Cognitive Inhibition, Psychosocial Interactions and Suicide Attempt in Elderly (OBSUIVAL)

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.

Study Overview

• Status: Unknown
• Conditions: Suicide
• Intervention / Treatment: Behavioral: eye tracking; Behavioral: neuropsychological assessement; Behavioral: psychiatric assessment; Behavioral: sociological interview

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 Type: Interventional
• Enrollment (Anticipated): 36
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: julie monnin, PhD; Phone Number: 0033381218543; Email: jmonnin@chu-besancon.fr
• Study Contact Backup: Name: Kristina Mouyabi; Phone Number: 0033381218356; Email: kmouyabi@chu-besancon.fr

Study Locations

• France
  • Bavilliers, France
    • Not yet recruiting
    • CHS Bavilliers
    • Contact: Julie MONNIN, PhD; Email: jmonnin@chu-besancon.fr
    • Principal Investigator: Caroline Masse-Sibille, MD
  • Doubs
    • Besancon, Doubs, France, 25030
      • Recruiting
      • CHU Besançon
      • Contact: Julie Monnin, PhD; Phone Number: 00033381218543; Email: jmonnin@chu-besancon.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Non-Randomized
• Interventional Model: Factorial Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: depressed with suicide attempt (SA); elderly depressed patients with a history of suicide attempt. interventions: eye tracking, neuropsychological assessment, psychiatric assessment and sociological interview.	Behavioral: eye tracking; 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.; Behavioral: neuropsychological assessement; 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.; Behavioral: psychiatric assessment; 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).; Behavioral: sociological interview; this interview aims to characterize social interactions of the patients, their duration, their evolution and the perception of each participant on this subject.
Experimental: depressed without a history of SA; elderly depressed patients without a history of suicide attempt. interventions: eye tracking, neuropsychological assessment, psychiatric assessment and sociological interview.	Behavioral: eye tracking; 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.; Behavioral: neuropsychological assessement; 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.; Behavioral: psychiatric assessment; 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).; Behavioral: sociological interview; this interview aims to characterize social interactions of the patients, their duration, their evolution and the perception of each participant on this subject.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
antisaccade error rate	1 month max. after inclusion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	1 month max. after inclusion
saccadic intrusion	gaze deviation into a saccade greater than 3° during visual fixation	1 month max. after inclusion
maximal speed of the gaze	maximum speed of visual tracking without triggering any saccade	1 month max. after inclusion
saccade reaction time		1 month max. after inclusion
fixation duration on pictures		1 month max. after inclusion
social interaction quality score		6 month max. after inclusion

Other Outcome Measures

Outcome Measure	Time Frame
neuropsychological test score	1 month max. after inclusion

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Besancon
• Investigators: Principal Investigator: pierre Vandel, MD PhD, Centre Hospitalier Universitaire de Besançon

Study record dates

Study Major Dates

• Study Start (Actual): February 6, 2017
• Primary Completion (Anticipated): August 6, 2019
• Study Completion (Anticipated): February 6, 2020

Study Registration Dates

• First Submitted: August 1, 2016
• First Submitted That Met QC Criteria: August 5, 2016
• First Posted (Estimate): August 8, 2016

Study Record Updates

• Last Update Posted (Actual): October 13, 2017
• Last Update Submitted That Met QC Criteria: October 12, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Keywords: depression; elderly; suicide attempt; cognitive inhibition
• Additional Relevant MeSH Terms: Behavioral Symptoms; Self-Injurious Behavior; Suicide; Suicide, Attempted
• Other Study ID Numbers: P/2016/288

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No