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).
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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).
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
-
-
-
Montpellier, Francia, 34295
- Montpellier Hospital University
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Altro
- Assegnazione: N / A
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Altro: 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:
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Pain tolerance reported by the patient
Lasso di tempo: 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
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Pain intensity reported by the patient
Lasso di tempo: During thermal stimulation
|
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
Lasso di tempo: During thermal stimulation
|
comparison between the three groups of the pain threshold (temperature perceived as painful)
|
During thermal stimulation
|
|
Temperature assessed at 4/10 on likert scale
Lasso di tempo: 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.
|
During thermal stimulation performed at the inclusion
|
|
Kinetics of pain intensity
Lasso di tempo: 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
|
|
Social distress perception assessed by social distress questionnaire
Lasso di tempo: At V2 (one week maximum after the inclusion)
|
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)
Lasso di tempo: At the inclusion
|
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)
Lasso di tempo: At the inclusion
|
comparison between the three groups of the score of social rejection sensitivity by RSQ
|
At the inclusion
|
|
Psychological pain intensity
Lasso di tempo: At V2 (one week maximum after the inclusion)
|
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
Lasso di tempo: At V2 (one week maximum after the inclusion)
|
comparison between the three groups of the cardiac frequency.
|
At V2 (one week maximum after the inclusion)
|
Collaboratori e investigatori
Sponsor
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Altri numeri di identificazione dello studio
- UF 9185
- 2013-A01029-36 (Altro identificatore: Agence Nationale de Sécurité des Médicaments)
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
prodotto fabbricato ed esportato dagli Stati Uniti
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .