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

28 januari 2021 uppdaterad 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.

Studieöversikt

Status

Avslutad

Detaljerad beskrivning

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.

Studietyp

Observationell

Inskrivning (Faktisk)

85

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

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

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

60 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Ja

Kön som är behöriga för studier

Allt

Testmetod

Icke-sannolikhetsprov

Studera befolkning

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.

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Kohorter och interventioner

Grupp / 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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Tidsram
Trust Game
Tidsram: Days 1-7
Days 1-7
Ultimatum Game
Tidsram: Days 1-7
Days 1-7
Iowa Gambling Task
Tidsram: Days 1-7
Days 1-7

Sekundära resultatmått

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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Utredare

  • Studierektor: Fabrice JOLLANT, MD, Centre Hospitalier Universitaire de Nîmes

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

16 augusti 2017

Primärt slutförande (Faktisk)

1 augusti 2020

Avslutad studie (Faktisk)

30 november 2020

Studieregistreringsdatum

Först inskickad

8 april 2016

Först inskickad som uppfyllde QC-kriterierna

8 april 2016

Första postat (Uppskatta)

14 april 2016

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

1 februari 2021

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

28 januari 2021

Senast verifierad

1 januari 2021

Mer information

Termer relaterade till denna studie

Andra studie-ID-nummer

  • LOCAL/2016/MW-01

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