- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02901769
Emotional Prosody Recognition and Decision Making Inf fMRI and Vulnerability to Suicide (EMODES)
Suicide is known to be frequent in depression, and in most of the psychiatric diseases. But as it can occur in patients with no psychiatric illness and doesn't occur in every patients with psychiatric illness, it has to be considered henceforth as a specific vulnerability.
This trial will study two fMRI paradigms, emotional prosody recognition and decision making, in order to characterize emotional and cognitive trait factors in a population of patients vulnerable to suicide. Four different groups will be constituted : depressed suicide attempters, depressed patients with past history of suicidal acts, depressed patients with no history of suicidal acts and healthy controls.
The main goal will be to correlate fMRI activation during the two paradigms in subjects vulnerable to suicide. The secondary goals will be to characterize emotional and cognitive trait factors in these subjects, to demonstrate that those characteristics are independent from depression and to correlate these trait factors with socio-demographic and clinical features with fMRI activations.
Studieoversigt
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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-
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Rennes, Frankrig, 35000
- Rennes University Hospital
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Beskrivelse
Inclusion Criteria:
- Right-handed,
- Depressed suicide attempters for the first group,
- Depressed patients with past history of suicidal acts for the second group,
- Depressed patients with no history of suicidal acts for the third group,
- Healthy controls for the fourth group.
Exclusion Criteria:
- Another psychiatric trouble than depression,
- Another psychotrope treatment than SSRI/SNRI and/or benzodiazepine at inclusion and/or one month before,
- For the first and secand groups : more than fous suicidals acts within the past 3 years,
- Deficits that do not allow test realisation (visual audition troubles, cognitif deficits,
- Prosopagnosia,
- Pregnancy,
- Severe central nervous system disease or somatic disease,
- MRI contra-indication,
- Major benefiting from a legal protective measure,
- No coverage care.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Andet
- Tildeling: Ikke-randomiseret
- Interventionel model: Enkelt gruppeopgave
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: Depressed suicide attempters
20 subjects
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two fMRI paradigms, emotional prosody recognition and decision making
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Eksperimentel: Depressed patients with past history of
20 subjects
|
two fMRI paradigms, emotional prosody recognition and decision making
|
|
Eksperimentel: Depressed patients with no history of
20 subjects
|
two fMRI paradigms, emotional prosody recognition and decision making
|
|
Placebo komparator: Healthy controls
20 subjects
|
two fMRI paradigms, emotional prosody recognition and decision making
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
fMRI activation area
Tidsramme: 1 day
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1 day
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Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Anslået)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 2011-A00944-37
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