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CompletedNCT02811198Updated Feb 27, 2026

Pain, Reward, Attention and Neurocircuitry: Biomarkers of Suicidality

An observational study in Major Depressive Disorder, Suicide and Suicidal Ideation, sponsored by Unity Health Toronto. Completed at 1 site in Canada. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-02-27.

Sponsored by Unity Health Toronto · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
97
Ages
18 Years to 70 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Major Depressive Disorder
  • Suicide
  • Suicidal Ideation
03

In context

Depressive Disorder, Major

2,741 studies on the registry are indexed under Depressive Disorder, Major; 559 are open to participants now.

This study's enrollment of 97 is below the median of 140 across 357 observational studies indexed under Depressive Disorder, Major.

Browse Depressive Disorder, Major studies →

Lead sponsor

Unity Health Toronto is the lead sponsor of 434 studies on the registry; 76 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 1 (20%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

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.

Inclusion criteria

  1. DSM-5 criteria for Major Depressive Episode within a MDD, confirmed through MINI diagnosis104
  2. Ages between 18 and 70 years
  3. Hamilton Depression Rating Scale - 17 item (HAMD-17) >= 14
  4. Capable of giving informed consent
  5. Groups 1 and 2 participants only: HAMD-17 item 3 (suicide) >= 2
  6. Group 2 participants only: positive history of a suicide attempt within the last six months
  7. Group 3 participants only: positive history of a lifetime suicide attempt

Exclusion criteria

Exclusion Criteria:

  1. Pregnancy/lactation
  2. Medical condition requiring immediate investigation or treatment
  3. Recent (\< 6 months)/current history of drug abuse/dependence (other than caffeine, or nicotine)
  4. Lifetime history of psychosis, Bipolar I or Bipolar II; other Axis I comorbidities are allowable
  5. 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.
  6. Participation in experimental treatment trials for the study duration.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
97 participants (actual)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • MDD with SI and No Attempt

    Subjects will have MDD with current MDE, current suicidal ideation and no lifetime suicide attempts

    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

    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.

    Other: No intervention

  • Healthy Controls

    Subjects will have no personal or family psychiatric history and no suicide attempts.

    Other: No intervention

Interventions

  • OtherNo intervention
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What researchers measure

Primary outcomes

  1. Biomarkers for Suicide Risk

    Potential biomarkers for suicide risk including brain scans, genomic or proteomic makers,

    Time frame: 12 months

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Study locations

1 site
  • Sakina Rizvi
    Toronto, Ontario M5B1M8, Canada
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 27, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02811198
Lead sponsor
Unity Health Toronto
Responsible party
Sponsor
First posted
Jun 23, 2016
Start date
Jan 1, 2017
Primary completion
Dec 9, 2024
Completion
Jan 30, 2025
Last update
Feb 27, 2026

Study contacts

Sakina Rizvi, PhD
principal investigator · Unity Health Toronto
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.

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