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).
Přehled studie
Postavení
Podmínky
Detailní popis
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).
Typ studie
Zápis (Aktuální)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
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-
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Montpellier, Francie, 34295
- Montpellier Hospital University
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-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Jiný
- Přidělení: N/A
- Intervenční model: Přiřazení jedné skupiny
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Jiný: Study participant
All the participants performed blood sample for genetic purpose, psychiatric assessment and pain investigation:
|
All the participant will performed the same evaluation and blood analysis:
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Pain tolerance reported by the patient
Časové okno: During thermal stimulation
|
temperature measured when the subject will perceive as intolerable the pain following a painful stimulation performed using a thermode
|
During thermal stimulation
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Pain intensity reported by the patient
Časové okno: During thermal stimulation
|
comparison between the three groups of the pain intensity (assessed by likert scale) at constant temperature (43 ° C)
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During thermal stimulation
|
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Pain threshold reported by the patient
Časové okno: During thermal stimulation
|
comparison between the three groups of the pain threshold (temperature perceived as painful)
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During thermal stimulation
|
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Temperature assessed at 4/10 on likert scale
Časové okno: 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.
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During thermal stimulation performed at the inclusion
|
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Kinetics of pain intensity
Časové okno: During thermal stimulation performed at the inclusion
|
comparison between the three groups of kinetics of pain intensity by visual analog scale (VAS) scale.
|
During thermal stimulation performed at the inclusion
|
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Social distress perception assessed by social distress questionnaire
Časové okno: At V2 (one week maximum after the inclusion)
|
comparison between the three groups of the score of social distress scale after cyberball game
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At V2 (one week maximum after the inclusion)
|
|
Social distress perception assessed by the Rejection Sensitivity Questionnaire (RSQ)
Časové okno: At the inclusion
|
comparison between the three groups of the score of social distress scale after cyberball game
|
At the inclusion
|
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Social rejection sensitivity assessed by the Rejection Sensitivity Questionnaire (RSQ)
Časové okno: At the inclusion
|
comparison between the three groups of the score of social rejection sensitivity by RSQ
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At the inclusion
|
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Psychological pain intensity
Časové okno: At V2 (one week maximum after the inclusion)
|
comparison between the three groups of the score of psychological pain intensity assessed by VAS scale.
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At V2 (one week maximum after the inclusion)
|
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Measure of cardiac frequency in response to thermal pain
Časové okno: At V2 (one week maximum after the inclusion)
|
comparison between the three groups of the cardiac frequency.
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At V2 (one week maximum after the inclusion)
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Spolupracovníci a vyšetřovatelé
Sponzor
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Odhad)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další identifikační čísla studie
- UF 9185
- 2013-A01029-36 (Jiný identifikátor: Agence Nationale de Sécurité des Médicaments)
Plán pro data jednotlivých účastníků (IPD)
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