NCT02858427

Brief Summary

The study aims to determine the correlation between the cognitive inhibition impairment and the history of suicide attempt in elderly depressed patients.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2017

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 1, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 8, 2016

Completed
6 months until next milestone

Study Start

First participant enrolled

February 6, 2017

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 6, 2019

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 6, 2020

Completed
Last Updated

October 13, 2017

Status Verified

October 1, 2017

Enrollment Period

2.5 years

First QC Date

August 1, 2016

Last Update Submit

October 12, 2017

Conditions

Keywords

cognitive inhibitionelderlysuicide attemptdepression

Outcome Measures

Primary Outcomes (1)

  • antisaccade error rate

    1 month max. after inclusion

Secondary Outcomes (6)

  • saccade accuracy

    1 month max. after inclusion

  • saccadic intrusion

    1 month max. after inclusion

  • maximal speed of the gaze

    1 month max. after inclusion

  • saccade reaction time

    1 month max. after inclusion

  • fixation duration on pictures

    1 month max. after inclusion

  • +1 more secondary outcomes

Other Outcomes (1)

  • neuropsychological test score

    1 month max. after inclusion

Study Arms (2)

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.

Behavioral: eye trackingBehavioral: neuropsychological assessementBehavioral: psychiatric assessmentBehavioral: 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.

Behavioral: eye trackingBehavioral: neuropsychological assessementBehavioral: psychiatric assessmentBehavioral: sociological interview

Interventions

eye trackingBEHAVIORAL

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.

depressed with suicide attempt (SA)depressed without a history of SA

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.

depressed with suicide attempt (SA)depressed without a history of SA

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).

depressed with suicide attempt (SA)depressed without a history of SA

this interview aims to characterize social interactions of the patients, their duration, their evolution and the perception of each participant on this subject.

depressed with suicide attempt (SA)depressed without a history of SA

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • other psychiatric disease
  • guardianship

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

CHU Besancon

Besançon, Doubs, 25030, France

RECRUITING

CHS Bavilliers

Bavilliers, France

NOT YET RECRUITING

MeSH Terms

Conditions

SuicideSuicide, AttemptedDepression

Condition Hierarchy (Ancestors)

Self-Injurious BehaviorBehavioral SymptomsBehavior

Study Officials

  • pierre vandel, MD PhD

    Centre Hospitalier Universitaire de Besancon

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 1, 2016

First Posted

August 8, 2016

Study Start

February 6, 2017

Primary Completion

August 6, 2019

Study Completion

February 6, 2020

Last Updated

October 13, 2017

Record last verified: 2017-10

Data Sharing

IPD Sharing
Will not share

Locations