NCT02083978

Brief Summary

In this proposal, the investigators will focus on subcortical gray and white matter structures commonly found to be abnormal in schizophrenia. Thus, the investigators will evaluate the volume and shape of the hippocampus, thalamus and basal ganglia, as well as measures of structural integrity of the corpus callosum and its various subregions.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
75

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2010

Longer than P75 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

January 1, 2010

Completed
4.2 years until next milestone

First Submitted

Initial submission to the registry

March 7, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 11, 2014

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

June 3, 2015

Status Verified

June 1, 2015

Enrollment Period

4.9 years

First QC Date

March 7, 2014

Last Update Submit

June 1, 2015

Conditions

Keywords

Bipolar DisorderMagnetic Resonance Imaging (MRI) scanning

Outcome Measures

Primary Outcomes (1)

  • subcortical grey and white matter structures

    Evaluation of the volume and shape of the hippocampus, thalamus and basal ganglia, as well as measures of structural integrity of the corpus callosum and its various subregions.

    within one month of study enrollment

Study Arms (2)

Bipolar Diagnosis

Individuals identified as having a Bipolar Diagnosis with a manic episode

Other: MRI scanning

Control

Individuals identified as not having a major psychiatric diagnosis

Other: MRI scanning

Interventions

Bipolar DiagnosisControl

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Community Sample

You may qualify if:

  • between the ages of 18-30
  • diagnosed with Bipolar Disorder

You may not qualify if:

  • history of head injury
  • unstable medical condition

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

MeSH Terms

Conditions

Bipolar Disorder

Condition Hierarchy (Ancestors)

Bipolar and Related DisordersMood DisordersMental Disorders

Study Officials

  • Daniel Mamah, M.D, MPE

    Washington University School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 7, 2014

First Posted

March 11, 2014

Study Start

January 1, 2010

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

June 3, 2015

Record last verified: 2015-06

Locations