Clinical trial NCT06163612: Effect of Suicidality on Social Cognition
Official title: Effect of Suicidality in Major Depressive Disorder During Social Cognition
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Suicide
Major Depressive Disorder
Lead sponsor: Unity Health Toronto
Sponsor class: OTHER
First posted: 2023-12-11
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: People will be assessed for a major depressive episode and history of suicide attempt. There will be three samples enrolled in this study:

* Group 1: 50 healthy controls, or people who do not have depression.
* Group 2: 50 people diagnosed with MDD and a history of suicide attempt
* Group 3: 50 people diagnosed with MDD without a history of suicide attempt.

Brief summary: Major Depressive Disorder (MDD) is a very common illness that is usually treated with antidepressant medication. Depression can be caused by many things such as childhood experiences, genetics, and changes in the way the body and brain function. It is most likely caused by a combination of several of these factors. The prevalence of suicide attempt in Major Depressive Disorder (MDD) is about 20%. Risk for suicide attempt can be increased by many things such as negative life events, genetics, and changes in the way the body and brain function. It is most likely caused by a combination of several of these factors.

In this study, the investigators will be collecting detailed information about participants' psychiatric history and depression symptoms, as well as brain scans. The goal is to use this information to help us determine what predicts suicide attempt history.


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.

Primary outcomes:
measure: fMRI Markers for Suicide Risk
timeFrame: Through study completion, an average of 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Unity Health Toronto
state: Ontario
Study officials:
affiliation: Unity Health Toronto
name: Katharine Dunlop, PhD
role: PRINCIPAL_INVESTIGATOR
References: