Identifying biomarkers for suicide risk in major depression
Pain, Reward, Attention and Neurocircuitry: Biomarkers of Suicidality
This study is trying to find biological signs that can help predict suicide risk in people with major depression by looking at how their brains respond to pain and rewards.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 120 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Unity Health Toronto Academic / other |
| Locations | 1 site (Toronto, Ontario) |
| Trial ID | NCT02811198 on ClinicalTrials.gov |
What this trial studies
This observational study aims to identify biomarkers that predict suicide risk in individuals with Major Depressive Disorder (MDD) by measuring pain and reward responsivity, attention, and associated brain structures using advanced neuroimaging techniques like fMRI and DTI. The study will integrate biological, psychological, and sociological factors to develop a comprehensive understanding of suicide risk. Participants will undergo neurocognitive testing and behavioral tasks, with the stability of identified biomarkers assessed over a one-year period.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 to 70 with a diagnosis of Major Depressive Disorder and varying histories of suicidal ideation or attempts.
Not a fit: Patients with conditions such as pregnancy, active substance abuse, or severe psychiatric disorders like psychosis or bipolar disorder may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved methods for predicting and preventing suicide in patients with major depression.
How similar studies have performed: While there have been studies exploring aspects of suicide risk, this integrated approach combining neurobiological and psychological factors is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Toronto, Ontario
- Sakina Rizvi — Toronto, Ontario, Canada (Recruiting)
Study contacts
- Principal investigator: Sakina Rizvi, PhD — Unity Health Toronto
- Study coordinator: Hailey Wright, B.Arts. Sc
- Email: Hailey.Wright@unityhealth.to
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.