- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning 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
Studieöversikt
Status
Betingelser
Studietyp
Inskrivning (Förväntat)
Kontakter och platser
Studieorter
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Paris, Frankrike, 75013
- Rekrytering
- INSERM MEDU 945, Centre de Recherche-Institut du Cerveau et de la Moelle (CR-ICM), Hôpital de la Pitié Salpétrière
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
schizophrenic patients:
- outpatients of the Corentin Celton psychiatric service
- inpatients of the Corentin Celton Day Hospital Unit
healthy volunteers: community
Beskrivning
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
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
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friska frivilliga
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chronic schizophrenic patients
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
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apathy as measured by Starkstein's Apathy Evaluation Scale
Tidsram: baseline
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baseline
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
neuropsychological performance
Tidsram: baseline
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baseline
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clinical assessment (for patients only)
Tidsram: 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
Tidsram: baseline
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voxel based morphometry
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baseline
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Samarbetspartners och utredare
Utredare
- Huvudutredare: 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
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Förväntat)
Avslutad studie (Förväntat)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- C11-39
- 2011-A01610-41 (Registeridentifierare: IDRCB)
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