- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02737540
Neuropsychological Factors Associated With Vulnerability to Suicidal Behavior in Depressed Elderly Patients (SPAD)
Descripción general del estudio
Estado
Condiciones
Descripción detallada
The secondary objectives are to confirm or explore the deficits of certain cognitive processes involved in potentially suicidal behavior in depressed elderly persons but that have been little or not studied to date. These include:
A. cognitive control and sensitivity to interference (Victoria Stroop test, incompatibility test, flexibility test, Go / No-Go);
B. Strategic recovery of semantic memory (verbal fluency test);
C. Working memory (TEA);
D. Insight related to depression (Mood Disorders Insight Scale);
E. Recognition of facial emotions;
F. Emotional regulation;
G. Negative attitudes;
H. Self-perception and;
I. Time perspectives.
Finally, patients will be contacted by telephone at month 6 to assess the occurrence of a suicidal act during this period and thus calculate the predictive ability of cognitive and psychological factors.
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
-
Nîmes, Francia, 30000
- Clinique Les Sophoras
-
Nîmes Cedex 09, Francia, 30029
- CHRU de Nîmes - Hôpital Universitaire Carémeau
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
Inclusion criteria for patients:
- The patient or his/her representative must have given his/her informed and signed consent
- The patient must be insured or beneficiary of a health insurance plan
- Patients with a diagnosis of current, moderate to severe, major depressive episode according to the DSM diagnostic criteria 5. This episode can be considered as part of a major depressive disorder or bipolar disorder.
- Patients with or without a personal history of suicide attempts. A suicide attempt is defined as any act performed with some intent to die (Mann 1998). Suicidal threats, aborted or interrupted gestures as well as self-mutilating acts without suicidal intent will not be considered as suicidal acts.
- Patients hospitalized (or followed as outpatients) in the Nîmes University Hospital psychiatry department or the Sophoras clinic in Nimes
Inclusion criteria for healthy subjects:
- The subject or his/her representative must have given his/her informed and signed consent
- The subject must be insured or beneficiary of a health insurance plan
- Non-depressed subject without personal history of lifetime mood disorder or severe mental illness, or substance or alcohol abuse during the past 12 months
Exclusion criteria for patients:
- The patient is participating in another study
- The patient is in an exclusion period determined by a previous study
- The patient is under judicial protection
- The patient (or his/her legal representative) refuses to sign the consent
- It is impossible to correctly inform the patient or his/her legal representative
- The patient has a known MMSE score <24 (elimination of probable dementia pathology)
- Known central neurological disease including degenerative disease, severe head trauma and severe cerebral vascular disease
- Known schizophrenia and other psychotic disorders
- Alcohol or substance abuse in the last 12 months
- Electroconvulsive therapy in the 12 months preceding the study because of the risk of mnesic side effects
- Inability to perform neuropsychological tests because of a language problem, poor understanding, a major tremor, inability to sit still, a major sight problem that can not be corrected, or other severe cognitive impairment
- The subject presents an acute somatic decompensation incompatible with the completion of this study
- The patient has current confusion
Exclusion criteria for healthy subjects:
- The subject is participating in another study
- The subject is in an exclusion period determined by a previous study
- The subject is under judicial protection
- The subject (or his/her legal representative) refuses to sign the consent
- It is impossible to correctly inform the subject or his/her legal representative
- The subject has a known MMSE score <24 (elimination of probable dementia pathology)
- Known central neurological disease including degenerative disease, severe head trauma and severe cerebral vascular disease
- Known schizophrenia and other psychotic disorders
- Alcohol or substance abuse in the last 12 months
- Electroconvulsive therapy in the 12 months preceding the study because of the risk of mnesic side effects
- Inability to perform neuropsychological tests because of a language problem, poor understanding, a major tremor, inability to sit still, a major sight problem that can not be corrected, or other severe cognitive impairment
- The subject has a mood disorder
- The subject presents an acute somatic decompensation incompatible with the completion of this study
- Thesubject has current confusion
Pharmacological treatment is not a criterion for exclusion in itself but it will be left to the judgment of the evaluator to choose to include a subject or not (or to postpone inclusion) depending on the drug (eg. after weaning daytime sedative treatment and benzodiazepines).
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
---|
Major depressive episode
This study population consists of patients over 60 years of age with or without a personal history of suicide attempts, hospitalized in the Nîmes University Hospital psychiatry department or the Sophoras clinic for a major depressive episode.
|
Healthy subjects
Healthy subjects over 60 years, not depressed and without personal history of severe mental illness or suicide attempts will be recruited.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
---|---|
Trust Game
Periodo de tiempo: Days 1-7
|
Days 1-7
|
Ultimatum Game
Periodo de tiempo: Days 1-7
|
Days 1-7
|
Iowa Gambling Task
Periodo de tiempo: Days 1-7
|
Days 1-7
|
Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
---|---|
Stroop Victoria Test
Periodo de tiempo: Days 1-7
|
Days 1-7
|
Incompatibility Test
Periodo de tiempo: Days 1-7
|
Days 1-7
|
Flexibility test
Periodo de tiempo: Days 1-7
|
Days 1-7
|
Go-NoGo
Periodo de tiempo: Days 1-7
|
Days 1-7
|
Working memory - TEA
Periodo de tiempo: Days 1-7
|
Days 1-7
|
Mood Disorders Insight Scale
Periodo de tiempo: Days 1-7
|
Days 1-7
|
Verbal fluency test
Periodo de tiempo: Days 1-7
|
Days 1-7
|
Future autobiographical fluency task
Periodo de tiempo: Days 1-7
|
Days 1-7
|
Bristol Emotion Recognition Test
Periodo de tiempo: Days 1-7
|
Days 1-7
|
Cognitive Emotion Regulation Questionnaire
Periodo de tiempo: Days 1-7
|
Days 1-7
|
Questionnaire on negative attitudes towards problems
Periodo de tiempo: Days 1-7
|
Days 1-7
|
Revised self-awareness scale, Self-reference task
Periodo de tiempo: Days 1-7
|
Days 1-7
|
Balanced Temporal Perspective Scale
Periodo de tiempo: Days 1-7
|
Days 1-7
|
Suicide attempt within 6 months of follow-up
Periodo de tiempo: Month 6
|
Month 6
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Director de estudio: Fabrice JOLLANT, MD, Centre Hospitalier Universitaire de Nīmes
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- LOCAL/2016/MW-01
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. .