Pain Perception in Suicidal Behavior Vulnerability (DOCS)

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).

Study Overview

• Status: Terminated
• Conditions: Major Depressive Episode
• Intervention / Treatment: Other: Blood sample for genetic purpose, psychiatric assessment and pain investigation

Detailed 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).

• Study Type: Interventional
• Enrollment (Actual): 167
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Montpellier, France, 34295
    • Montpellier Hospital University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: Study participant; All 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

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Pain threshold reported by the patient	comparison between the three groups of the pain threshold (temperature perceived as painful)	During thermal stimulation
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
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
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)
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
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
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)
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)

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier

Study record dates

Study Major Dates

• Study Start: June 17, 2015
• Primary Completion (Actual): May 6, 2021
• Study Completion (Actual): May 6, 2021

Study Registration Dates

• First Submitted: August 1, 2016
• First Submitted That Met QC Criteria: September 23, 2016
• First Posted (Estimate): September 27, 2016

Study Record Updates

• Last Update Posted (Actual): January 11, 2022
• Last Update Submitted That Met QC Criteria: December 20, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: Suicidal behavior; pain perception; psychological and social pain; physical pain
• Other Study ID Numbers: UF 9185; 2013-A01029-36 (Other Identifier: Agence Nationale de Sécurité des Médicaments)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No