White Matter in Pediatric Bipolar Disorder: A DTI Study

December 2, 2010 updated by: Cambridge Health Alliance

White Matter Connectivity in Pediatric Bipolar Disorder: A Diffusion Tensor Imaging Study

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Anticipated)

28

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 13 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Bipolar Disorder

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
BPD
Children with bipolar disorder
HC
Healthy comparison children

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Fractional anisotropy in brain white matter
Time Frame: Baseline
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cambridge Health Alliance

Collaborators

Eli Lilly and Company
American Academy of Child Adolescent Psychiatry.

Investigators

  • Principal Investigator: Jean A Frazier, MD, Cambridge Health Alliance

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2005

Primary Completion (Actual)

September 1, 2008

Study Completion (Actual)

October 1, 2008

Study Registration Dates

First Submitted

October 19, 2006

First Submitted That Met QC Criteria

October 19, 2006

First Posted (Estimate)

October 23, 2006

Study Record Updates

Last Update Posted (Estimate)

December 6, 2010

Last Update Submitted That Met QC Criteria

December 2, 2010

Last Verified

December 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHA-IRB-0132/09/05

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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