- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01689181
Apathy in Schizophrenia
L'Apathie Dans la schizophrénie: étude Neuropsychologique et Anatomique
Apathy, defined as a quantitative reduction of voluntary, goal-directed behaviours (GDB), is a core component of negative symptoms. It has been suggested that the physiopathology of apathy is not a single entity but may be multiple, depending on which specific process or macrofunction is disrupted during completion of GDB. In line with this notion, Levy and Dubois proposed dividing apathic syndromes into three subtypes of disrupted processing: 'a-motivation', 'cognitive inertia', and 'uncoupling'. In schizophrenia, apathy has been associated with executive dysfunction, functional impairment and poor outcome. However, the neurobiological underpinnings of apathy in schizophrenia are poorly understood.
Primary objective: confirm that chronic schizophrenic patients are apathic compared to healthy volunteers
Secondary objectives:
- investigate if apathy is related to a particular aspect of the disease (i.e. negative, positive symptomatology and/or deficit form)
- investigate if apathy correlates with executive dysfunction
- investigate if apathy is associated with a specific mechanism using an experimental task specially designed to investigate the different mechanism (i.e. 'a-motivation', 'cognitive inertia', and 'uncoupling')
- investigate if there is a volumetric abnormality affecting the executive system in apathic schizophrenic patients
- link these eventual volumetric abnormalities to prefrontal cortex-basal ganglia circuits according to a specific subtype of apathy in the apathic schizophrenic group
Studieoversigt
Status
Betingelser
Undersøgelsestype
Tilmelding (Forventet)
Kontakter og lokationer
Studiesteder
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Paris, Frankrig, 75013
- Rekruttering
- INSERM MEDU 945, Centre de Recherche-Institut du Cerveau et de la Moelle (CR-ICM), Hôpital de la Pitié Salpétrière
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
schizophrenic patients:
- outpatients of the Corentin Celton psychiatric service
- inpatients of the Corentin Celton Day Hospital Unit
healthy volunteers: community
Beskrivelse
Inclusion Criteria (healthy volunteers):
- Male or Female aged 20 to 55 years old included
- Under French public assurance system
Exclusion Criteria (healthy volunteers):
- Personal history of neurological disorders
- Personal history of head injury
- Alcohol or substance abuse
- Under psychotropic drug
- Contraindication for MRI
Inclusion Criteria (schizophrenic patients):
- Male or Female aged 20 to 55 years old included
- Under French public assurance system
- diagnosis of schizophrenia according to the DSM-IV R criteria
- Duration of illness > 5 years
- clinical stability during the past 2 months (defined as no treatment modification or hospitalisation 2 months prior evaluation)
Exclusion Criteria (schizophrenic patients):
- Schizo-affective disorder
- Personal history of neurological disorders
- Personal history of head injury
- Alcohol or substance abuse
- Contraindication for MRI
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
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sunde frivillige
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chronic schizophrenic patients
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
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apathy as measured by Starkstein's Apathy Evaluation Scale
Tidsramme: baseline
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baseline
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
neuropsychological performance
Tidsramme: baseline
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baseline
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clinical assessment (for patients only)
Tidsramme: baseline
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scores on evaluation scales (PANSS, SAPS, SANS, CDS, SDS)
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baseline
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volumetric brain abnormalities
Tidsramme: baseline
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voxel based morphometry
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baseline
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Samarbejdspartnere og efterforskere
Efterforskere
- Ledende efterforsker: Richard Levy, MD, INSERM MEDU 945, Centre de Recherche-Institut du Cerveau et de la Moelle (CR-ICM), Hôpital de la Pitié Salpétrière, 75013 Paris
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Forventet)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- C11-39
- 2011-A01610-41 (Registry Identifier: IDRCB)
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