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Electrodermal Hyporeactivity And Depression (EUDOR-A)

26 de septiembre de 2016 actualizado por: University Hospital, Montpellier

Naturalistic Clinical Studies in Several Centres of Electrodermal Hyporeactivity in Adult Patients With Primary Depression

Suicide, suicide attempts and depression are major social problems. The present research program focuses on the relationship between electrodermal hyporeactivity, as measured by the ElectroDermal Orienting Reactivity (EDOR) Test, and suicide and suicide attempts with death intent in patients with a primary diagnosis of depression. Electrodermal hyporeactivity has in several publications from different laboratories repeatedly been shown to have a high sensitivity (up to 97%) and high raw specificity (up to 98%) for suicide. Such levels are unique in psychiatry. The relationship between suicidal propensity and hyporeactivity can be considered as strongly significant. Almost all evidence in the topic up today has been established in research settings with specific exclusion criteria for some secondary psychiatric and some somatic illnesses. However, it is important to study the relationship between electrodermal hyporeactivity and suicide in relatively unselected patients regarding secondary psychiatric diagnoses and somatic diagnoses in a natural clinical ward situation and milieu. A previous naturalistic study proved that a test of electrodermal hyporeactivity fits very well into the daily clinical work.

Descripción general del estudio

Estado

Desconocido

Condiciones

Intervención / Tratamiento

Descripción detallada

This EUDOR-A study is a naturalistic, european and multicentric study. In France, patient's recruitment will be only conducted by investigators within the Department of Psychiatric Emergencies and Post Acute Care, University Hospital of Montpellier.

Over one year, 233 patients suffering from a major depressive episode with (n=70) and without any history of suicide attempt (n=163) will be recruited.

The maximum period of participation for a given patient will be 12 months with 2 phone assessments at 6 month and 12 month.

Inclusion visit: clinical and biological assessment and Edor test. Second and third visits at 6 and 12 month: Follow up visits in the department or interview by telephone in order to assess suicidal ideations or suicide attempts since the inclusion.

Tipo de estudio

Intervencionista

Inscripción (Actual)

112

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

  • Francia
      • Montpellier, Francia, 34295
        • Montpellier University Hospital

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion criteria:

All subjects men and women will necessarily meet the following inclusion criteria:

  • In- and outpatients, with a diagnosis of primary depression according to the International classification of Disease (ICD-10) should be included as a routine. That is, patients in a primary unipolar major episode or dysthymia or primary depression with a personality disorder or an anxiety disorder as secondary diagnoses and primary bipolar disorder in a non-hypomanic and non-manic phase are expected to be included.
  • Age : 18 years or older
  • written informed consent
  • must belong to social safety system
  • To be able to understand instructions for the EDOR Test, the aim and the methodology of the study.

Exclusion criteria:

  • diagnosed or suspected dementia
  • Acute known or suspected alcohol or other substance abuse. The condition of past substance abuse (i.e. alcohol abuse or dependance, drug abuse or dependance ) should be noted in the comment field of the EDOR Test routine and patient must have been abstinent for at least one year.
  • Serious problems of hearing, the patient should not participate.
  • Refusal of participation
  • Subject deprived of liberty (by judicial or administrative decision)
  • Subject protected by law.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Diagnóstico
  • Asignación: N / A
  • Modelo Intervencionista: Asignación de un solo grupo
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Depressive patients
EDOR test on depressed patients with or without personal history of suicidal behavior
Dispositivo: EDOR test

The ElectroDermal Orienting Reactivity (EDOR) specifically is optimized for the detection of electrodermal hyporeactivity.

The EDOR investigation last about 30 min. The EDOR Test Data is sent immediately after each EDOR Test for each Test Person to a Company named EMOTRA for blind analyses. The EDOR Test Report may change the basis for the assessment and a new risk assessment may be needed to be done.

Blood sample and clinical assessment

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Specificity and sensibility of the electrodermal hyporeactivity
Periodo de tiempo: At 6 and 12 month
Correlation between the Edor Test results and suicidal behavior
At 6 and 12 month

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
The sensibility of the electrodermal hyporeactivity compared with the occurrence of the violent suicidal attempt measured by Columbia-Suicide Severity Rating Scale (C-SSRS)
Periodo de tiempo: At 6 month
Comparison of test result between patients with history of violent suicidal attempt and patients with history of non violent suicidal
At 6 month
The sensibility of the electrodermal hyporeactivity compared with the occurrence of the violent suicidal attempt measured by Columbia-Suicide Severity Rating Scale (C-SSRS)
Periodo de tiempo: At 6 and 12 month
Comparison of test result between patients with history of violent suicidal attempt and patients with history of non violent suicidal
At 6 and 12 month
Electrodermal activity in depressive and suicidal patients with or without insomnia.
Periodo de tiempo: At 6 and 12 month
Comparison of test result between patients with insomnia and patient without insomnia. Insomnia will be evaluated with the "Insomnia severity index" (ISI).
At 6 and 12 month
Genetic vulnerability to suicidal behavior by polymorphism analysis in blood sample
Periodo de tiempo: At the inclusion
To study the polymorphisms by blood sample analysis of the promotor of Spermidine/Spermine Acetyltransferase 1 (SAT1), Phenylethanolamine N-Methyltransferase (PNMT) and Noradrenalin Transporter (NAT). between depressed patients with suicidal behavior and depressed patients without suicidal behavior.
At the inclusion
The sensibility of the electrodermal hyporeactivity compared with the occurrence of the violent suicidal attempt measured by Risk Rescue Rating Scale (RRRS)
Periodo de tiempo: At 6 and 12 month
Comparison of test result between patients with history of violent suicidal attempt and patients with history of non violent suicidal
At 6 and 12 month
The sensibility of the electrodermal hyporeactivity compared with the occurrence of the violent suicidal attempt measured by Beck Scale for Suicidal Intent (SIS).
Periodo de tiempo: At 6 and 12 month
Comparison of test result between patients with history of violent suicidal attempt and patients with history of non violent suicidal
At 6 and 12 month

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

University Hospital, Montpellier

Colaboradores

University of Molise
EMOTRA-AB, Göteborgsvagen 74, 433 63 Sävedalen, Sweden

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio

1 de marzo de 2015

Finalización primaria (Anticipado)

1 de marzo de 2017

Finalización del estudio (Anticipado)

1 de marzo de 2017

Fechas de registro del estudio

Enviado por primera vez

20 de julio de 2016

Primero enviado que cumplió con los criterios de control de calidad

26 de septiembre de 2016

Publicado por primera vez (Estimar)

27 de septiembre de 2016

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

27 de septiembre de 2016

Última actualización enviada que cumplió con los criterios de control de calidad

26 de septiembre de 2016

Última verificación

1 de julio de 2016

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • UF 9464
  • 2014-A01310-47 (Otro identificador: Agence Nationale de sécurité des Médicaments)

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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