Identifying the Neural Basis of Capability for Suicide

Major Depressive Disorder Clinical Trial

Official title:

Identifying the Neural Basis of Capability for Suicide

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03327129
• Other study ID #: SRO-01
• Status: Recruiting
• Start date: January 1, 2023
• Est. completion date: September 2024

Study information

• Verified date: April 2023
• Source: Unity Health Toronto
• Contact: Hailey Wright, B.Arts. Sc
• Phone: 4168646060
• Email: Hailey.Wright[@]unityhealth.to
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Since capability for suicide involves overriding potential pain, and the opioid system plays a strong role in controlling pain perception, it follows that capability for suicide may be impacted by the opioid system. The goal of the proposed research is to identify the neural network underlying capability for suicide in order to determine if it can be a target for identifying high-risk individuals and for intervention.

Description:

Little evidence exists distinguishing individuals with suicidal ideation (SI) from those at risk for suicidal behaviour, illustrating the need for more comprehensive biomarkers for clinicians to guide their treatment approach and for new treatment avenues. Current theories of suicide have suggested the importance of an individual's capability for suicide in predicting suicide attempt or death. Building on this, Yovell and colleagues (2016) provided important preliminary data that the opioid system affects suicide risk, but the neural mechanisms and their relationship to capability for suicide are unclear. The goal of the proposed research is to identify the neural network underlying capability for suicide using functional magnetic resonance imaging (fMRI) in order to determine if it can be a target for identifying high-risk individuals and for intervention.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: September 2024
• Est. primary completion date: September 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder
• Mental Disorders
• Psychiatric Illness
• Suicidal Ideation
• Suicide

Intervention

Procedure:
• fMRI
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.

Locations

Country	Name	City	State
Canada	St. Michael's Hospital	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Unity Health Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Neural network underlying acquired capability for suicide	Measure the correlation between acquired capability for suicide and brain activity during a pressure pain task using fMRI in patients	2 weeks
Secondary	Correlation between pain task performance and acquired capability for suicide	Assess the association between pain task ratings and acquired capability for suicide in patients	2 weeks