Understanding how suicidality affects social cognition in depression

Effect of Suicidality in Major Depressive Disorder During Social Cognition

This study is trying to understand how feelings of wanting to harm oneself affect thinking and social interactions in people aged 18 to 65 with major depression, to help find better ways to prevent suicide.

Quick facts

• Study type: Observational
• Enrollment: 150 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Unity Health Toronto (Academic / other)
• Locations: 1 site (Toronto, Ontario)
• Trial ID: NCT06163612 on ClinicalTrials.gov

What this trial studies

This observational study aims to gather detailed information about individuals aged 18 to 65 who are experiencing Major Depressive Disorder (MDD). Participants will undergo clinical interviews, complete questionnaires, and have brain scans to explore the relationship between their psychiatric history, depression symptoms, and suicide attempt history. The study seeks to identify predictors of suicide attempts by analyzing various factors, including personal history and brain function. By understanding these connections, the research hopes to inform better prevention strategies for suicidal behavior in depressed individuals.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 65 who meet the criteria for Major Depressive Disorder and have moderate to severe depression.

Not a fit: Patients who do not have Major Depressive Disorder or those with mild depression may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved understanding and prevention of suicide attempts in patients with Major Depressive Disorder.

How similar studies have performed: While there have been studies examining aspects of depression and suicidality, this specific approach focusing on social cognition in relation to suicide attempts is relatively novel.

Eligibility criteria

3.2 Inclusion Criteria

Depressed Participants:

1. Between the ages of 18 and 65 years old.
2. Capable of giving voluntary and informed consent.
3. Fluent in English.
4. Meet DSM-5 criteria for single or recurrent Major Depressive Disorder (current major depressive episode), confirmed via the Mini-International Neuropsychiatric Interview (MINI 6.086).
5. Moderate to severe depression severity, defined as a 17-item Hamilton Depression Rating Scale87 score ≥ 17.
6. Have had no initiation or dose change in any psychotropic medication in the four weeks prior to screening, as confirmed by the Antidepressant Treatment History Form (ATHF88).
7. If participating in psychotherapy, must have been in stable treatment for at least 3 months prior to entry into the study, with no anticipation of change in the frequency of therapeutic sessions, or the therapeutic focus over the duration of the study.
8. Can adhere to the study schedule.
9. Either a history of or no lifetime history of suicide attempt, confirmed via the Mini-International Neuropsychiatric Interview (MINI 6.086).

Nondepressed Participants:

1. Between the ages of 18 and 65 years old.
2. Capable of giving voluntary and informed consent.
3. Fluent in English.
4. No current or lifetime history of psychiatric diagnoses or suicidality, confirmed via the MINI 6.086.
5. Absent/non-clinical depression severity, defined as a 17-item Hamilton Depression Rating Scale87 \< 8.
6. No history of antidepressant use, as measured by the ATHF88.

3.3 Exclusion Criteria

All Participants:

1. Are pregnant/lactating.
2. A MINI-confirmed diagnosis of major depressive disorder in people with bipolar disorder.
3. Other major medical comorbidities requiring immediate investigation or treatment, cardiac pacemaker, or implanted medication pump.
4. Lifetime history of psychosis, confirmed by the MINI 6.086, including schizophrenia, schizoaffective disorder, delusional disorder, or current psychotic symptoms.
5. Drug abuse or dependence within the last 6 months, excluding caffeine and nicotine.
6. Presence of contraindications for MRI, including metallic implants.
7. Have any significant neurological disorder or insult including, but not limited to: any condition likely to be associated with increased intracranial pressure, space occupying brain lesion, any history of seizure except those therapeutically induced by ECT, cerebral aneurysm, Parkinson's disease, Huntington's chorea, multiple sclerosis, dementia, significant head trauma with loss of consciousness for greater than or equal to 5 minutes.

Where this trial is running

Toronto, Ontario

• Unity Health Toronto — Toronto, Ontario, Canada (Recruiting)

Study contacts

• Principal investigator: Katharine Dunlop, PhD — Unity Health Toronto
• Study coordinator: Katharine Dunlop, PhD

Conditions Suicide; Major Depressive Disorder