Multidimensional Apathy in Psychiatric Pathologies. (AmSeD)

Cognitive and Neural Mechanisms of Multidimensional Apathy in Psychiatric Pathologies

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.

Study Overview

• Status: Recruiting
• Conditions: Apathy
• Intervention / Treatment: Other: Cognitive tasks with EEG recording

• Study Type: Interventional
• Enrollment (Estimated): 144
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Fabrice Berna, MD; Phone Number: 88116132 00333; Email: fabrice.berna@chru-strasbourg.fr
• Study Contact Backup: Name: Anne Bonnefond, PHD; Phone Number: 88116132 00333; Email: anne.bonnefond@unistra.fr

Study Locations

• France
  • Strasbourg, France, 67091
    • Recruiting
    • Service de Psychiatrie, Hôpital Civil, Hôpitaux Universitaires de Strasbourg
    • Sub-Investigator: Jack FOUCHER, MD
    • Sub-Investigator: Anne GIERSCH, MD
    • Principal Investigator: Fabrice BERNA, MD
    • Contact: Fabrice BERNA, MD; Phone Number: 33.3.88.11.64.62; Email: fabrice.berna@chru-strasbourg.fr
    • Sub-Investigator: Gilles BERTSCHY, MD
    • Sub-Investigator: Anne BONNEFOND, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Factorial Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of the motivational form of apathy	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.	first baseline visit
Assessment of the cognitive form of apathy	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.	first baseline visit
Assessment of the behavioural form of apathy	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.	first baseline visit

Collaborators and Investigators

• Sponsor: University Hospital, Strasbourg, France

Study record dates

Study Major Dates

• Study Start (Actual): January 5, 2022
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027

Study Registration Dates

• First Submitted: January 12, 2021
• First Submitted That Met QC Criteria: February 11, 2021
• First Posted (Actual): February 17, 2021

Study Record Updates

• Last Update Posted (Actual): August 3, 2025
• Last Update Submitted That Met QC Criteria: August 1, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: 8062 (CTEP)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No