- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT02737540
Neuropsychological Factors Associated With Vulnerability to Suicidal Behavior in Depressed Elderly Patients (SPAD)
Studieoversikt
Status
Forhold
Detaljert beskrivelse
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.
Studietype
Registrering (Faktiske)
Kontakter og plasseringer
Studiesteder
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Nîmes, Frankrike, 30000
- Clinique Les Sophoras
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Nîmes Cedex 09, Frankrike, 30029
- CHRU de Nîmes - Hôpital Universitaire Carémeau
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
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).
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
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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.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Trust Game
Tidsramme: Days 1-7
|
Days 1-7
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Ultimatum Game
Tidsramme: Days 1-7
|
Days 1-7
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Iowa Gambling Task
Tidsramme: Days 1-7
|
Days 1-7
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
Stroop Victoria Test
Tidsramme: Days 1-7
|
Days 1-7
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Incompatibility Test
Tidsramme: Days 1-7
|
Days 1-7
|
Flexibility test
Tidsramme: Days 1-7
|
Days 1-7
|
Go-NoGo
Tidsramme: Days 1-7
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Days 1-7
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Working memory - TEA
Tidsramme: Days 1-7
|
Days 1-7
|
Mood Disorders Insight Scale
Tidsramme: Days 1-7
|
Days 1-7
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Verbal fluency test
Tidsramme: Days 1-7
|
Days 1-7
|
Future autobiographical fluency task
Tidsramme: Days 1-7
|
Days 1-7
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Bristol Emotion Recognition Test
Tidsramme: Days 1-7
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Days 1-7
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Cognitive Emotion Regulation Questionnaire
Tidsramme: Days 1-7
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Days 1-7
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Questionnaire on negative attitudes towards problems
Tidsramme: Days 1-7
|
Days 1-7
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Revised self-awareness scale, Self-reference task
Tidsramme: Days 1-7
|
Days 1-7
|
Balanced Temporal Perspective Scale
Tidsramme: Days 1-7
|
Days 1-7
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Suicide attempt within 6 months of follow-up
Tidsramme: Month 6
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Month 6
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Samarbeidspartnere og etterforskere
Etterforskere
- Studieleder: Fabrice JOLLANT, MD, Centre Hospitalier Universitaire de Nīmes
Publikasjoner og nyttige lenker
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- LOCAL/2016/MW-01
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