Pain, Reward, Attention and Neurocircuitry: Biomarkers of Suicidality

NCT02811198 | Completed

• 1 other identifier: SBIO-01
• Study Type: observational
• Target: 97
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Major Depressive Disorder; Suicide; Suicidal Ideation

Outcome Measures

Primary Outcomes (1)

• Biomarkers for Suicide Risk

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

  12 months

Study Arms (4)

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

No intervention OTHER

Healthy Controls; MDD with SI and No Attempt; MDD with SI and Recent Attempt; MDD with no SI and Lifetime Attempt

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Unity Health Toronto: lead

Study Sites (1)

Sakina Rizvi

Toronto, Ontario, M5B1M8, Canada

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples will be collected for genetic and proteomic analysis. Saliva samples will be collected to measure cortisol levels.

MeSH Terms

Conditions

Depressive Disorder, Major; Suicide; Suicidal Ideation

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Self-Injurious Behavior; Behavioral Symptoms; Behavior

Study Officials

• Sakina Rizvi, PhD

  Unity Health Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2016
• First Posted: June 23, 2016
• Study Start: January 1, 2017
• Primary Completion: December 9, 2024
• Study Completion: January 30, 2025
• Last Updated: February 27, 2026

Record last verified: 2026-02

Locations

CA (1)