SuicideOBSUIVALNCT02858427
Cognitive Inhibition, Psychosocial Interactions and Suicide Attempt in Elderly
A study testing eye tracking, neuropsychological assessement and psychiatric assessment in people with Suicide, run by Centre Hospitalier Universitaire de Besancon at 2 sites in France.
Trial summary
The study aims to determine the correlation between the cognitive inhibition impairment and the history of suicide attempt in elderly depressed patients. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Suicide
- What is being tested?
- eye tracking, neuropsychological assessement and psychiatric assessment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 2 sitesFrance
- Study dates
- 6 Feb 2017to 6 Feb 2020
- Phase
- Interventional
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- major depressive disorder according to Diagnostic ans Statistical Manual (DSM) V
- group 1: with a history of suicide attempt
- group 2: without a history of suicide attempt
Who cannot join
- other psychiatric disease
- guardianship
Trial locations and contacts
2 sites in 1 country.
France2 sites, 2 recruiting
- Not yet recruiting
CHS Bavilliers
Bavilliers
Julie MONNIN, PhD, jmonnin@chu-besancon.fr
Caroline MASSE-SIBILLE, MD
- Recruiting
CHU Besancon
Besançon, Doubs, 25030
Julie Monnin, PhD, 00033381218543, jmonnin@chu-besancon.fr
About this study
Official title: Cognitive Inhibition Impairment and Suicide Attempt in Elderly: Eye Tracking Characterization and Impact of Psychosocial Interactions
The study aims to determine the correlation between the cognitive inhibition impairment and the history of suicide attempt in elderly depressed patients.
Read the detailed description
2 groups of patients will be studied: in the first group, depressed patients with a history of suicide attempt will be included whereas in the second group, depressed patients without a history of suicide attempt will be included.
For each group, the cognitive inhibition will be assessed trough an eye tracker task (antisaccade).
Both groups will also be compared on their neuropsychological characteristics and the quality of social interactions of participants.
- Conditions
- Suicide
- Being tested
- eye tracking, neuropsychological assessement, psychiatric assessment, sociological interview
- Keywords
- cognitive inhibition, elderly, suicide attempt, depression
- Medical subject headings
- Suicide, Suicide, Attempted, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
eye trackingBehavioural
several oculomotor parameters will be recorded using vide-oculography techniques (eye tracking) trough different tasks: saccade, antisaccade, and picture scanning.
Saccade task: the patient is looking at a screen and is asked to fix his gaze as quickly and accurately as possible on the red dot appearing on the periphery of the screen.
Prosaccade task: the patient is looking at a screen and is asked to fix his gaze as quickly and accurately as possible on the opposite side relative to the red dot appearing on the periphery of the screen.
Picture Scanning: participant is instructed to freely watch pictures with different emotional valence.
neuropsychological assessementBehavioural
the neuropsychological assessment aims to identify any impairment of executive functioning through several tasks: Mini mental state examination (mmse), isaac set test (STI) trail making test (TMT A and B), Grober test, Stroop test, verbal fluency, Go No Go task, memory impairment screen (MIS), picture naming test (DO30), copying figure test, digit span and categorical matching test.
psychiatric assessmentBehavioural
this evaluation aims to characterize the mental status of the patient. Different scales will be used: Montgomery and ASberg depression rating scale (MADRS), Columbia-suicide severity rating scale (C-SSRS), Beck depression inventory (BDI), Barratt impulsiveness scale (BIS-10), Buss and Durkee Hostility Inventory (BDHI), Balloon, analogue risk task (BART), Iowa gambling task (IGT), and Childhood trauma questionnaire (CTQ).
sociological interviewBehavioural
this interview aims to characterize social interactions of the patients, their duration, their evolution and the perception of each participant on this subject.
| Study group | Role | What they receive |
|---|---|---|
| depressed with suicide attempt (SA) | Experimental | elderly depressed patients with a history of suicide attempt. interventions: eye tracking, neuropsychological assessment, psychiatric assessment and sociological interview. Receives: Behavioral: eye tracking; Behavioral: neuropsychological assessement; Behavioral: psychiatric assessment; Behavioral: sociological interview |
| depressed without a history of SA | Experimental | elderly depressed patients without a history of suicide attempt. interventions: eye tracking, neuropsychological assessment, psychiatric assessment and sociological interview. Receives: Behavioral: eye tracking; Behavioral: neuropsychological assessement; Behavioral: psychiatric assessment; Behavioral: sociological interview |
What is being measured
The primary outcome is the main question the study is designed to answer.
antisaccade error rate
Measured: 1 month max. after inclusion
Secondary outcomes (6)
saccade accuracy
distance between the eye position at the end of the first saccade, and the ideal position to engage the target in central vision
Measured: 1 month max. after inclusion
saccadic intrusion
gaze deviation into a saccade greater than 3° during visual fixation
Measured: 1 month max. after inclusion
maximal speed of the gaze
maximum speed of visual tracking without triggering any saccade
Measured: 1 month max. after inclusion
saccade reaction time
Measured: 1 month max. after inclusion
fixation duration on pictures
Measured: 1 month max. after inclusion
social interaction quality score
Measured: 6 month max. after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2016 (estimated)
- Study start6 Feb 2017
- Primary completion6 Aug 2019 (estimated)
- Study completion6 Feb 2020 (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 Centre Hospitalier Universitaire de BesanconThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- pierre vandel, MD PhD, Principal investigator, Centre Hospitalier Universitaire de Besancon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02858427
- Sponsor's protocol ID
- P/2016/288
- Acronym
- OBSUIVAL
- Status last verified
- Oct 2017
- First submitted
- 1 Aug 2016
- Last updated
- 13 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Inhibition Impairment and Suicide Attempt in Elderly: Eye Tracking Characterization and Impact of Psychosocial Interactions
- ClinicalTrials.gov ID
- NCT02858427
- Acronym / sponsor ID
- OBSUIVAL / P/2016/288
- Conditions
- Suicide
- Keywords
- cognitive inhibition, elderly, suicide attempt, depression
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- Study start
- 6 Feb 2017 (actual)
- Primary completion
- 6 Aug 2019 (estimated)
- Study completion
- 6 Feb 2020 (estimated)
- First posted
- 8 Aug 2016 (estimated)
- 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.
The study aims to determine the correlation between the cognitive inhibition impairment and the history of suicide attempt in elderly depressed patients.
Detailed description
2 groups of patients will be studied: in the first group, depressed patients with a history of suicide attempt will be included whereas in the second group, depressed patients without a history of suicide attempt will be included.
For each group, the cognitive inhibition will be assessed trough an eye tracker task (antisaccade).
Both groups will also be compared on their neuropsychological characteristics and the quality of social interactions of participants.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| depressed with suicide attempt (SA) | Experimental | Behavioral: eye tracking, Behavioral: neuropsychological assessement, Behavioral: psychiatric assessment, Behavioral: sociological interviewelderly depressed patients with a history of suicide attempt. interventions: eye tracking, neuropsychological assessment, psychiatric assessment and sociological interview. |
| depressed without a history of SA | Experimental | Behavioral: eye tracking, Behavioral: neuropsychological assessement, Behavioral: psychiatric assessment, Behavioral: sociological interviewelderly depressed patients without a history of suicide attempt. interventions: eye tracking, neuropsychological assessment, psychiatric assessment and sociological interview. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- major depressive disorder according to Diagnostic ans Statistical Manual (DSM) V
- group 1: with a history of suicide attempt
- group 2: without a history of suicide attempt
Key exclusion criteria (2 listed)
- other psychiatric disease
- guardianship
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 |
|---|---|---|
| eye trackingseveral oculomotor parameters will be recorded using vide-oculography techniques (eye tracking) trough different tasks: saccade, antisaccade, and picture scanning. Saccade task: the patient is looking at a screen and is asked to fix his gaze as quickly and accurately as possible on the red dot appearing on the periphery of the screen. Prosaccade task: the patient is looking at a screen and is asked to fix his gaze as quickly and accurately as possible on the opposite side relative to the red dot appearing on the periphery of the screen. Picture Scanning: participant is instructed to freely watch pictures with different emotional valence. | Behavioural | depressed with suicide attempt (SA), depressed without a history of SA |
| neuropsychological assessementthe neuropsychological assessment aims to identify any impairment of executive functioning through several tasks: Mini mental state examination (mmse), isaac set test (STI) trail making test (TMT A and B), Grober test, Stroop test, verbal fluency, Go No Go task, memory impairment screen (MIS), picture naming test (DO30), copying figure test, digit span and categorical matching test. | Behavioural | depressed with suicide attempt (SA), depressed without a history of SA |
| psychiatric assessmentthis evaluation aims to characterize the mental status of the patient. Different scales will be used: Montgomery and ASberg depression rating scale (MADRS), Columbia-suicide severity rating scale (C-SSRS), Beck depression inventory (BDI), Barratt impulsiveness scale (BIS-10), Buss and Durkee Hostility Inventory (BDHI), Balloon, analogue risk task (BART), Iowa gambling task (IGT), and Childhood trauma questionnaire (CTQ). | Behavioural | depressed with suicide attempt (SA), depressed without a history of SA |
| sociological interviewthis interview aims to characterize social interactions of the patients, their duration, their evolution and the perception of each participant on this subject. | Behavioural | depressed with suicide attempt (SA), depressed without a history of SA |
Primary outcome
antisaccade error rate
Time frame: 1 month max. after inclusion
6 secondary outcomes
saccade accuracy
Time frame: 1 month max. after inclusion
saccadic intrusion
Time frame: 1 month max. after inclusion
maximal speed of the gaze
Time frame: 1 month max. after inclusion
saccade reaction time
Time frame: 1 month max. after inclusion
fixation duration on pictures
Time frame: 1 month max. after inclusion
social interaction quality score
Time frame: 6 month max. after inclusion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2017.
- Individual participant dataSharing planned: No
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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.
pierre vandel, MD PhD principal investigator
Centre Hospitalier Universitaire de Besancon
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing eye tracking, neuropsychological assessement and psychiatric assessment in people with Suicide, run by Centre Hospitalier Universitaire de Besancon at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. 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 13 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. 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 julie monnin, PhD (0033381218543, jmonnin@chu-besancon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
antisaccade error rate (time frame: 1 month max. after inclusion). 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 13 Oct 2017.