Pain, Reward, Attention and Neurocircuitry: Biomarkers of Suicidality

February 24, 2026 updated by: Unity Health Toronto
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.

Study Overview

Status

Completed

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

97

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Ontario
      • Toronto, Ontario, Canada, M5B1M8
        • Sakina Rizvi

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

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.

Description

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:

  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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
MDD with SI and No Attempt
Subjects will have MDD with current MDE, current suicidal ideation and no lifetime suicide attempts
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
MDD with no SI and Lifetime Attempt
Subjects with MDD and current MDE but no current suicidal ideation and a lifetime suicide attempt.
Healthy Controls
Subjects will have no personal or family psychiatric history and no suicide attempts.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Biomarkers for Suicide Risk
Time Frame: 12 months
Potential biomarkers for suicide risk including brain scans, genomic or proteomic makers,
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Sakina Rizvi, PhD, Unity Health Toronto

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2017

Primary Completion (Actual)

December 9, 2024

Study Completion (Actual)

January 30, 2025

Study Registration Dates

First Submitted

June 20, 2016

First Submitted That Met QC Criteria

June 20, 2016

First Posted (Estimated)

June 23, 2016

Study Record Updates

Last Update Posted (Actual)

February 27, 2026

Last Update Submitted That Met QC Criteria

February 24, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

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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