Multidimensional Apathy in Psychiatric Pathologies.

NCT04757220 | Recruiting

• 1 other identifier: 8062
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 1

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.

Conditions

Apathy

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (3)

Patients with schizophrenia

EXPERIMENTAL

* 5 subjective questionnaires * 4 cognitive tasks with EEG recordings

Other: Cognitive tasks with EEG recording

Patients with depression

EXPERIMENTAL

* 5 subjective questionnaires * 4 cognitive tasks with EEG recordings

Other: Cognitive tasks with EEG recording

Healthy controls

ACTIVE COMPARATOR

* 5 subjective questionnaires * 4 cognitive tasks with EEG recordings

Other: Cognitive tasks with EEG recording

Interventions

Cognitive tasks with EEG recording OTHER

questionnaires and cognitives tasks

Healthy controls; Patients with depression; Patients with schizophrenia

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• \- presence of DSM-V TR criteria for schizophrenia (American Psychiatric Association, 1994)
• \- presence of DSM-V TR criteria for depression (American Psychiatric Association, 1994)

You may not qualify if:

• 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
• \- use of psychotropic substance during the 3 weeks before the study
• \- use of benzodiazepines

Sponsors & Collaborators

• University Hospital, Strasbourg, France: lead

Study Sites (1)

Service de Psychiatrie, Hôpital Civil, Hôpitaux Universitaires de Strasbourg

Strasbourg, 67091, France

RECRUITING

MeSH Terms

Conditions

Lethargy

Condition Hierarchy (Ancestors)

Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Fabrice Berna, MD

CONTACT

00333; fabrice.berna@chru-strasbourg.fr

Anne Bonnefond, PHD

CONTACT

00333; anne.bonnefond@unistra.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 12, 2021
• First Posted: February 17, 2021
• Study Start: January 5, 2022
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: August 3, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)