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Recruiting NCT04757220

Multidimensional Apathy in Psychiatric Pathologies.

No phase Interventional Apathy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Cognitive tasks with EEG recording.
Who it may be relevant to
Registry conditions: Apathy. Basic parameters: 18 years — 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Cognitive and Neural Mechanisms of Multidimensional Apathy in Psychiatric Pathologies

Overview

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.

Interventions

  • Other Cognitive tasks with EEG recording
    questionnaires and cognitives tasks

Primary outcome measures

  • Assessment of the motivational form of apathy [Time frame: first baseline visit]
  • Assessment of the cognitive form of apathy [Time frame: first baseline visit]
  • Assessment of the behavioural form of apathy [Time frame: first baseline visit]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Non-randomized
Model
Factorial
Masking
Open label
Primary purpose
Other

Study locations

France · 1 center
  • Service de Psychiatrie, Hôpital Civil, Hôpitaux Universitaires de Strasbourg — Strasbourg

Identifiers

NCT: NCT04757220 · 8062

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗