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Effect of Suicidality on Social Cognition

Effect of Suicidality in Major Depressive Disorder During Social Cognition

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06163612
Enrollment
150
Registered
2023-12-11
Start date
2022-09-01
Completion date
2024-12-31
Last updated
2024-05-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Suicide, Major Depressive Disorder

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.

Interventions

A study team member will meet the participant to ask questions regarding the degree of depression at the beginning of the study. This interview will take approximately 1 hour.

BEHAVIORALClinical Questionnaires

A study team member will ask the participant to complete questionnaires assessing the severity of the participant's depression, daily activities, personality/traits, and quality of life. If the participant opts to complete these questionnaires at home, they will be emailed them within 24 hours of this visit. These questionnaires will take approximately 1-2 hours.

The participant will be asked to undergo a magnetic resonance imaging (MRI) scan to look at the structure and function of their brain. The functional MRI measures the level of blood flow to areas of the brain associated with mood and behaviour, and the participant will be asked to complete two behavioural games while they are in the scanner. During the scan, the participant will be required to lie on a table within the cylindrical tube of the MRI scanner in order to complete the scan. This will result in limited movement for the duration of the scan. The scan will take approximately 60 minutes.

BEHAVIORALBehavioural Games

The participant will be asked to complete two behavioural games inside the scanner. One of these games includes a monetary payout. They will be given instructions about these tasks outside of the scanner.

Sponsors

Unity Health Toronto
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years

Inclusion 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.

Design outcomes

Primary

MeasureTime frameDescription
fMRI Markers for Suicide RiskThrough study completion, an average of 1 weekPotential fMRI brain activity for suicide risk using participants' brain scans

Countries

Canada

Contacts

Primary ContactKatharine Dunlop, PhD
katharine.dunlop@unityhealth.to416-864-6060

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026