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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02915679
Other study ID # UF 9185
Secondary ID 2013-A01029-36
Status Terminated
Phase N/A
First received
Last updated
Start date June 17, 2015
Est. completion date May 6, 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

In France, almost 1 death on 50 is a suicide. The suicide occurs in unbearable psychic pain where mental trouble has a major influence. It is classified as preventable mortality. According to interpersonal psychological theory of suicide, the repeated exposition to stressful and painful events (as physical abuse) would facilitate suicide attempt through the increased pain tolerance. The social pain (or psychical pain on the broader sense) and physical pain are closely linked. The investigators hypothesize that the measure of painful perception will be significantly superior on suicidals attempters compared to non-attempters. It will be the case for recent suicide attempters and former suicide attempters, suggesting a suicidal vulnerability trait. Moreover, the investigators expect that social distress induced by a social exclusion paradigm will be significantly superior on suicide attempters compared to non-attempters. The aim of the study is to investigate the physical and psychic pain on depressed subjects with or without history of suicide attempts. After a clinical evaluation (psychiatric symptomatology, personality trait, suicidal dimension), subjects will be submitted to a painful thermic stimulation and will participate at a computer test of social exclusion (named Cyberball).


Description:

242 depressed patients ( 81 recent suicide attempters, 81 former suicide attempters, 80 non-attempters) First visit : clinical assessment Second visit : pain evaluation and blood sample (from one day to a week maximum after the first visit).


Recruitment information / eligibility

Status Terminated
Enrollment 167
Est. completion date May 6, 2021
Est. primary completion date May 6, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion criteria: - aged by 18 years old - came from West Europe, excepted Basque and Sardinian (because of genetics analysis) - main diagnosis of major depressive episode (DSM V criteria) - not having take antalgics in the 24 hours before assessment - received a minimal psychotrope treatment (clinician evaluation) - Able to understand nature, aims, methodology of the study - Agree to cooperate in clinical and biological assessment - Having signed informed consent Specific inclusion criteria : 81 recent suicide attempters (being hospitalised for suicidal attempts and having realised a suicide attempts 8 days before inclusion) 81 former suicide attempters (having realised in his lifetime a suicide attempt, one month before inclusion) Exclusion criteria: - Current diagnosis of manic, hypomanic or alcohol dependance or substance abuse in the last 6 months, or diagnosis of schizophrenia or schizoaffective disorder in his lifetime - Current algic and chronic neurologic disease - Current or actual treatment by tricyclic antidepressant and Serotonin and norepinephrine reuptake inhibitors(SNRIs) - Pregnancy - Patients on protective measure

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Blood sample for genetic purpose, psychiatric assessment and pain investigation
All the participant will performed the same evaluation and blood analysis: A clinical assessment by psychiatrics assessing psychiatric disorder and suicidal behavior Thermal stimulation for pain assessment Computer game named Cyberball: test of social exclusion Self report questionnaire for the assessment of reject sensitivity, relationship style, impulsivity, childhood trauma. Routine blood sampling

Locations

Country Name City State
France Montpellier Hospital University Montpellier

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Pain tolerance reported by the patient temperature measured when the subject will perceive as intolerable the pain following a painful stimulation performed using a thermode During thermal stimulation
Secondary Pain intensity reported by the patient comparison between the three groups of the pain intensity (assessed by likert scale) at constant temperature (43 ° C) During thermal stimulation
Secondary Pain threshold reported by the patient comparison between the three groups of the pain threshold (temperature perceived as painful) During thermal stimulation
Secondary Temperature assessed at 4/10 on likert scale comparison between the three groups of the temperature assessed at 4/10 on a visual analogic painful scale, kinetics of pain intensity by visual analog scale (VAS) scale. During thermal stimulation performed at the inclusion
Secondary Kinetics of pain intensity comparison between the three groups of kinetics of pain intensity by visual analog scale (VAS) scale. During thermal stimulation performed at the inclusion
Secondary Social distress perception assessed by social distress questionnaire comparison between the three groups of the score of social distress scale after cyberball game At V2 (one week maximum after the inclusion)
Secondary Social distress perception assessed by the Rejection Sensitivity Questionnaire (RSQ) comparison between the three groups of the score of social distress scale after cyberball game At the inclusion
Secondary Social rejection sensitivity assessed by the Rejection Sensitivity Questionnaire (RSQ) comparison between the three groups of the score of social rejection sensitivity by RSQ At the inclusion
Secondary Psychological pain intensity comparison between the three groups of the score of psychological pain intensity assessed by VAS scale. At V2 (one week maximum after the inclusion)
Secondary Measure of cardiac frequency in response to thermal pain comparison between the three groups of the cardiac frequency. At V2 (one week maximum after the inclusion)
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