Skip to main content
OpenTrials
Completed

NCT Number: NCT01689181

Apathy in Schizophrenia

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

Completed

Looking for future studies?

Notify Me

Key information

Age range

20 year–55 year

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Paris, 75013, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. apathy as measured by Starkstein's Apathy Evaluation Scale

    Time frame: baseline

Secondary outcomes

  1. neuropsychological performance

    Time frame: baseline

    • 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)
  2. clinical assessment (for patients only)

    Time frame: baseline

    scores on evaluation scales (PANSS, SAPS, SANS, CDS, SDS)

  3. volumetric brain abnormalities

    Time frame: baseline

    voxel based morphometry

Sponsors and collaborators

Lead sponsor

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

Other Gov

Registry information

Official study title

L'apathie Dans La Schizophrénie: Étude Neuropsychologique Et Anatomique

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Sep 21, 2012
Registry last updated
Jan 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.