Study Stopped
difficulty in recruiting
Pain Perception in Suicidal Behavior Vulnerability
DOCS
2 other identifiers
interventional
167
1 country
1
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2015
Longer than P75 for not_applicable
1 active site
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
Study Start
First participant enrolled
June 17, 2015
CompletedFirst Submitted
Initial submission to the registry
August 1, 2016
CompletedFirst Posted
Study publicly available on registry
September 27, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 6, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
May 6, 2021
CompletedJanuary 11, 2022
December 1, 2021
5.9 years
August 1, 2016
December 20, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (9)
Pain intensity reported by the patient
During thermal stimulation
Pain threshold reported by the patient
During thermal stimulation
Temperature assessed at 4/10 on likert scale
During thermal stimulation performed at the inclusion
Kinetics of pain intensity
During thermal stimulation performed at the inclusion
Social distress perception assessed by social distress questionnaire
At V2 (one week maximum after the inclusion)
- +4 more secondary outcomes
Study Arms (1)
Study participant
OTHERAll the participants performed blood sample for genetic purpose, psychiatric assessment and pain investigation: * 81 depressed patients admitted after a recent suicidal act (\<8 days) * 81 depressed subjects with a past history of suicidal act (\>1month) * 80 depressed subjects without any personal history of suicidal behaviour
Interventions
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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Montpellier Hospital University
Montpellier, 34295, France
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 1, 2016
First Posted
September 27, 2016
Study Start
June 17, 2015
Primary Completion
May 6, 2021
Study Completion
May 6, 2021
Last Updated
January 11, 2022
Record last verified: 2021-12
Data Sharing
- IPD Sharing
- Will not share