States, 02155
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

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

No publications provided

Responsible Party: Jean Frazier, MD, Cambridge Health Alliance
ClinicalTrials.gov Identifier: NCT00391235     History of Changes
Other Study ID Numbers: CHA-IRB-0132/09/05
Study First Received: October 19, 2006
Last Updated: December 2, 2010
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

Additional relevant MeSH terms:
Bipolar Disorder
Affective Disorders, Psychotic
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on June 18, 2013