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

Depressive Disorder, Major Clinical Trial

— SPAD  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02737540
• Other study ID #: LOCAL/2016/MW-01
• Status: Terminated
• Start date: August 16, 2017
• Est. completion date: November 30, 2020

Study information

• Verified date: January 2021
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 85
• Est. completion date: November 30, 2020
• Est. primary completion date: August 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Depressive Disorder
• Depressive Disorder, Major

Locations

Country	Name	City	State
France	Clinique Les Sophoras	Nîmes
France	CHRU de Nîmes - Hôpital Universitaire Carémeau	Nîmes Cedex 09

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

References & Publications (1)

Mann JJ. The neurobiology of suicide. Nat Med. 1998 Jan;4(1):25-30. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Trust Game		Days 1-7
Primary	Ultimatum Game		Days 1-7
Primary	Iowa Gambling Task		Days 1-7
Secondary	Stroop Victoria Test		Days 1-7
Secondary	Incompatibility Test		Days 1-7
Secondary	Flexibility test		Days 1-7
Secondary	Go-NoGo		Days 1-7
Secondary	Working memory - TEA		Days 1-7
Secondary	Mood Disorders Insight Scale		Days 1-7
Secondary	Verbal fluency test		Days 1-7
Secondary	Future autobiographical fluency task		Days 1-7
Secondary	Bristol Emotion Recognition Test		Days 1-7
Secondary	Cognitive Emotion Regulation Questionnaire		Days 1-7
Secondary	Questionnaire on negative attitudes towards problems		Days 1-7
Secondary	Revised self-awareness scale, Self-reference task		Days 1-7
Secondary	Balanced Temporal Perspective Scale		Days 1-7
Secondary	Suicide attempt within 6 months of follow-up		Month 6