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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT03898648
Other study ID # RECHMPL19_0024
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date April 9, 2019
Est. completion date October 10, 2021

Study information

Verified date December 2021
Source University Hospital, Montpellier
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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 : 1. compare behavioral response to fear vs. neutral and anger vs. fear in depressed patients according to suicidal history ; 2. assess the modulation of behavioral adaptation by history of childhood maltreatment, level of impulsivity, anxiodepression and anhedonia; 3. 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.


Recruitment information / eligibility

Status Terminated
Enrollment 66
Est. completion date October 10, 2021
Est. primary completion date April 10, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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

Study Design


Intervention

Other:
Waiting room task
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.

Locations

Country Name City State
France Uhmontpellier Montpellier

Sponsors (2)

Lead Sponsor Collaborator
University Hospital, Montpellier INSERM U960 - Cognitive Neuroscience Laboratory - Paris, France

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Motivation to avoid anger during the emotional task Calculation of the proportion of avoidance vs. approach choices from people expressing anger At inclusion
Secondary 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. At inclusion
Secondary Reaction time before clicking Computerized measurement of reaction time before clicking to make the avoidant or approach choice At inclusion
Secondary 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 At inclusion
Secondary 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. At inclusion
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