- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03327129
Identifying the Neural Basis of Capability for Suicide
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Locations
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Ontario
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Toronto, Ontario, Canada, M5B 0C1
- St. Michael's Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion criteria for patients:
- Age between 18-70
- Capability of giving informed consent
- Not currently pregnant or lactating (due to potential confounding of brain activity as a result of differing hormone levels)
Exclusion criteria for patients:
- Lifetime history of any substance abuse, psychosis
- Current use of any opioid acting drugs
- Current use of any prescription pain medication
- Use of over the counter pain medications within 15 hours of brain scan
- For daily users of a benzodiazepine, stimulant or atypical antipsychotic, dose within 12 hours of brain scan
- For as needed users of a benzodiazepine, stimulant or atypical antipsychotic, dose within 2 weeks of brain scan. This is because non-daily use will have more unpredictable effects on brain imaging results than those who are using these medications on a regular basis. The 2 weeks will ensure the drug is not in the system.
- Medical condition requiring immediate investigation or treatment
- Participation in experimental treatment trials for the study duration.
Healthy control inclusion criteria: Ages between 18 and 70 years, capable of giving informed consent, not pregnant or lactating, no lifetime history of Axis I/II disorders, no history of antidepressant or mood stabilizer use, no treatment for acute or ongoing medical condition, no use of any over the counter pain medication for at least 15 hours prior to the brain scan.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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Healthy Controls
Subjects will have no personal or family psychiatric history and no suicide attempts.
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An fMRI scan will be conducted to collect neuroimaging data.
The scanning session will consist of a structural MRI, followed by resting state and task-based functional MRI protocol.
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Patients with SI
Subjects will have suicidal ideation (Hamilton Depression Rating Scale suicide item >=2).
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An fMRI scan will be conducted to collect neuroimaging data.
The scanning session will consist of a structural MRI, followed by resting state and task-based functional MRI protocol.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Neural network underlying acquired capability for suicide
Time Frame: 2 weeks
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Measure the correlation between acquired capability for suicide and brain activity during a pressure pain task using fMRI in patients
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2 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Correlation between pain task performance and acquired capability for suicide
Time Frame: 2 weeks
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Assess the association between pain task ratings and acquired capability for suicide in patients
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2 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Sakina Rizvi, PhD, Unity Health Toronto
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SRO-01
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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