Serial Comparisons of Abdominal and Neurological MRI Scans

• Conditions: Psychotic Disorders

• Registration Number: NCT02009969
• Lead Sponsor: University of British Columbia

Brief Summary

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

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 Timeline

• Study Start: 2013-09
• Study First Submitted: 2013-12-09
• Study First Submitted QC: 2013-12-09
• Study First Posted: 2013-12-12
• Status Verified: 2015-12
• Last Update Submitted: 2015-12-10
• Last Update Posted: 2015-12-14
• Primary Completion: 2017-01
• Study Completion: 2017-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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.)

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Exclusion Criteria

• None, other than those listed above

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Abdominal distribution of visceral fat versus subcutaneous fat	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)
Changes in total brain volume	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).
Changes in grey matter volume in the brain	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).
Changes in white matter volume in the brain	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).
Changes in the volume of brain structures	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).

Secondary Outcome Measures

Name	Time	Method
Comparing changes in abdominal fat distribution/accumulation to psychosis symptom severity	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.

Trial Locations

Locations (1)

BC Mental Health & Addictions Research Institute; 🇨🇦 Vancouver, British Columbia, Canada