Clinical trial NCT02009969: Serial Comparisons of Abdominal and Neurological MRI Scans
Official title: Serial Comparisons of Abdominal and Neurological MRI Scans of Patients With Refractory Psychosis Disorders
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Psychotic Disorders
Keywords: Psychosis
Adverse effects
Symptom Severity
Magnetic Resonance Imaging
Lead sponsor: University of British Columbia
Sponsor class: OTHER
First posted: 2013-12-12
Enrollment: 40
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Abdominal distribution of visceral fat versus subcutaneous fat
timeFrame: Baseline (within 2 weeks of admission), 12 weeks later, and prior to discharge
measure: Changes in total brain volume
timeFrame: Baseline (within 2 weeks of admission), 12 weeks later, and prior to discharge
measure: Changes in grey matter volume in the brain
timeFrame: Baseline (within 2 weeks of admission), 12 weeks later, and prior to discharge
measure: Changes in white matter volume in the brain
timeFrame: Baseline (within 2 weeks of admission), 12 weeks later, and prior to discharge
measure: Changes in the volume of brain structures
timeFrame: Baseline (within 2 weeks of admission), 12 weeks later, and prior to discharge
Secondary outcomes:
measure: Comparing changes in abdominal fat distribution/accumulation to psychosis symptom severity
timeFrame: Baseline (within 2 weeks of admission), 12 weeks later, and prior to discharge
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: BC Mental Health & Addictions Research Institute
state: British Columbia
Study officials:
affiliation: The University of British Columbia
name: Alasdair M Barr, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: