- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02737540
Neuropsychological Factors Associated With Vulnerability to Suicidal Behavior in Depressed Elderly Patients (SPAD)
연구 개요
상태
정황
상세 설명
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.
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
-
-
-
Nîmes, 프랑스, 30000
- Clinique Les Sophoras
-
Nîmes Cedex 09, 프랑스, 30029
- CHRU de Nîmes - Hôpital Universitaire Carémeau
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
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).
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
---|
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.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
---|---|
Trust Game
기간: Days 1-7
|
Days 1-7
|
Ultimatum Game
기간: Days 1-7
|
Days 1-7
|
Iowa Gambling Task
기간: Days 1-7
|
Days 1-7
|
2차 결과 측정
결과 측정 |
기간 |
---|---|
Stroop Victoria Test
기간: Days 1-7
|
Days 1-7
|
Incompatibility Test
기간: Days 1-7
|
Days 1-7
|
Flexibility test
기간: Days 1-7
|
Days 1-7
|
Go-NoGo
기간: Days 1-7
|
Days 1-7
|
Working memory - TEA
기간: Days 1-7
|
Days 1-7
|
Mood Disorders Insight Scale
기간: Days 1-7
|
Days 1-7
|
Verbal fluency test
기간: Days 1-7
|
Days 1-7
|
Future autobiographical fluency task
기간: Days 1-7
|
Days 1-7
|
Bristol Emotion Recognition Test
기간: Days 1-7
|
Days 1-7
|
Cognitive Emotion Regulation Questionnaire
기간: Days 1-7
|
Days 1-7
|
Questionnaire on negative attitudes towards problems
기간: Days 1-7
|
Days 1-7
|
Revised self-awareness scale, Self-reference task
기간: Days 1-7
|
Days 1-7
|
Balanced Temporal Perspective Scale
기간: Days 1-7
|
Days 1-7
|
Suicide attempt within 6 months of follow-up
기간: Month 6
|
Month 6
|
공동 작업자 및 조사자
수사관
- 연구 책임자: Fabrice JOLLANT, MD, Centre Hospitalier Universitaire De Nimes
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .