Cognitive Inhibition, Psychosocial Interactions and Suicide Attempt in Elderly (OBSUIVAL)
Primary Purpose
Suicide
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
eye tracking
neuropsychological assessement
psychiatric assessment
sociological interview
Sponsored by
About this trial
This is an interventional screening trial for Suicide focused on measuring cognitive inhibition, elderly, suicide attempt, depression
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- other psychiatric disease
- guardianship
Sites / Locations
- CHU BesanconRecruiting
- CHS Bavilliers
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
depressed with suicide attempt (SA)
depressed without a history of SA
Arm Description
elderly depressed patients with a history of suicide attempt. interventions: eye tracking, neuropsychological assessment, psychiatric assessment and sociological interview.
elderly depressed patients without a history of suicide attempt. interventions: eye tracking, neuropsychological assessment, psychiatric assessment and sociological interview.
Outcomes
Primary Outcome Measures
antisaccade error rate
Secondary Outcome Measures
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
saccadic intrusion
gaze deviation into a saccade greater than 3° during visual fixation
maximal speed of the gaze
maximum speed of visual tracking without triggering any saccade
saccade reaction time
fixation duration on pictures
social interaction quality score
Full Information
NCT ID
NCT02858427
First Posted
August 1, 2016
Last Updated
October 12, 2017
Sponsor
Centre Hospitalier Universitaire de Besancon
1. Study Identification
Unique Protocol Identification Number
NCT02858427
Brief Title
Cognitive Inhibition, Psychosocial Interactions and Suicide Attempt in Elderly
Acronym
OBSUIVAL
Official Title
Cognitive Inhibition Impairment and Suicide Attempt in Elderly: Eye Tracking Characterization and Impact of Psychosocial Interactions
Study Type
Interventional
2. Study Status
Record Verification Date
October 2017
Overall Recruitment Status
Unknown status
Study Start Date
February 6, 2017 (Actual)
Primary Completion Date
August 6, 2019 (Anticipated)
Study Completion Date
February 6, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Besancon
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Suicide
Keywords
cognitive inhibition, elderly, suicide attempt, depression
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
36 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
depressed with suicide attempt (SA)
Arm Type
Experimental
Arm Description
elderly depressed patients with a history of suicide attempt. interventions: eye tracking, neuropsychological assessment, psychiatric assessment and sociological interview.
Arm Title
depressed without a history of SA
Arm Type
Experimental
Arm Description
elderly depressed patients without a history of suicide attempt. interventions: eye tracking, neuropsychological assessment, psychiatric assessment and sociological interview.
Intervention Type
Behavioral
Intervention Name(s)
eye tracking
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
neuropsychological assessement
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
psychiatric assessment
Intervention Description
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).
Intervention Type
Behavioral
Intervention Name(s)
sociological interview
Intervention Description
this interview aims to characterize social interactions of the patients, their duration, their evolution and the perception of each participant on this subject.
Primary Outcome Measure Information:
Title
antisaccade error rate
Time Frame
1 month max. after inclusion
Secondary Outcome Measure Information:
Title
saccade accuracy
Description
distance between the eye position at the end of the first saccade, and the ideal position to engage the target in central vision
Time Frame
1 month max. after inclusion
Title
saccadic intrusion
Description
gaze deviation into a saccade greater than 3° during visual fixation
Time Frame
1 month max. after inclusion
Title
maximal speed of the gaze
Description
maximum speed of visual tracking without triggering any saccade
Time Frame
1 month max. after inclusion
Title
saccade reaction time
Time Frame
1 month max. after inclusion
Title
fixation duration on pictures
Time Frame
1 month max. after inclusion
Title
social interaction quality score
Time Frame
6 month max. after inclusion
Other Pre-specified Outcome Measures:
Title
neuropsychological test score
Time Frame
1 month max. after inclusion
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
other psychiatric disease
guardianship
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
julie monnin, PhD
Phone
0033381218543
Email
jmonnin@chu-besancon.fr
First Name & Middle Initial & Last Name or Official Title & Degree
kristina mouyabi
Phone
0033381218356
Email
kmouyabi@chu-besancon.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
pierre vandel, MD PhD
Organizational Affiliation
Centre Hospitalier Universitaire de Besancon
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Besancon
City
Besancon
State/Province
Doubs
ZIP/Postal Code
25030
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Julie Monnin, PhD
Phone
00033381218543
Email
jmonnin@chu-besancon.fr
Facility Name
CHS Bavilliers
City
Bavilliers
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Julie MONNIN, PhD
Email
jmonnin@chu-besancon.fr
First Name & Middle Initial & Last Name & Degree
Caroline MASSE-SIBILLE, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Cognitive Inhibition, Psychosocial Interactions and Suicide Attempt in Elderly
We'll reach out to this number within 24 hrs