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

28. Januar 2021 aktualisiert von: 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.

Studienübersicht

Status

Beendet

Detaillierte Beschreibung

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.

Studientyp

Beobachtungs

Einschreibung (Tatsächlich)

85

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

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

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

60 Jahre und älter (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Ja

Studienberechtigte Geschlechter

Alle

Probenahmeverfahren

Nicht-Wahrscheinlichkeitsprobe

Studienpopulation

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.

Beschreibung

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).

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

Kohorten und Interventionen

Gruppe / Kohorte
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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Zeitfenster
Trust Game
Zeitfenster: Days 1-7
Days 1-7
Ultimatum Game
Zeitfenster: Days 1-7
Days 1-7
Iowa Gambling Task
Zeitfenster: Days 1-7
Days 1-7

Sekundäre Ergebnismessungen

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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Ermittler

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

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

16. August 2017

Primärer Abschluss (Tatsächlich)

1. August 2020

Studienabschluss (Tatsächlich)

30. November 2020

Studienanmeldedaten

Zuerst eingereicht

8. April 2016

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

8. April 2016

Zuerst gepostet (Schätzen)

14. April 2016

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

1. Februar 2021

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

28. Januar 2021

Zuletzt verifiziert

1. Januar 2021

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Andere Studien-ID-Nummern

  • LOCAL/2016/MW-01

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