Serial Comparisons of Abdominal and Neurological MRI Scans (SCANMRI)

December 10, 2015 updated by: University of British Columbia

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

  • Name: Heidi N Boyda, Ph.D.
  • Phone Number: 6484 604-875-2000
  • Email: hnboyda@gmail.com

Study Locations

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 4H4
        • Recruiting
        • BC Mental Health & Addictions Research Institute
        • Contact:
        • Principal Investigator:
          • Alasdair M Barr, Ph.D.
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

12 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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)
Baseline (within 2 weeks of admission), 12 weeks later, and prior to discharge
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).
Baseline (within 2 weeks of admission), 12 weeks later, and prior to discharge
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).
Baseline (within 2 weeks of admission), 12 weeks later, and prior to discharge
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).
Baseline (within 2 weeks of admission), 12 weeks later, and prior to discharge
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).
Baseline (within 2 weeks of admission), 12 weeks later, and prior to discharge

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of British Columbia

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Alasdair M Barr, Ph.D., The University of British Columbia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2013

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2017

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 9, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 9, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 12, 2013

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 14, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 10, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • H13-01685

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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