Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
150 participants
OBSERVATIONAL
2022-09-01
2024-12-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
CROSS_SECTIONAL
Study Groups
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Healthy controls, or people who do not have depression.
Clinical Interview
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.
Clinical 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.
Brain Scan
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.
Behavioural 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.
People diagnosed with MDD and a history of suicide attempt
Clinical Interview
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.
Clinical 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.
Brain Scan
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.
Behavioural 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.
People diagnosed with MDD without a history of suicide attempt
Clinical Interview
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.
Clinical 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.
Brain Scan
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.
Behavioural 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.
Interventions
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Clinical Interview
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.
Clinical 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.
Brain Scan
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.
Behavioural 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.
Eligibility Criteria
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Inclusion Criteria
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.
Exclusion Criteria
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.
18 Years
65 Years
ALL
No
Sponsors
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Unity Health Toronto
OTHER
Responsible Party
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Principal Investigators
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Katharine Dunlop, PhD
Role: PRINCIPAL_INVESTIGATOR
Unity Health Toronto
Locations
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Unity Health Toronto
Toronto, Ontario, Canada
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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21-333
Identifier Type: -
Identifier Source: org_study_id
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