Serial Comparisons of Abdominal and Neurological MRI Scans

NCT02009969 | Unknown

• 1 other identifier: H13-01685
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Psychotic Disorders

Keywords

Psychosis; Adverse effects; Symptom Severity; Magnetic Resonance Imaging

Outcome Measures

Primary Outcomes (5)

• 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

• 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

• 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

• 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

• 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

Secondary Outcomes (1)

• Comparing changes in abdominal fat distribution/accumulation to psychosis symptom severity

  Baseline (within 2 weeks of admission), 12 weeks later, and prior to discharge

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.)

You may not qualify if:

• None, other than those listed above

Sponsors & Collaborators

• University of British Columbia: lead

Study Sites (1)

BC Mental Health & Addictions Research Institute

Vancouver, British Columbia, V5Z 4H4, Canada

RECRUITING

MeSH Terms

Conditions

Psychotic Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Officials

• Alasdair M Barr, Ph.D.

  The University of British Columbia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Heidi N Boyda, Ph.D.

CONTACT

604-875-2000; hnboyda@gmail.com

Delrae Fawcett, M.Sc.

CONTACT

604-875-2000; delrae.fawcett@ubc.ca

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2013
• First Posted: December 12, 2013
• Study Start: September 1, 2013
• Primary Completion: January 1, 2017
• Study Completion: January 1, 2017
• Last Updated: December 14, 2015

Record last verified: 2015-12

Locations

CA (1)