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

28. januar 2021 oppdatert av: 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.

Studieoversikt

Status

Avsluttet

Detaljert beskrivelse

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

Observasjonsmessig

Registrering (Faktiske)

85

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

60 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Ja

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

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.

Beskrivelse

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).

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Kohorter og intervensjoner

Gruppe / Kohort
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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tidsramme
Trust Game
Tidsramme: Days 1-7
Days 1-7
Ultimatum Game
Tidsramme: Days 1-7
Days 1-7
Iowa Gambling Task
Tidsramme: Days 1-7
Days 1-7

Sekundære resultatmål

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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Etterforskere

  • Studieleder: Fabrice JOLLANT, MD, Centre Hospitalier Universitaire de Nīmes

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

16. august 2017

Primær fullføring (Faktiske)

1. august 2020

Studiet fullført (Faktiske)

30. november 2020

Datoer for studieregistrering

Først innsendt

8. april 2016

Først innsendt som oppfylte QC-kriteriene

8. april 2016

Først lagt ut (Anslag)

14. april 2016

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

1. februar 2021

Siste oppdatering sendt inn som oppfylte QC-kriteriene

28. januar 2021

Sist bekreftet

1. januar 2021

Mer informasjon

Begreper knyttet til denne studien

Andre studie-ID-numre

  • LOCAL/2016/MW-01

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