- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Paris, France, 75013
- INSERM MEDU 945, Centre de Recherche-Institut du Cerveau et de la Moelle (CR-ICM), Hôpital de la Pitié Salpétrière
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
schizophrenic patients:
- outpatients of the Corentin Celton psychiatric service
- inpatients of the Corentin Celton Day Hospital Unit
healthy volunteers: community
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
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healthy volunteers
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chronic schizophrenic patients
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
apathy as measured by Starkstein's Apathy Evaluation Scale
Time Frame: baseline
|
baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
neuropsychological performance
Time Frame: baseline
|
|
baseline
|
|
clinical assessment (for patients only)
Time Frame: baseline
|
scores on evaluation scales (PANSS, SAPS, SANS, CDS, SDS)
|
baseline
|
|
volumetric brain abnormalities
Time Frame: baseline
|
voxel based morphometry
|
baseline
|
Collaborators and Investigators
Investigators
- Principal Investigator: 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
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- C11-39
- 2011-A01610-41 (Registry Identifier: IDRCB)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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