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

This study is currently recruiting participants.
Verified October 2017 by Centre Hospitalier Universitaire de Besancon
Sponsor:
ClinicalTrials.gov Identifier:
NCT02858427
First Posted: August 8, 2016
Last Update Posted: October 13, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Besancon
  Purpose
The study aims to determine the correlation between the cognitive inhibition impairment and the history of suicide attempt in elderly depressed patients.

Condition Intervention
Suicide Behavioral: eye tracking Behavioral: neuropsychological assessement Behavioral: psychiatric assessment Behavioral: sociological interview

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Cognitive Inhibition Impairment and Suicide Attempt in Elderly: Eye Tracking Characterization and Impact of Psychosocial Interactions

Resource links provided by NLM:


Further study details as provided by Centre Hospitalier Universitaire de Besancon:

Primary Outcome Measures:
  • antisaccade error rate [ Time Frame: 1 month max. after inclusion ]

Secondary Outcome Measures:
  • saccade accuracy [ Time Frame: 1 month max. after inclusion ]
    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 [ Time Frame: 1 month max. after inclusion ]
    gaze deviation into a saccade greater than 3° during visual fixation

  • maximal speed of the gaze [ Time Frame: 1 month max. after inclusion ]
    maximum speed of visual tracking without triggering any saccade

  • 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 ]

Other Outcome Measures:
  • neuropsychological test score [ Time Frame: 1 month max. after inclusion ]

Estimated Enrollment: 36
Actual Study Start Date: February 6, 2017
Estimated Study Completion Date: February 6, 2020
Estimated Primary Completion Date: August 6, 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02858427


Contacts
Contact: julie monnin, PhD 0033381218543 jmonnin@chu-besancon.fr
Contact: kristina mouyabi 0033381218356 kmouyabi@chu-besancon.fr

Locations
France
CHU Besancon Recruiting
Besancon, Doubs, France, 25030
Contact: Julie Monnin, PhD    00033381218543    jmonnin@chu-besancon.fr   
CHS Bavilliers Not yet recruiting
Bavilliers, France
Contact: Julie MONNIN, PhD       jmonnin@chu-besancon.fr   
Principal Investigator: Caroline MASSE-SIBILLE, MD         
Sponsors and Collaborators
Centre Hospitalier Universitaire de Besancon
Investigators
Principal Investigator: pierre vandel, MD PhD Centre Hospitalier Universitaire de Besancon
  More Information

Responsible Party: Centre Hospitalier Universitaire de Besancon
ClinicalTrials.gov Identifier: NCT02858427     History of Changes
Other Study ID Numbers: P/2016/288
First Submitted: August 1, 2016
First Posted: August 8, 2016
Last Update Posted: October 13, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Centre Hospitalier Universitaire de Besancon:
cognitive inhibition
elderly
suicide attempt
depression

Additional relevant MeSH terms:
Suicide
Suicide, Attempted
Self-Injurious Behavior
Behavioral Symptoms