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Behavioral Adaptation to Negative Social Cues in Depressed Patients According to Personal History of Suicide Attempt- COMPASS (COMPASS)

Primary Purpose

Depression, History of Suicide Attempt

Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Waiting room task
Sponsored by
University Hospital, Montpellier
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Depression focused on measuring Depression, Suicide attempt, Neuropsychology, Decision- making, Social interaction, Implicit Emotional processing

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)
  • Exclusion period in relation to another protocol
  • Inability to understand, speak and write French

Sites / Locations

  • Uhmontpellier

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Depressed patients with history of suicide attempt

Depressed patients without any history of suicide attempt

Arm Description

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

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

Outcomes

Primary Outcome Measures

Motivation to avoid anger during the emotional task
Calculation of the proportion of avoidance vs. approach choices from people expressing anger

Secondary Outcome Measures

Change in the proportion of avoidant choices in reverse trials compared to normal trials
Computerized calculation of the proportion of avoidance choices in reverse trials and comparison to the proportion calculated in normal trials.
Reaction time before clicking
Computerized measurement of reaction time before clicking to make the avoidant or approach choice
Reaction time between first and second choices in reverse tests
Computerized measurement of reaction time between the first choice and the second choice during the reverse condition
Iowa Gambling Test score
Decision- making impairment assessment with the Iowa Gambling Task. In this task participants are asked to choose between four piles of cards allowing them to earn or lose money. - Among those piles, two are advantageous (little gain and little loss) while the other two are disadvantageous (bigger gain but bigger loss). The goal is to earn as much money as possible. Persistence to choose the disadvantageous piles is interpreted to reflect impulsivity.

Full Information

First Posted
March 29, 2019
Last Updated
December 14, 2021
Sponsor
University Hospital, Montpellier
Collaborators
INSERM U960 - Cognitive Neuroscience Laboratory - Paris, France
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1. Study Identification

Unique Protocol Identification Number
NCT03898648
Brief Title
Behavioral Adaptation to Negative Social Cues in Depressed Patients According to Personal History of Suicide Attempt- COMPASS
Acronym
COMPASS
Official Title
Behavioral Adaptation to Negative Social Cues in Depressed Patients According to Personal History of Suicide Attempt
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Terminated
Why Stopped
the follow up of the last patient has been done
Study Start Date
April 9, 2019 (Actual)
Primary Completion Date
April 10, 2021 (Actual)
Study Completion Date
October 10, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Montpellier
Collaborators
INSERM U960 - Cognitive Neuroscience Laboratory - Paris, France

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
To identify the nature of the mechanisms involved in social decisions, Mennella and coll. have developed a computerized task (waiting room task) in which the participant is asked to avoid or to approach individuals expressing negative emotional expressions, in this case: anger or fear. In practice, participants have to choose between two chairs to sit in a waiting room in which subjects expressing a neutral face or negative emotions are present. To make this choice they must press a specific keyboard button. In addition to that, in order to evaluate motivation, some of the trials are reversed, meaning that the choice made by the participant will result in the opposite result. Using this task they have shown that: (1) anger is associated with more avoidance behavior than fear, (2) this behavior is goal- directed and, (3) the higher the level of impulsivity of the subjects, the less able they are to adapt their responses. The proposed study will use this neuropsychological assessment, the waiting room task, to evaluate if depressed patients would avoid or approach individuals expressing negative facial emotions. The main objective is to compare behavioral adaptation to anger vs neutral cues among depressed patients with and without history of suicide attempt. The study also aims to : compare behavioral response to fear vs. neutral and anger vs. fear in depressed patients according to suicidal history ; assess the modulation of behavioral adaptation by history of childhood maltreatment, level of impulsivity, anxiodepression and anhedonia; correlate behavioral adaptation to negative cues (anger and fear) with decision-making performances using the Iowa Gambling Task. The hypothesis is that depressed patients with a history of suicide attempt will exhibit anger specific hyper-responsiveness resulting in an increased avoidance behavior compared to subjects without suicidal history. It is expected that depressed suicide attempters will not have a different emotional reactivity compared to patients without suicidal history for another negative emotion, namely fear. To that purpose, 82 depressed patients will be recruited in the study. Half of them will have a history of suicide attempt (suicide attempters) while the other half will have none (affective controls). Their participation will consist of an unique visit.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, History of Suicide Attempt
Keywords
Depression, Suicide attempt, Neuropsychology, Decision- making, Social interaction, Implicit Emotional processing

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
66 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Depressed patients with history of suicide attempt
Arm Type
Experimental
Arm Description
Depressed patients with a lifetime history of suicide attempt will be evaluated regarding their behavioral adaptation toward negative social cues.
Arm Title
Depressed patients without any history of suicide attempt
Arm Type
Experimental
Arm Description
Depressed patients without history of suicide attempt will be evaluated regarding their behavioral adaptation toward negative social cues.
Intervention Type
Other
Intervention Name(s)
Waiting room task
Intervention Description
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.
Primary Outcome Measure Information:
Title
Motivation to avoid anger during the emotional task
Description
Calculation of the proportion of avoidance vs. approach choices from people expressing anger
Time Frame
At inclusion
Secondary Outcome Measure Information:
Title
Change in the proportion of avoidant choices in reverse trials compared to normal trials
Description
Computerized calculation of the proportion of avoidance choices in reverse trials and comparison to the proportion calculated in normal trials.
Time Frame
At inclusion
Title
Reaction time before clicking
Description
Computerized measurement of reaction time before clicking to make the avoidant or approach choice
Time Frame
At inclusion
Title
Reaction time between first and second choices in reverse tests
Description
Computerized measurement of reaction time between the first choice and the second choice during the reverse condition
Time Frame
At inclusion
Title
Iowa Gambling Test score
Description
Decision- making impairment assessment with the Iowa Gambling Task. In this task participants are asked to choose between four piles of cards allowing them to earn or lose money. - Among those piles, two are advantageous (little gain and little loss) while the other two are disadvantageous (bigger gain but bigger loss). The goal is to earn as much money as possible. Persistence to choose the disadvantageous piles is interpreted to reflect impulsivity.
Time Frame
At inclusion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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) Exclusion period in relation to another protocol Inability to understand, speak and write French
Facility Information:
Facility Name
Uhmontpellier
City
Montpellier
ZIP/Postal Code
34295
Country
France

12. IPD Sharing Statement

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Behavioral Adaptation to Negative Social Cues in Depressed Patients According to Personal History of Suicide Attempt- COMPASS

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