NCT00391235

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2005

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2005

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

October 19, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 23, 2006

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2008

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2008

Completed
Last Updated

December 6, 2010

Status Verified

December 1, 2010

Enrollment Period

3 years

First QC Date

October 19, 2006

Last Update Submit

December 2, 2010

Conditions

Bipolar Disorder

Keywords

bipolar disordermagnetic resonance imagingwhite matterdiffusion tensor imagingchildrenadolescents

Outcome Measures

Primary Outcomes (1)

  • Fractional anisotropy in brain white matter

    Baseline

Study Arms (2)

BPD

Children with bipolar disorder

HC

Healthy comparison children

Eligibility Criteria

Age6 Years - 13 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Bipolar Disorder

You may qualify if:

  • Age 6 to 13
  • Male or female
  • Right-handed

You may not qualify if:

  • IQ less than 70
  • Learning disabilities
  • History of autism, schizophrenia, anorexia or bulimia nervosa
  • Substance abuse
  • Claustrophobia
  • Metal in body
  • Pregnancy or lactation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cambridge Health Alliance

Medford, Massachusetts, 02155, United States

Location

Related Links

MeSH Terms

Conditions

Bipolar Disorder

Condition Hierarchy (Ancestors)

Bipolar and Related DisordersMood DisordersMental Disorders

Study Officials

  • Jean A Frazier, MD

    Cambridge Health Alliance

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 19, 2006

First Posted

October 23, 2006

Study Start

September 1, 2005

Primary Completion

September 1, 2008

Study Completion

October 1, 2008

Last Updated

December 6, 2010

Record last verified: 2010-12

Locations

US(1)