Major Depressive DisorderNCT02811198
Pain, Reward, Attention and Neurocircuitry: Biomarkers of Suicidality
An observational study of Major Depressive Disorder and Suicide, run by Unity Health Toronto at 1 site in Canada.
Trial summary
The ultimate aim of this study is to identify a biomarker of suicide risk in MDD by measuring the "hedonic spectrum" (pain and reward responsivity), attention and its associated brain structures using brain scans (fMRI and DTI), as well as the stability of markers over time. 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
- How many people
- 97 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jan 2017to 30 Jan 2025
- 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, University Health Networks (UHN) hospitals, and self-referrals from advertisements in Mental Health Department, and on social media.
Who may be able to join
- DSM-5 criteria for Major Depressive Episode within a MDD, confirmed through MINI diagnosis104
- Ages between 18 and 70 years
- Hamilton Depression Rating Scale - 17 item (HAMD-17) >= 14
- Capable of giving informed consent
- Groups 1 and 2 participants only: HAMD-17 item 3 (suicide) >= 2
- Group 2 participants only: positive history of a suicide attempt within the last six months
- Group 3 participants only: positive history of a lifetime suicide attempt
Who cannot join
- Pregnancy/lactation
- Medical condition requiring immediate investigation or treatment
- Recent (< 6 months)/current history of drug abuse/dependence (other than caffeine, or nicotine)
- Lifetime history of psychosis, Bipolar I or Bipolar II; other Axis I comorbidities are allowable
- Individuals who are taking a daily sedative hypnotic, atypical antipsychotic or stimulant must be on a stable dose for at least 4 weeks prior to the neuroimaging scan. The dose must not be taken after 10:00pm the evening prior to the scan. Those receiving a benzodiazepine or an atypical antipsychotic on an "as needed" basis (taken, but not every day) will be washed out of their benzodiazepine/atypical antipsychotic for two weeks prior to neuroimaging. Those receive stimulants on an "as needed" basis will be washed out for 1-3 days prior to neuroimaging, depending on the stimulant half-life.
- Participation in experimental treatment trials for the study duration.
Trial locations and contacts
1 site in 1 country.
About this study
The ultimate aim of this study is to identify a biomarker of suicide risk in MDD by measuring the "hedonic spectrum" (pain and reward responsivity), attention and its associated brain structures using brain scans (fMRI and DTI), as well as the stability of markers over time.
Read the detailed description
The issue of suicide has continued to puzzle researchers in the field of psychiatry. Edwin Shneidman, a prominent researcher on suicide emphasized "the most evident fact about suicidology and suicidal events is that they are multidimensional…containing concomitant biological, sociological, and psychological (interpersonal and intrapsychic)…elements". Yet, no study to date has attempted to integrate these dimensions when evaluating suicide risk. Considering the presence of a psychiatric illness is a primary predictor of suicide, it is important to develop a unified understanding of risk factors that integrate current clinical and neurobiological findings in this population.
Our aim is to: (1) identify an integrated biomarker model to predict risk of suicide attempt in patients with Major Depressive Disorder (MDD) with and without a history of suicide attempt, using neuroimaging, neurocognitive testing and behavioural tasks, and (2) test the stability of this model using a prospective 1 year design.
- Conditions
- Major Depressive Disorder, Suicide, Suicidal Ideation
- Being tested
- No intervention
- Medical subject headings
- Depressive Disorder, Major, Suicide, Suicidal Ideation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
| Study group | Role | What they receive |
|---|---|---|
| MDD with SI and No Attempt | Subjects will have MDD with current MDE, current suicidal ideation and no lifetime suicide attempts Receives: Other: No intervention | |
| MDD with SI and Recent Attempt | Subjects with have MDD with current MDE, current suicidal ideation and a suicide attempt within the past 6 months Receives: Other: No intervention | |
| MDD with no SI and Lifetime Attempt | Subjects with MDD and current MDE but no current suicidal ideation and a lifetime suicide attempt. Receives: Other: No intervention | |
| Healthy Controls | Subjects will have no personal or family psychiatric history and no suicide attempts. Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biomarkers for Suicide Risk
Potential biomarkers for suicide risk including brain scans, genomic or proteomic makers,
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2016 (estimated)
- Study start1 Jan 2017
- Primary completion9 Dec 2024
- Study completion30 Jan 2025
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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 97 participants (actual)
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
- NCT02811198
- Sponsor's protocol ID
- SBIO-01
- Status last verified
- Feb 2026
- First submitted
- 20 Jun 2016
- Last updated
- 27 Feb 2026
- Results posted
- 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
- Pain, Reward, Attention and Neurocircuitry: Biomarkers of Suicidality
- ClinicalTrials.gov ID
- NCT02811198
- Acronym / sponsor ID
- SBIO-01
- Conditions
- Major Depressive Disorder, Suicide, Suicidal Ideation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- Unity Health TorontoUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 9 Dec 2024 (actual)
- Study completion
- 30 Jan 2025 (actual)
- First posted
- 23 Jun 2016 (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 ultimate aim of this study is to identify a biomarker of suicide risk in MDD by measuring the "hedonic spectrum" (pain and reward responsivity), attention and its associated brain structures using brain scans (fMRI and DTI), as well as the stability of markers over time.
Detailed description
The issue of suicide has continued to puzzle researchers in the field of psychiatry. Edwin Shneidman, a prominent researcher on suicide emphasized "the most evident fact about suicidology and suicidal events is that they are multidimensional…containing concomitant biological, sociological, and psychological (interpersonal and intrapsychic)…elements". Yet, no study to date has attempted to integrate these dimensions when evaluating suicide risk. Considering the presence of a psychiatric illness is a primary predictor of suicide, it is important to develop a unified understanding of risk factors that integrate current clinical and neurobiological findings in this population.
Our aim is to: (1) identify an integrated biomarker model to predict risk of suicide attempt in patients with Major Depressive Disorder (MDD) with and without a history of suicide attempt, using neuroimaging, neurocognitive testing and behavioural tasks, and (2) test the stability of this model using a prospective 1 year design.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| MDD with SI and No Attempt | – | Other: No interventionSubjects will have MDD with current MDE, current suicidal ideation and no lifetime suicide attempts |
| MDD with SI and Recent Attempt | – | Other: No interventionSubjects with have MDD with current MDE, current suicidal ideation and a suicide attempt within the past 6 months |
| MDD with no SI and Lifetime Attempt | – | Other: No interventionSubjects with MDD and current MDE but no current suicidal ideation and a lifetime suicide attempt. |
| Healthy Controls | – | Other: No interventionSubjects will have no personal or family psychiatric history and no suicide attempts. |
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, University Health Networks (UHN) hospitals, and self-referrals from advertisements in Mental Health Department, and on social media.
Key inclusion criteria (7 listed)
- DSM-5 criteria for Major Depressive Episode within a MDD, confirmed through MINI diagnosis104
- Ages between 18 and 70 years
- Hamilton Depression Rating Scale - 17 item (HAMD-17) >= 14
- Capable of giving informed consent
- Groups 1 and 2 participants only: HAMD-17 item 3 (suicide) >= 2
Key exclusion criteria (6 listed)
- Pregnancy/lactation
- Medical condition requiring immediate investigation or treatment
- Recent (< 6 months)/current history of drug abuse/dependence (other than caffeine, or nicotine)
- Lifetime history of psychosis, Bipolar I or Bipolar II; other Axis I comorbidities are allowable
- Individuals who are taking a daily sedative hypnotic, atypical antipsychotic or stimulant must be on a stable dose for at least 4 weeks prior to the neuroimaging scan. The dose must not be taken after 10:00pm the evening prior to the scan. Those receiving a benzodiazepine or an atypical antipsychotic on an "as needed" basis (taken, but not every day) will be washed out of their benzodiazepine/atypical antipsychotic for two weeks prior to neuroimaging. Those receive stimulants on an "as needed" basis will be washed out for 1-3 days prior to neuroimaging, depending on the stimulant half-life.
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 |
|---|---|---|
| No intervention | Other | Healthy Controls, MDD with SI and No Attempt, MDD with SI and Recent Attempt, MDD with no SI and Lifetime Attempt |
Primary outcome
Biomarkers for Suicide Risk
Time frame: 12 months
Potential biomarkers for suicide risk including brain scans, genomic or proteomic makers,
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
Related trials for Major Depressive Disorder
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
RecruitingPhase 4
Biomarker-Guided Antidepressant Selection
Depression - Major Depressive Disorder, Treatment-resistant Depression (TRD)
Recruiting
Targeting Network Dysfunction in Apathy of Late-life Depression Using Digital Therapeutics
Major Depressive Disorder, Apathy
RecruitingObservational study
Student Precarity and Psychiatry
Depressive Disorder, Major, Generalized Anxiety Disorder
Not yet recruiting
Acute Intermittent Hypoxia Therapy for Depression
Major Depressive Disorder (MDD)
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 7 inclusion and 6 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: finished, 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Biomarkers for Suicide Risk (time frame: 12 months). 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.