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

NCT ID: NCT02737540

Last Updated: 2021-02-01

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 85 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-08-16
• Study Completion Date: 2020-11-30

Brief Summary

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.

Detailed Description

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.

Conditions

Depressive Disorder, Major

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

No interventions assigned to this group

Healthy subjects

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

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• 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

• 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

• 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

• 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).

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Centre Hospitalier Universitaire de Nīmes

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Fabrice JOLLANT, MD

Role: STUDY_DIRECTOR

Centre Hospitalier Universitaire de Nîmes

Locations

Clinique Les Sophoras

Nîmes, , France

CHRU de Nîmes - Hôpital Universitaire Carémeau

Nîmes, , France

Countries

France

References

Mann JJ. The neurobiology of suicide. Nat Med. 1998 Jan;4(1):25-30. doi: 10.1038/nm0198-025. No abstract available.

Reference Type: BACKGROUND

PMID: 9427602 (View on PubMed)

Other Identifiers

LOCAL/2016/MW-01

Identifier Type: -

Identifier Source: org_study_id