- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02083978
Bipolar Research Study Using MR Imaging
June 1, 2015 updated by: Washington University Early Recognition Center
Neuromorphometry of Psychosis in Bipolar Disorder
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.
Study Overview
Detailed Description
There are relatively few studies evaluating brain structure in bipolar disorder (BD), the results of which have been largely inconsistent, both in terms of what abnormalities are present in BD and whether they show any similar abnormalities to those found in schizophrenia.
One possibility that might explain the varying degree of reported similarity in structural findings in schizophrenia and BD is that there might be effects of BPD diagnostic subtype associated with brain structure.
One viewpoint that contrasts schizophrenia and BD considers psychotic (PBD) to differ from non-psychotic (NPBD) subtypes in terms of shared pathophysiology with schizophrenia.
PBD has been reported as being of special interest, as it shares symptomatic overlap with schizophrenia, "runs in families", shares a chromosomal linkage to the 13q13-32 and 22q12 with schizophrenia, shows similar increases in dopamine receptor Bmax induced by [c-11] N-methylspiperone positron emission tomography and similar working memory impairments as in schizophrenia.
If PBP and NPBP are associated with different forms of brain pathology, then merging the two entities into a single "bipolar group" might obscure relevant anatomic differences if these occur primarily in only one group.
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.
Study Type
Observational
Enrollment (Actual)
75
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
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Missouri
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St. Louis, Missouri, United States, 63110
- Washington University School of Medicine
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-
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
18 years to 30 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Community Sample
Description
Inclusion Criteria:
- between the ages of 18-30
- diagnosed with Bipolar Disorder
Exclusion Criteria:
- history of head injury
- unstable medical condition
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 |
Intervention / Treatment |
|---|---|
|
Bipolar Diagnosis
Individuals identified as having a Bipolar Diagnosis with a manic episode
|
|
|
Control
Individuals identified as not having a major psychiatric diagnosis
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
subcortical grey and white matter structures
Time Frame: within one month of study enrollment
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Daniel Mamah, M.D, MPE, Washington University School of Medicine
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
January 1, 2010
Primary Completion (Actual)
December 1, 2014
Study Completion (Actual)
December 1, 2014
Study Registration Dates
First Submitted
March 7, 2014
First Submitted That Met QC Criteria
March 10, 2014
First Posted (Estimate)
March 11, 2014
Study Record Updates
Last Update Posted (Estimate)
June 3, 2015
Last Update Submitted That Met QC Criteria
June 1, 2015
Last Verified
June 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 201105453
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.