- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT02915679
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).
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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).
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
-
-
Montpellier, Frankrike, 34295
- Montpellier Hospital University
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Annen
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Annen: 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:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Pain tolerance reported by the patient
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Pain intensity reported by the patient
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: At the inclusion
|
comparison between the three groups of the score of social rejection sensitivity by RSQ
|
At the inclusion
|
Psychological pain intensity
Tidsramme: 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
Tidsramme: 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)
|
Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- UF 9185
- 2013-A01029-36 (Annen identifikator: Agence Nationale de Sécurité des Médicaments)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
produkt produsert i og eksportert fra USA
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
Kliniske studier på Major Depressive Episode
-
Shalvata Mental Health CenterUkjentMAjor depressiv lidelseIsrael
-
Seasons Biotechnology (Taizhou) Co., Ltd.FullførtMajor depressiv lidelse (MDDIndia
-
Gangnam Severance HospitalFullførtMajor depressiv lidelse (MDD)Korea, Republikken
-
Seasons Biotechnology (Taizhou) Co., Ltd.FullførtMajor depressiv lidelse (MDD)India
-
Repurposed Therapeutics, Inc.Ukjent
-
GlaxoSmithKlineFullførtMajor depressiv lidelse (MDD)Forente stater
-
AccexibleRekrutteringMajor depressiv lidelse (MDD)Spania
-
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.Har ikke rekruttert ennåMajor depressiv lidelse (MDD)
-
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.RekrutteringMajor depressiv lidelse (MDD)Kina
-
Seasons Biotechnology (Taizhou) Co., Ltd.FullførtMajor depressiv lidelse (MDD)India