Psychotic DisordersSCANMRINCT02009969
Serial Comparisons of Abdominal and Neurological MRI Scans
An observational study of Psychotic Disorders, run by University of British Columbia at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Psychotic Disorders
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2013to Jan 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Participants who have recently been seen at the BC (British Columbia) Psychosis Program at the University of British Columbia hospital.
Who may be able to join
- 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.)
Who cannot join
- None, other than those listed above
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
BC Mental Health & Addictions Research Institute
Vancouver, British Columbia, V5Z 4H4
Heidi N Boyda, Ph.D., 604-875-2000 ext. 6484, hnboyda@gmail.com
Delrae Fawcett, M.Sc., 604-875-2000 ext. 6115, delrae.fawcett@ubc.ca
About this study
Official title: 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.
Read the 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.
- Conditions
- Psychotic Disorders
- Keywords
- Psychosis, Adverse effects, Symptom Severity, Magnetic Resonance Imaging
- Medical subject headings
- Psychotic Disorders
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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
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.
Measured: Baseline (within 2 weeks of admission), 12 weeks later, and prior to discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2013 (estimated)
- Study startSep 2013
- Primary completionJan 2017 (estimated)
- Study completionJan 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychotic DisordersStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alasdair M Barr, Ph.D., Principal investigator, The University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02009969
- Sponsor's protocol ID
- H13-01685
- Acronym
- SCANMRI
- Status last verified
- Dec 2015
- First submitted
- 9 Dec 2013
- Last updated
- 14 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serial Comparisons of Abdominal and Neurological MRI Scans of Patients With Refractory Psychosis Disorders
- ClinicalTrials.gov ID
- NCT02009969
- Acronym / sponsor ID
- SCANMRI / H13-01685
- Conditions
- Psychotic Disorders
- Keywords
- Psychosis, Adverse effects, Symptom Severity, Magnetic Resonance Imaging
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Jan 2017 (estimated)
- Study completion
- Jan 2017 (estimated)
- First posted
- 12 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Participants who have recently been seen at the BC (British Columbia) Psychosis Program at the University of British Columbia hospital.
Key inclusion criteria (4 listed)
- 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.)
Key exclusion criteria (1 listed)
- None, other than those listed above
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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)
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).
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).
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).
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).
1 secondary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alasdair M Barr, Ph.D. principal investigator
The University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Psychotic Disorders, run by University of British Columbia at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Heidi N Boyda, Ph.D. (604-875-2000 ext. 6484, hnboyda@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Abdominal distribution of visceral fat versus subcutaneous fat (time frame: Baseline (within 2 weeks of admission), 12 weeks later, and prior to discharge). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Dec 2015.