NCT02915679

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

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
167

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

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

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

August 1, 2016

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 27, 2016

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 6, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 6, 2021

Completed
Last Updated

January 11, 2022

Status Verified

December 1, 2021

Enrollment Period

5.9 years

First QC Date

August 1, 2016

Last Update Submit

December 20, 2021

Conditions

Keywords

Suicidal behaviorpsychological and social painphysical painpain perception

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

OTHER

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

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

Study participant

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Location

MeSH Terms

Interventions

Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

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

Locations