Pain, Reward, Attention and Neurocircuitry: Biomarkers of Suicidality

Unity Health Toronto

Status: Enrolling

Conditions: Major Depressive Disorder; Suicidal Ideation; Suicide

Treatments: Other: No intervention

Study type: Observational

Funder types: Other

Identifiers

NCT02811198

SBIO-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

120 participants in 4 patient groups

MDD with SI and No Attempt

Description:

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

Treatment:

Other: No intervention

MDD with SI and Recent Attempt

Description:

Subjects with have MDD with current MDE, current suicidal ideation and a suicide attempt within the past 6 months

Treatment:

Other: No intervention

MDD with no SI and Lifetime Attempt

Description:

Subjects with MDD and current MDE but no current suicidal ideation and a lifetime suicide attempt.

Treatment:

Other: No intervention

Healthy Controls

Description:

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

Treatment:

Other: No intervention