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Trial record 1 of 4 for:    sociological | Not yet recruiting Studies
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Cognitive Inhibition, Psychosocial Interactions and Suicide Attempt in Elderly (OBSUIVAL)

This study is not yet open for participant recruitment.
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Verified August 2016 by Centre Hospitalier Universitaire de Besancon
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Besancon
ClinicalTrials.gov Identifier:
NCT02858427
First received: August 1, 2016
Last updated: August 5, 2016
Last verified: August 2016
  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: 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
Study Start Date: September 2016
Estimated Study Completion Date: September 2019
Estimated Primary Completion Date: March 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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02858427

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

Locations
France
CHU Besancon
Besancon, Doubs, France, 25030
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
Study First Received: August 1, 2016
Last Updated: August 5, 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: 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

ClinicalTrials.gov processed this record on July 26, 2017