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

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ClinicalTrials.gov Identifier: NCT02737540
Recruitment Status : Recruiting
First Posted : April 14, 2016
Last Update Posted : August 6, 2019
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nīmes

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.

Condition or disease
Depressive Disorder, Major

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.


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Study Type : Observational
Estimated Enrollment : 210 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Neuropsychological Factors Associated With Vulnerability to Suicidal Behavior in Depressed Elderly Patients
Actual Study Start Date : August 16, 2017
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : April 2020

Resource links provided by the National Library of Medicine


Group/Cohort
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.



Primary Outcome Measures :
  1. Trust Game [ Time Frame: Days 1-7 ]
  2. Ultimatum Game [ Time Frame: Days 1-7 ]
  3. Iowa Gambling Task [ Time Frame: Days 1-7 ]

Secondary Outcome Measures :
  1. Stroop Victoria Test [ Time Frame: Days 1-7 ]
  2. Incompatibility Test [ Time Frame: Days 1-7 ]
  3. Flexibility test [ Time Frame: Days 1-7 ]
  4. Go-NoGo [ Time Frame: Days 1-7 ]
  5. Working memory - TEA [ Time Frame: Days 1-7 ]
  6. Mood Disorders Insight Scale [ Time Frame: Days 1-7 ]
  7. Verbal fluency test [ Time Frame: Days 1-7 ]
  8. Future autobiographical fluency task [ Time Frame: Days 1-7 ]
  9. Bristol Emotion Recognition Test [ Time Frame: Days 1-7 ]
  10. Cognitive Emotion Regulation Questionnaire [ Time Frame: Days 1-7 ]
  11. Questionnaire on negative attitudes towards problems [ Time Frame: Days 1-7 ]
  12. Revised self-awareness scale, Self-reference task [ Time Frame: Days 1-7 ]
  13. Balanced Temporal Perspective Scale [ Time Frame: Days 1-7 ]
  14. Suicide attempt within 6 months of follow-up [ Time Frame: Month 6 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
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.
Criteria

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).


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02737540


Contacts
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Contact: Fabrice JOLLANT, MD +33.(0)4.66.68.34.26 fabrice.jollant@chu-nimes.fr
Contact: Carey Suehs, PhD +33.(0)4.66.68.67.88 carey.suehs@chu-nimes.fr

Locations
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France
CHRU de Nîmes - Hôpital Universitaire Carémeau Recruiting
Nîmes Cedex 09, France, 30029
Principal Investigator: Marilyn Wyart, MD         
Sub-Investigator: Fabrice Jollant, MD         
Sub-Investigator: Mocrane Abbar, MD         
Clinique Les Sophoras Not yet recruiting
Nîmes, France, 30000
Sub-Investigator: Stéphane Torres, MD         
Sub-Investigator: Guillaume Collin, MD         
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nīmes
Investigators
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Study Director: Fabrice JOLLANT, MD Centre Hospitalier Universitaire de Nîmes

Publications:
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Responsible Party: Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier: NCT02737540     History of Changes
Other Study ID Numbers: LOCAL/2016/MW-01
First Posted: April 14, 2016    Key Record Dates
Last Update Posted: August 6, 2019
Last Verified: August 2019
Additional relevant MeSH terms:
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Depressive Disorder
Depressive Disorder, Major
Mood Disorders
Mental Disorders