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White Matter in Pediatric Bipolar Disorder: A DTI Study

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ClinicalTrials.gov Identifier: NCT00391235
Recruitment Status : Completed
First Posted : October 23, 2006
Last Update Posted : December 6, 2010
Information provided by:

Study Description
Brief Summary:
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 or disease
Bipolar Disorder

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.

Study Design

Study Type : Observational
Estimated Enrollment : 28 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: White Matter Connectivity in Pediatric Bipolar Disorder: A Diffusion Tensor Imaging Study
Study Start Date : September 2005
Primary Completion Date : September 2008
Study Completion Date : October 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bipolar Disorder
U.S. FDA Resources

Groups and Cohorts

Children with bipolar disorder
Healthy comparison children

Outcome Measures

Primary Outcome Measures :
  1. Fractional anisotropy in brain white matter [ Time Frame: Baseline ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 13 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Bipolar Disorder

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00391235

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
Principal Investigator: Jean A Frazier, MD Cambridge Health Alliance
More Information

Responsible Party: Jean Frazier, MD, Cambridge Health Alliance
ClinicalTrials.gov Identifier: NCT00391235     History of Changes
Other Study ID Numbers: CHA-IRB-0132/09/05
First Posted: October 23, 2006    Key Record Dates
Last Update Posted: December 6, 2010
Last Verified: December 2010

Keywords provided by Cambridge Health Alliance:
bipolar disorder
magnetic resonance imaging
white matter
diffusion tensor imaging

Additional relevant MeSH terms:
Bipolar Disorder
Pathologic Processes
Bipolar and Related Disorders
Mental Disorders