Clinical trial NCT04757220: Multidimensional Apathy in Psychiatric Pathologies.
Official title: Cognitive and Neural Mechanisms of Multidimensional Apathy in Psychiatric Pathologies
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Apathy
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2021-02-17
Enrollment: 144
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: OTHER

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.


Eligibility criteria: 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

Primary outcomes:
measure: Assessment of the motivational form of apathy
timeFrame: first baseline visit
measure: Assessment of the cognitive form of apathy
timeFrame: first baseline visit
measure: Assessment of the behavioural form of apathy
timeFrame: first baseline visit
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service de Psychiatrie, Hôpital Civil, Hôpitaux Universitaires de Strasbourg
Study officials:
References: