White Matter in Pediatric Bipolar Disorder: A DTI Study

Bipolar Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00391235
• Other study ID #: CHA-IRB-0132/09/05
• Status: Completed
• Phase: N/A
• First received: October 19, 2006
• Last updated: December 2, 2010
• Start date: September 2005
• Est. completion date: October 2008

Study information

• Verified date: December 2010
• Source: Cambridge Health Alliance
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: October 2008
• Est. primary completion date: September 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 6 Years to 13 Years

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Bipolar Disorder

Locations

Country	Name	City	State
United States	Cambridge Health Alliance	Medford	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
Cambridge Health Alliance	American Academy of Child Adolescent Psychiatry., Eli Lilly and Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fractional anisotropy in brain white matter		Baseline	No