Major Depressive DisorderNCT03327129
Identifying the Neural Basis of Capability for Suicide
An observational study of Major Depressive Disorder and Suicide, run by Unity Health Toronto at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Major Depressive Disorder, Suicide, Suicidal Ideation
- What is being tested?
- fMRI
- Type of treatment
- Surgery or procedure
- How many people
- 90 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jan 2023to Sep 2028
- 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 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Subjects will recruited from Mental Health Clinics at St. Michael's Hospital from Mood Disorders Clinics and self-referrals from advertisements in Mental Health Department.
Who may be able to join
- 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)
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed 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.
- Being tested
- fMRI
- Medical subject headings
- Depressive Disorder, Major, Suicide, Suicidal Ideation, Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fMRIProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Controls | Subjects will have no personal or family psychiatric history and no suicide attempts. Receives: Procedure: fMRI | |
| Patients with SI | Subjects will have suicidal ideation (Hamilton Depression Rating Scale suicide item >=2). Receives: Procedure: fMRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2 weeks
Secondary outcomes (1)
Correlation between pain task performance and acquired capability for suicide
Assess the association between pain task ratings and acquired capability for suicide in patients
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2017
- Study start1 Jan 2023
- Primary completion1 Apr 2025
- Study completionSep 2028 (estimated)
Why it stopped: Study is currently on pause until further funding is received to continue the project.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- More trials run by Unity Health TorontoThe 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Unity Health Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sakina Rizvi, PhD, Principal investigator, Unity Health Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03327129
- Sponsor's protocol ID
- SRO-01
- Status last verified
- Feb 2026
- First submitted
- 23 Oct 2017
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identifying the Neural Basis of Capability for Suicide
- ClinicalTrials.gov ID
- NCT03327129
- Acronym / sponsor ID
- SRO-01
- Study type
- Observational
- Recruitment status
- SuspendedReason stopped: Study is currently on pause until further funding is received to continue the project.
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Unity Health TorontoUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 1 Apr 2025 (actual)
- Study completion
- Sep 2028 (estimated)
- First posted
- 31 Oct 2017 (actual)
- 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.
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.
Detailed 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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy Controls | – | Procedure: fMRISubjects will have no personal or family psychiatric history and no suicide attempts. |
| Patients with SI | – | Procedure: fMRISubjects will have suicidal ideation (Hamilton Depression Rating Scale suicide item >=2). |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects will recruited from Mental Health Clinics at St. Michael's Hospital from Mood Disorders Clinics and self-referrals from advertisements in Mental Health Department.
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| fMRIAn 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. | Procedure or surgery | Healthy Controls, Patients with SI |
Primary outcome
Neural network underlying acquired capability for suicide
Time frame: 2 weeks
Measure the correlation between acquired capability for suicide and brain activity during a pressure pain task using fMRI in patients
1 secondary outcome
Correlation between pain task performance and acquired capability for suicide
Time frame: 2 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
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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.
Sakina Rizvi, PhD principal investigator
Unity Health Toronto
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 Major Depressive Disorder and Suicide, run by Unity Health Toronto 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 3 inclusion and 9 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: paused, as of the sponsor's last update on 27 Feb 2026. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neural network underlying acquired capability for suicide (time frame: 2 weeks). 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 27 Feb 2026.