Serial Comparisons of Abdominal and Neurological MRI Scans (SCANMRI)

December 10, 2015 updated by: University of British Columbia

Serial Comparisons of Abdominal and Neurological MRI Scans of Patients With Refractory Psychosis Disorders

The purpose of this study is to compare abdominal weight gain and fat distribution to changes in brain morphology in people taking antipsychotic medications.

Study Overview

Status

Unknown

Conditions

Detailed Description

Abdominal weight gain is a significant side effect of antipsychotic medications. It has even been suggested to be part of the pathology of severe mental illnesses. Studies have shown that in persons with bipolar disorder, increased body mass index (BMI) is associated with irregular changes in the brain. This association has not been tested in persons with psychosis. In this study, we will be measuring abdominal fat distribution as measured by MRI to see if this is associated with abnormal brain morphology.

Study Type

Observational

Enrollment (Anticipated)

40

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

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 4H4
        • Recruiting
        • BC Mental Health & Addictions Research Institute
        • Contact:
        • Principal Investigator:
          • Alasdair M Barr, Ph.D.
        • Contact:

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

12 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Participants who have recently been seen at the BC (British Columbia) Psychosis Program at the University of British Columbia hospital.

Description

Inclusion Criteria:

  • Must be admitted to the BC (British Columbia) Psychosis Program at UBC (University of British Columbia) Hospital
  • Must have clinically diagnosed psychosis (e.g. schizophrenia)
  • Must be fluent in English
  • Must not be contraindicated for MRI (i.e., must not be claustrophobic, have metal in the body, be pregnant, have BMI greater than or equal to 40, etc.)

Exclusion Criteria:

• None, other than those listed above

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Abdominal distribution of visceral fat versus subcutaneous fat
Time Frame: Baseline (within 2 weeks of admission), 12 weeks later, and prior to discharge
Change over time in amounts of visceral and subcutaneous fat as measured by automated segmentation of a magnetic resonance image (MRI)
Baseline (within 2 weeks of admission), 12 weeks later, and prior to discharge
Changes in total brain volume
Time Frame: Baseline (within 2 weeks of admission), 12 weeks later, and prior to discharge
Change over time in total brain volume as measured by automated segmentation of a magnetic resonance image (MRI).
Baseline (within 2 weeks of admission), 12 weeks later, and prior to discharge
Changes in grey matter volume in the brain
Time Frame: Baseline (within 2 weeks of admission), 12 weeks later, and prior to discharge
Change over time in amounts of brain grey matter as measured by automated segmentation of a magnetic resonance image (MRI).
Baseline (within 2 weeks of admission), 12 weeks later, and prior to discharge
Changes in white matter volume in the brain
Time Frame: Baseline (within 2 weeks of admission), 12 weeks later, and prior to discharge
Change over time in amounts of brain white matter as measured by automated segmentation of a magnetic resonance image (MRI).
Baseline (within 2 weeks of admission), 12 weeks later, and prior to discharge
Changes in the volume of brain structures
Time Frame: Baseline (within 2 weeks of admission), 12 weeks later, and prior to discharge
Change over time in the volume of brain structures as measured by automated segmentation of a magnetic resonance image (MRI).
Baseline (within 2 weeks of admission), 12 weeks later, and prior to discharge

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparing changes in abdominal fat distribution/accumulation to psychosis symptom severity
Time Frame: Baseline (within 2 weeks of admission), 12 weeks later, and prior to discharge
To determine if an association exists between abdominal fat accumulation/distribution and psychosis symptom severity, as measured by the amounts of visceral and subcutaneous fat by automated segmentation of a magnetic resonance image (MRI) and standardized symptom rating scales, cognitive tests, and other neuropsychological examinations, respectively.
Baseline (within 2 weeks of admission), 12 weeks later, and prior to discharge

Collaborators and Investigators

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

Sponsor

University of British Columbia

Investigators

  • Principal Investigator: Alasdair M Barr, Ph.D., The University of British Columbia

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, 2013

Primary Completion (Anticipated)

January 1, 2017

Study Completion (Anticipated)

January 1, 2017

Study Registration Dates

First Submitted

December 9, 2013

First Submitted That Met QC Criteria

December 9, 2013

First Posted (Estimate)

December 12, 2013

Study Record Updates

Last Update Posted (Estimate)

December 14, 2015

Last Update Submitted That Met QC Criteria

December 10, 2015

Last Verified

December 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H13-01685

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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