SuicideNCT06163612
Effect of Suicidality on Social Cognition
An observational study of Suicide and Major Depressive Disorder, run by Unity Health Toronto at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Suicide, Major Depressive Disorder
- What is being tested?
- Clinical Interview, Clinical Questionnaires and Brain Scan
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 150 participants
- Where
- 1 siteCanada
- Study dates
- 1 Sep 2022to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Adult, Older adult
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.
3.2 Inclusion Criteria
Depressed Participants:
- Between the ages of 18 and 65 years old.
- Capable of giving voluntary and informed consent.
- Fluent in English.
- 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).
- Moderate to severe depression severity, defined as a 17-item Hamilton Depression Rating Scale87 score ≥ 17.
- 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).
- 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.
- Can adhere to the study schedule.
- Either a history of or no lifetime history of suicide attempt, confirmed via the Mini-International Neuropsychiatric Interview (MINI 6.086).
Nondepressed Participants:
- Between the ages of 18 and 65 years old.
- Capable of giving voluntary and informed consent.
- Fluent in English.
- No current or lifetime history of psychiatric diagnoses or suicidality, confirmed via the MINI 6.086.
- Absent/non-clinical depression severity, defined as a 17-item Hamilton Depression Rating Scale87 < 8.
- No history of antidepressant use, as measured by the ATHF88.
3.3 Exclusion Criteria
All Participants:
- Are pregnant/lactating.
- A MINI-confirmed diagnosis of major depressive disorder in people with bipolar disorder.
- Other major medical comorbidities requiring immediate investigation or treatment, cardiac pacemaker, or implanted medication pump.
- Lifetime history of psychosis, confirmed by the MINI 6.086, including schizophrenia, schizoaffective disorder, delusional disorder, or current psychotic symptoms.
- Drug abuse or dependence within the last 6 months, excluding caffeine and nicotine.
- Presence of contraindications for MRI, including metallic implants.
- 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.
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Unity Health Toronto
Toronto, Ontario, M5B1M8
Katharine Dunlop, PhD, 416-864-6060 ext. 4078, katharine.dunlop@unityhealth.to
About this study
Official title: Effect of Suicidality in Major Depressive Disorder During Social Cognition
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.
- Conditions
- Suicide, Major Depressive Disorder
- Being tested
- Clinical Interview, Clinical Questionnaires, Brain Scan, Behavioural Games
- Medical subject headings
- Suicide, Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical InterviewBehavioural
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 QuestionnairesBehavioural
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 ScanOther
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 GamesBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Healthy controls, or people who do not have depression. | Not described Receives: Behavioral: Clinical Interview; Behavioral: Clinical Questionnaires; Other: Brain Scan; Behavioral: Behavioural Games | |
| People diagnosed with MDD and a history of suicide attempt | Not described Receives: Behavioral: Clinical Interview; Behavioral: Clinical Questionnaires; Other: Brain Scan; Behavioral: Behavioural Games | |
| People diagnosed with MDD without a history of suicide attempt | Not described Receives: Behavioral: Clinical Interview; Behavioral: Clinical Questionnaires; Other: Brain Scan; Behavioral: Behavioural Games |
What is being measured
The primary outcome is the main question the study is designed to answer.
fMRI Markers for Suicide Risk
Potential fMRI brain activity for suicide risk using participants' brain scans
Measured: Through study completion, an average of 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2023
- Study start1 Sep 2022
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SuicideStudies of the same condition, open and under way.
- More trials run by Unity Health TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Unity Health Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Katharine Dunlop, PhD, Principal investigator, Unity Health Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06163612
- Sponsor's protocol ID
- 21-333
- Status last verified
- May 2024
- First submitted
- 22 Nov 2023
- Last updated
- 9 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Suicidality in Major Depressive Disorder During Social Cognition
- ClinicalTrials.gov ID
- NCT06163612
- Acronym / sponsor ID
- 21-333
- Conditions
- Suicide, Major Depressive Disorder
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Unity Health TorontoUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 11 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Healthy controls, or people who do not have depression. | – | Behavioral: Clinical Interview, Behavioral: Clinical Questionnaires, Other: Brain Scan, Behavioral: Behavioural Games |
| People diagnosed with MDD and a history of suicide attempt | – | Behavioral: Clinical Interview, Behavioral: Clinical Questionnaires, Other: Brain Scan, Behavioral: Behavioural Games |
| People diagnosed with MDD without a history of suicide attempt | – | Behavioral: Clinical Interview, Behavioral: Clinical Questionnaires, Other: Brain Scan, Behavioral: Behavioural Games |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clinical InterviewA 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. | Behavioural | Healthy controls, or people who do not have depression., People diagnosed with MDD and a history of suicide attempt, People diagnosed with MDD without a history of suicide attempt |
| Clinical QuestionnairesA 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. | Behavioural | Healthy controls, or people who do not have depression., People diagnosed with MDD and a history of suicide attempt, People diagnosed with MDD without a history of suicide attempt |
| Brain ScanThe 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. | Other | Healthy controls, or people who do not have depression., People diagnosed with MDD and a history of suicide attempt, People diagnosed with MDD without a history of suicide attempt |
| Behavioural GamesThe 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. | Behavioural | Healthy controls, or people who do not have depression., People diagnosed with MDD and a history of suicide attempt, People diagnosed with MDD without a history of suicide attempt |
Primary outcome
fMRI Markers for Suicide Risk
Time frame: Through study completion, an average of 1 week
Potential fMRI brain activity for suicide risk using participants' brain scans
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Katharine Dunlop, PhD principal investigator
Unity Health Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Suicide and Major Depressive Disorder, run by Unity Health Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Katharine Dunlop, PhD (416-864-6060 ext. 4078, katharine.dunlop@unityhealth.to), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
fMRI Markers for Suicide Risk (time frame: Through study completion, an average of 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2024.