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OpenTrials
Completed

NCT Number: NCT02811198

Pain, Reward, Attention and Neurocircuitry: Biomarkers of Suicidality

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Sakina Rizvi

Toronto, Ontario, M5B1M8, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

No intervention

Other

Primary outcomes

  1. Biomarkers for Suicide Risk

    Time frame: 12 months

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

Sponsors and collaborators

Lead sponsor

Unity Health Toronto

Other

Registry information

Important dates

Study start
2017
Primary completion
2024
Study completion
2025
First posted
Jun 23, 2016
Registry last updated
Feb 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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