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Pain Perception in Suicidal Behavior Vulnerability (DOCS)

This study is currently recruiting participants.
Verified August 2016 by University Hospital, Montpellier
Sponsor:
ClinicalTrials.gov Identifier:
NCT02915679
First Posted: September 27, 2016
Last Update Posted: September 27, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
University Hospital, Montpellier
  Purpose

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).


Condition Intervention
Major Depressive Episode Other: Blood sample for genetic purpose, psychiatric assessment and pain investigation

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Pain Perception in Suicidal Behavior Vulnerability

Further study details as provided by University Hospital, Montpellier:

Primary Outcome Measures:
  • Pain tolerance reported by the patient [ Time Frame: During thermal stimulation ]
    temperature measured when the subject will perceive as intolerable the pain following a painful stimulation performed using a thermode


Secondary Outcome Measures:
  • Pain intensity reported by the patient [ Time Frame: During thermal stimulation ]
    comparison between the three groups of the pain intensity (assessed by likert scale) at constant temperature (43 ° C)

  • Pain threshold reported by the patient [ Time Frame: During thermal stimulation ]
    comparison between the three groups of the pain threshold (temperature perceived as painful)

  • Temperature assessed at 4/10 on likert scale [ Time Frame: During thermal stimulation performed at the inclusion ]
    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.

  • Kinetics of pain intensity [ Time Frame: During thermal stimulation performed at the inclusion ]
    comparison between the three groups of kinetics of pain intensity by visual analog scale (VAS) scale.

  • Social distress perception assessed by social distress questionnaire [ Time Frame: At V2 (one week maximum after the inclusion) ]
    comparison between the three groups of the score of social distress scale after cyberball game

  • Social distress perception assessed by the Rejection Sensitivity Questionnaire (RSQ) [ Time Frame: At the inclusion ]
    comparison between the three groups of the score of social distress scale after cyberball game

  • Social rejection sensitivity assessed by the Rejection Sensitivity Questionnaire (RSQ) [ Time Frame: At the inclusion ]
    comparison between the three groups of the score of social rejection sensitivity by RSQ

  • Psychological pain intensity [ Time Frame: At V2 (one week maximum after the inclusion) ]
    comparison between the three groups of the score of psychological pain intensity assessed by VAS scale.

  • Measure of cardiac frequency in response to thermal pain [ Time Frame: At V2 (one week maximum after the inclusion) ]
    comparison between the three groups of the cardiac frequency.


Estimated Enrollment: 424
Study Start Date: June 2015
Estimated Study Completion Date: January 2017
Estimated Primary Completion Date: January 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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).

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02915679


Contacts
Contact: Emilie OLIE, MD PhD +33 4 67 33 82 89 e-olie@chu-montpellier.fr

Locations
France
Montpellier Hospital University Recruiting
Montpellier, France, 34295
Contact: Catherine GENTY, MD    +33 4 67 99 61 45 75    c-genty@chu-montpellier.fr   
Sponsors and Collaborators
University Hospital, Montpellier
  More Information

Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT02915679     History of Changes
Other Study ID Numbers: UF 9185
2013-A01029-36 ( Other Identifier: Agence Nationale de Sécurité des Médicaments )
First Submitted: August 1, 2016
First Posted: September 27, 2016
Last Update Posted: September 27, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by University Hospital, Montpellier:
Suicidal behavior
psychological and social pain
physical pain
pain perception

Additional relevant MeSH terms:
Depressive Disorder, Major
Depressive Disorder
Mood Disorders
Mental Disorders


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