Serial Comparisons of Abdominal and Neurological MRI Scans

Psychotic Disorders Clinical Trial

— SCANMRI  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02009969
• Other study ID #: H13-01685
• Status: Recruiting
• Phase: N/A
• First received: December 9, 2013
• Last updated: December 10, 2015
• Start date: September 2013
• Est. completion date: January 2017

Study information

• Verified date: December 2015
• Source: University of British Columbia
• Contact: Heidi N Boyda, Ph.D.
• Phone: 604-875-2000
• Email: hnboyda[@]gmail.com
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: January 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Mental Disorders
• Psychotic Disorders

Locations

Country	Name	City	State
Canada	BC Mental Health & Addictions Research Institute	Vancouver	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
University of British Columbia

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Abdominal distribution of visceral fat versus subcutaneous fat	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	No
Primary	Changes in total brain volume	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	No
Primary	Changes in grey matter volume in the brain	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	No
Primary	Changes in white matter volume in the brain	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	No
Primary	Changes in the volume of brain structures	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	No
Secondary	Comparing changes in abdominal fat distribution/accumulation to psychosis symptom severity	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	No