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Neuropsychological Factors Associated With Vulnerability to Suicidal Behavior in Depressed Elderly Patients (SPAD)

28 januari 2021 bijgewerkt door: Centre Hospitalier Universitaire de Nīmes
The main objective of this study is to confirm the existence of risky decision making in a non strategic situation (Iowa Gambling Task) and a deficit of decision making in social situations, linked to greater sensitivity to injustice (Ultimatum Game) and a lower level of trust (Trust Game) in elderly depressed patients with a history of suicide attempts in comparison with older depressed patients without a history of suicidal acts and healthy subjects.

Studie Overzicht

Toestand

Beëindigd

Gedetailleerde beschrijving

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.

Studietype

Observationeel

Inschrijving (Werkelijk)

85

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

      • Nîmes, Frankrijk, 30000
        • Clinique Les Sophoras
      • Nîmes Cedex 09, Frankrijk, 30029
        • CHRU de Nîmes - Hôpital Universitaire Carémeau

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

60 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Ja

Geslachten die in aanmerking komen voor studie

Allemaal

Bemonsteringsmethode

Niet-waarschijnlijkheidssteekproef

Studie Bevolking

The 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 over 60 years, not depressed and without personal history of severe mental illness or suicide attempts will also be recruited.

Beschrijving

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).

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Cohorten en interventies

Groep / Cohort
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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Tijdsspanne
Trust Game
Tijdsspanne: Days 1-7
Days 1-7
Ultimatum Game
Tijdsspanne: Days 1-7
Days 1-7
Iowa Gambling Task
Tijdsspanne: Days 1-7
Days 1-7

Secundaire uitkomstmaten

Uitkomstmaat
Tijdsspanne
Stroop Victoria Test
Tijdsspanne: Days 1-7
Days 1-7
Incompatibility Test
Tijdsspanne: Days 1-7
Days 1-7
Flexibility test
Tijdsspanne: Days 1-7
Days 1-7
Go-NoGo
Tijdsspanne: Days 1-7
Days 1-7
Working memory - TEA
Tijdsspanne: Days 1-7
Days 1-7
Mood Disorders Insight Scale
Tijdsspanne: Days 1-7
Days 1-7
Verbal fluency test
Tijdsspanne: Days 1-7
Days 1-7
Future autobiographical fluency task
Tijdsspanne: Days 1-7
Days 1-7
Bristol Emotion Recognition Test
Tijdsspanne: Days 1-7
Days 1-7
Cognitive Emotion Regulation Questionnaire
Tijdsspanne: Days 1-7
Days 1-7
Questionnaire on negative attitudes towards problems
Tijdsspanne: Days 1-7
Days 1-7
Revised self-awareness scale, Self-reference task
Tijdsspanne: Days 1-7
Days 1-7
Balanced Temporal Perspective Scale
Tijdsspanne: Days 1-7
Days 1-7
Suicide attempt within 6 months of follow-up
Tijdsspanne: Month 6
Month 6

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Onderzoekers

  • Studie directeur: Fabrice JOLLANT, MD, Centre Hospitalier Universitaire de Nîmes

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

16 augustus 2017

Primaire voltooiing (Werkelijk)

1 augustus 2020

Studie voltooiing (Werkelijk)

30 november 2020

Studieregistratiedata

Eerst ingediend

8 april 2016

Eerst ingediend dat voldeed aan de QC-criteria

8 april 2016

Eerst geplaatst (Schatting)

14 april 2016

Updates van studierecords

Laatste update geplaatst (Werkelijk)

1 februari 2021

Laatste update ingediend die voldeed aan QC-criteria

28 januari 2021

Laatst geverifieerd

1 januari 2021

Meer informatie

Termen gerelateerd aan deze studie

Andere studie-ID-nummers

  • LOCAL/2016/MW-01

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