NCT03898648

Brief Summary

Social interactions are part of daily life. To decide to interact with someone or not is a routine for humans. To ensure the quality of interpersonal relationships, emotional cues must be taken into account to adapt optimally the investigator's behavior. Difficulties in interpersonal relationships often trigger suicidal behavior. Suicide attempters are characterized by an impaired decision - making associated with difficulties in familial relationships. To date, little data on emotional recognition and social decision- making in clinical population is available. The study aims to compare behavioral response to negative social cues in 82 depressed patients according to their history of suicide attempt using a computerized neuropsychological task.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
66

participants targeted

Target at P25-P50 for not_applicable depression

Timeline
Completed

Started Apr 2019

Typical duration for not_applicable depression

Geographic Reach
1 country

1 active site

Status
terminated

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

March 29, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 2, 2019

Completed
7 days until next milestone

Study Start

First participant enrolled

April 9, 2019

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 10, 2021

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 10, 2021

Completed
Last Updated

January 5, 2022

Status Verified

December 1, 2021

Enrollment Period

2 years

First QC Date

March 29, 2019

Last Update Submit

December 14, 2021

Conditions

Keywords

DepressionSuicide attemptNeuropsychologyDecision- makingSocial interactionImplicit Emotional processing

Outcome Measures

Primary Outcomes (1)

  • Motivation to avoid anger during the emotional task

    Calculation of the proportion of avoidance vs. approach choices from people expressing anger

    At inclusion

Secondary Outcomes (4)

  • Change in the proportion of avoidant choices in reverse trials compared to normal trials

    At inclusion

  • Reaction time before clicking

    At inclusion

  • Reaction time between first and second choices in reverse tests

    At inclusion

  • Iowa Gambling Test score

    At inclusion

Study Arms (2)

Depressed patients with history of suicide attempt

EXPERIMENTAL

Depressed patients with a lifetime history of suicide attempt will be evaluated regarding their behavioral adaptation toward negative social cues.

Other: Waiting room task

Depressed patients without any history of suicide attempt

EXPERIMENTAL

Depressed patients without history of suicide attempt will be evaluated regarding their behavioral adaptation toward negative social cues.

Other: Waiting room task

Interventions

The waiting room task consists in a computerized neuropsychological task in which the participant is asked to freely choose a chair to sit in a waiting room. In a row of four chairs, the two in the middle are occupied by two males or females. One of the two subjects sitting either has a neutral face, or express a negative emotion (fear or anger). To make their decision, participants must press the "S" keyboard button to go left or the "L" keyboard button to go right in a time limit of 1500 milliseconds. One third of the time, the cursor moves in the opposite direction to that requested by the participant. For example, if the subject presses "S", the cursor moves to the right instead of to the left. Those reverse trials are used to evaluate their motivation to correct the movement of the cursor. The participant will repeat the task 360 times for the assessment to be completed.

Depressed patients with history of suicide attemptDepressed patients without any history of suicide attempt

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Being between 18 and 65 years old
  • Meeting the DSM-5 criteria for a current major depressive disorder
  • For suicidal patients : having a lifetime history of suicide attempt
  • For affective controls : having no personal history of suicide attempt
  • Being able to understand the nature, purpose and methodology of the study
  • Having signed the informed consent
  • Being affiliated to a social security system

You may not qualify if:

  • Current depressive episode with psychotic characteristics
  • Mental retardation or sever medical co-morbidity
  • Lifetime Diagnosis of schizophrenia or schizoaffective disorder
  • Current manic or hypomanic episode
  • Sensory or cognitive disability
  • Pregnant or breastfeeding woman
  • Deprivation of liberty (by judicial or administrative decision)
  • Protection by law (guardianship or curatorship)
  • Inability to understand, speak and write French

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Uhmontpellier

Montpellier, 34295, France

Location

MeSH Terms

Conditions

DepressionSuicide, Attempted

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorSuicideSelf-Injurious Behavior

Study Design

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

Study Record Dates

First Submitted

March 29, 2019

First Posted

April 2, 2019

Study Start

April 9, 2019

Primary Completion

April 10, 2021

Study Completion

October 10, 2021

Last Updated

January 5, 2022

Record last verified: 2021-12

Locations