Apathy in Schizophrenia

NCT ID: NCT01689181

Last Updated: 2025-01-23

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-06-30
• Study Completion Date: 2013-06-05

Brief Summary

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

Conditions

Schizophrenia; Apathy

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

chronic schizophrenic patients

No interventions assigned to this group

healthy volunteers

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Male or Female aged 20 to 55 years old included
• Under French public assurance system

• 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

• Personal history of neurological disorders
• Personal history of head injury
• Alcohol or substance abuse
• Under psychotropic drug
• Contraindication for MRI

• Schizo-affective disorder
• Personal history of neurological disorders
• Personal history of head injury
• Alcohol or substance abuse
• Contraindication for MRI

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Institut National de la Santé Et de la Recherche Médicale, France

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Richard Levy, MD

Role: PRINCIPAL_INVESTIGATOR

INSERM MEDU 945, Centre de Recherche-Institut du Cerveau et de la Moelle (CR-ICM), Hôpital de la Pitié Salpétrière, 75013 Paris

Locations

INSERM MEDU 945, Centre de Recherche-Institut du Cerveau et de la Moelle (CR-ICM), Hôpital de la Pitié Salpétrière

Paris, , France

Countries

France

Other Identifiers

2011-A01610-41

Identifier Type: REGISTRY

Identifier Source: secondary_id

C11-39

Identifier Type: -

Identifier Source: org_study_id