- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT02737540
Neuropsychological Factors Associated With Vulnerability to Suicidal Behavior in Depressed Elderly Patients (SPAD)
Aperçu de l'étude
Statut
Les conditions
Description détaillée
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.
Type d'étude
Inscription (Réel)
Contacts et emplacements
Lieux d'étude
-
-
-
Nîmes, France, 30000
- Clinique Les Sophoras
-
Nîmes Cedex 09, France, 30029
- CHRU de Nîmes - Hôpital Universitaire Carémeau
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
La description
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 d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / 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.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
|---|---|
|
Trust Game
Délai: Days 1-7
|
Days 1-7
|
|
Ultimatum Game
Délai: Days 1-7
|
Days 1-7
|
|
Iowa Gambling Task
Délai: Days 1-7
|
Days 1-7
|
Mesures de résultats secondaires
Mesure des résultats |
Délai |
|---|---|
|
Stroop Victoria Test
Délai: Days 1-7
|
Days 1-7
|
|
Incompatibility Test
Délai: Days 1-7
|
Days 1-7
|
|
Flexibility test
Délai: Days 1-7
|
Days 1-7
|
|
Go-NoGo
Délai: Days 1-7
|
Days 1-7
|
|
Working memory - TEA
Délai: Days 1-7
|
Days 1-7
|
|
Mood Disorders Insight Scale
Délai: Days 1-7
|
Days 1-7
|
|
Verbal fluency test
Délai: Days 1-7
|
Days 1-7
|
|
Future autobiographical fluency task
Délai: Days 1-7
|
Days 1-7
|
|
Bristol Emotion Recognition Test
Délai: Days 1-7
|
Days 1-7
|
|
Cognitive Emotion Regulation Questionnaire
Délai: Days 1-7
|
Days 1-7
|
|
Questionnaire on negative attitudes towards problems
Délai: Days 1-7
|
Days 1-7
|
|
Revised self-awareness scale, Self-reference task
Délai: Days 1-7
|
Days 1-7
|
|
Balanced Temporal Perspective Scale
Délai: Days 1-7
|
Days 1-7
|
|
Suicide attempt within 6 months of follow-up
Délai: Month 6
|
Month 6
|
Collaborateurs et enquêteurs
Les enquêteurs
- Directeur d'études: Fabrice JOLLANT, MD, Centre Hospitalier Universitaire de Nîmes
Publications et liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- LOCAL/2016/MW-01
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .