- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT02737540
Neuropsychological Factors Associated With Vulnerability to Suicidal Behavior in Depressed Elderly Patients (SPAD)
Panoramica dello studio
Stato
Condizioni
Descrizione dettagliata
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 di studio
Iscrizione (Effettivo)
Contatti e Sedi
Luoghi di studio
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Nîmes, Francia, 30000
- Clinique Les Sophoras
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Nîmes Cedex 09, Francia, 30029
- CHRU de Nîmes - Hôpital Universitaire Carémeau
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
Descrizione
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).
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
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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.
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Healthy subjects
Healthy subjects over 60 years, not depressed and without personal history of severe mental illness or suicide attempts will be recruited.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
---|---|
Trust Game
Lasso di tempo: Days 1-7
|
Days 1-7
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Ultimatum Game
Lasso di tempo: Days 1-7
|
Days 1-7
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Iowa Gambling Task
Lasso di tempo: Days 1-7
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Days 1-7
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Misure di risultato secondarie
Misura del risultato |
Lasso di tempo |
---|---|
Stroop Victoria Test
Lasso di tempo: Days 1-7
|
Days 1-7
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Incompatibility Test
Lasso di tempo: Days 1-7
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Days 1-7
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Flexibility test
Lasso di tempo: Days 1-7
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Days 1-7
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Go-NoGo
Lasso di tempo: Days 1-7
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Days 1-7
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Working memory - TEA
Lasso di tempo: Days 1-7
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Days 1-7
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Mood Disorders Insight Scale
Lasso di tempo: Days 1-7
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Days 1-7
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Verbal fluency test
Lasso di tempo: Days 1-7
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Days 1-7
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Future autobiographical fluency task
Lasso di tempo: Days 1-7
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Days 1-7
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Bristol Emotion Recognition Test
Lasso di tempo: Days 1-7
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Days 1-7
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Cognitive Emotion Regulation Questionnaire
Lasso di tempo: Days 1-7
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Days 1-7
|
Questionnaire on negative attitudes towards problems
Lasso di tempo: Days 1-7
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Days 1-7
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Revised self-awareness scale, Self-reference task
Lasso di tempo: Days 1-7
|
Days 1-7
|
Balanced Temporal Perspective Scale
Lasso di tempo: Days 1-7
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Days 1-7
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Suicide attempt within 6 months of follow-up
Lasso di tempo: Month 6
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Month 6
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Collaboratori e investigatori
Investigatori
- Direttore dello studio: Fabrice JOLLANT, MD, Centre Hospitalier Universitaire de Nīmes
Pubblicazioni e link utili
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
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
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- LOCAL/2016/MW-01
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 .
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