AmSeD: Multidimensional Apathy in Psychiatric Pathologies.

Sponsor
University Hospital, Strasbourg, France (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04757220
Collaborator
(none)
144
3
48

Study Details

Study Description

Brief Summary

Apathy is defined by quantitative decrease in goal-directed activity in comparison to the person's previous level of functioning. Apathy is a transnosographic symptom, prevalent in many neurological and psychiatric pathologies (specifically in schizophrenia and depression), and almost half of patients suffer from it. It is an important source of burden, affecting both personal and occupational life. Despite its high prevalence and negative consequences, no pharmacological or non-pharmacological treatments exist, the underlying mechanisms of apathy being poorly understood. The main aim of the present study is to advance in our knowledge of cognitive and neural mechanisms of apathy by using a multidimensional model of apathy, distinguishing three forms: executive, emotional and auto-activation/initiative.

the investigators hypothesize, independently of the pathology (schizophrenia and depression), the existence of different cognitive deficits underlying each of the 3 subforms of apathy. Indeed, according to the predictions of Levy and Dubois' model (2006), executive disorders underlie the cognitive form of apathy. It may be related to lesions of the dorsolateral prefrontal cortex and the cognitive territory of the basal ganglia. Emotional apathy could be due to motivational disorder. Dysfunctions or lesions in the orbital and medial prefrontal cortex and limbic territories of the basal ganglia may underlie this. Finally, the initiative form, may be a mixed form, with both motivational and executive difficulties. Lesions or dysfunctions may affect both the cognitive and limbic territories of the basal ganglia or the anterior cingulate cortex.

Condition or Disease Intervention/Treatment Phase
  • Other: Cognitive tasks with EEG recording
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
144 participants
Allocation:
Non-Randomized
Intervention Model:
Factorial Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Cognitive and Neural Mechanisms of Multidimensional Apathy in Psychiatric Pathologies
Anticipated Study Start Date :
Mar 1, 2021
Anticipated Primary Completion Date :
Mar 1, 2025
Anticipated Study Completion Date :
Mar 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: Patients with schizophrenia

5 subjective questionnaires 4 cognitive tasks with EEG recordings

Other: Cognitive tasks with EEG recording
questionnaires and cognitives tasks

Experimental: Patients with depression

5 subjective questionnaires 4 cognitive tasks with EEG recordings

Other: Cognitive tasks with EEG recording
questionnaires and cognitives tasks

Active Comparator: Healthy controls

5 subjective questionnaires 4 cognitive tasks with EEG recordings

Other: Cognitive tasks with EEG recording
questionnaires and cognitives tasks

Outcome Measures

Primary Outcome Measures

  1. Assessment of the motivational form of apathy [first baseline visit]

    The severity of the forms of apathy (Executive, Emotive and Initiation apathy) will be measured by using The Dimensional Apathy Scale (DAS) (Radakovic and Abrahams, 2014) and the Lille Apathy Rating Scale (LARS) (Sockeel et al., 2006) Items are scored on a 4-point Likert scale based on the frequency of occurrence of the apathetic symptoms in the previous month. 3 scores will be obtained, one for each form of apathy. A high score (maximum, 24) indicates a severe form of apathy.

  2. Assessment of the cognitive form of apathy [first baseline visit]

    The severity of the forms of apathy (Executive, Emotive and Initiation apathy) will be measured by using The Dimensional Apathy Scale (DAS) (Radakovic and Abrahams, 2014) and the Lille Apathy Rating Scale (LARS) (Sockeel et al., 2006) Items are scored on a 4-point Likert scale based on the frequency of occurrence of the apathetic symptoms in the previous month. 3 scores will be obtained, one for each form of apathy. A high score (maximum, 24) indicates a severe form of apathy.

  3. Assessment of the behavioural form of apathy [first baseline visit]

    The severity of the forms of apathy (Executive, Emotive and Initiation apathy) will be measured by using The Dimensional Apathy Scale (DAS) (Radakovic and Abrahams, 2014) and the Lille Apathy Rating Scale (LARS) (Sockeel et al., 2006) Items are scored on a 4-point Likert scale based on the frequency of occurrence of the apathetic symptoms in the previous month. 3 scores will be obtained, one for each form of apathy. A high score (maximum, 24) indicates a severe form of apathy.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 60 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Inclusion criteria (all subjects):

  • age between 18 and 60 years

  • men or women volunteers, hospitalized or not

  • subject affiliated to an health insurance

  • subject having signed an informed consent

Inclusion criteria (for schizophrenic patients):
  • presence of DSM-V TR criteria for schizophrenia (American Psychiatric Association, 1994)
Inclusion criteria (for depressive patients):
  • presence of DSM-V TR criteria for depression (American Psychiatric Association, 1994)
Exclusion Criteria:
  • a major or non stabilized somatic disorder

  • medical history likely to affect cerebral anatomy or linked to an abnormality (neonatal distress, neurochirurgical intervention, neurological disorders, stroke attack)

  • any disorders involved in the use of a psycho-active substance (as defined by the DSM-IV)

  • sensory disabling impairments, and specifically visual acuity < 8

  • general anaesthesia during the 3 months before the study

  • pregnancy (declared by the subject)

  • persons in an emergency situation

  • persons deprived in any way of their liberty

  • persons in period of exclusion in an other protocol

Exclusion criteria (for controls):
  • use of psychotropic substance during the 3 weeks before the study
Exclusion criteria (for patients):
  • use of benzodiazepines

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • University Hospital, Strasbourg, France

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier:
NCT04757220
Other Study ID Numbers:
  • 8062
First Posted:
Feb 17, 2021
Last Update Posted:
Feb 17, 2021
Last Verified:
Jan 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Feb 17, 2021