Apathy in Schizophrenia

Schizophrenia Clinical Trial

Official title:

L'Apathie Dans la schizophrénie: étude Neuropsychologique et Anatomique

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01689181
• Other study ID #: C11-39
• Secondary ID: 2011-A01610-41
• Status: Recruiting
• Phase: N/A
• First received: September 7, 2012
• Last updated: September 17, 2012
• Start date: June 2012
• Est. completion date: September 2013

Study information

• Verified date: September 2012
• Source: Institut National de la Santé Et de la Recherche Médicale, France
• Contact: Richard LEVY, MD/PHD
• Phone: 00.33.1.49.28.24.32
• Email: richard.levy[@]sat.aphp.fr
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: September 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 55 Years

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Apathy
• Schizophrenia

Locations

Country	Name	City	State
France	INSERM MEDU 945, Centre de Recherche-Institut du Cerveau et de la Moelle (CR-ICM), Hôpital de la Pitié Salpétrière	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Institut National de la Santé Et de la Recherche Médicale, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	apathy as measured by Starkstein's Apathy Evaluation Scale		baseline	No
Secondary	neuropsychological performance	Global mental efficience: Mill Hill B and Raven's progressive matrices 38; Executive functioning:Modified Card Sorting Test, Trail Making A and B, Stroop Test, Verbal Fluences, Frontal Assessment Battery (FAB, Dubois et al., 2000); Social and Emotional Cognition: SEA (Social and Emotional Evaluation (SEA, Funkiewiez et al., 2012); Working memory (Grober and Buschke - 16 items, digit span); Instrumental functions: Rey Osterrieth Complex figure)	baseline	No
Secondary	clinical assessment (for patients only)	scores on evaluation scales (PANSS, SAPS, SANS, CDS, SDS)	baseline	No
Secondary	volumetric brain abnormalities	voxel based morphometry	baseline	No