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Multidimensional Apathy in Psychiatric Pathologies. (AmSeD)

U

University Hospital, Strasbourg, France

Status

Enrolling

Conditions

Apathy

Treatments

Other: Cognitive tasks with EEG recording

Study type

Interventional

Funder types

Other

Identifiers

NCT04757220
8062 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment

144 estimated patients

Sex

All

Ages

18 to 60 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Other

Allocation

Non-Randomized

Interventional model

Factorial Assignment

Masking

None (Open label)

144 participants in 3 patient groups

Patients with schizophrenia
Experimental group
Description:
* 5 subjective questionnaires * 4 cognitive tasks with EEG recordings
Treatment:
Other: Cognitive tasks with EEG recording
Patients with depression
Experimental group
Description:
* 5 subjective questionnaires * 4 cognitive tasks with EEG recordings
Treatment:
Other: Cognitive tasks with EEG recording
Healthy controls
Active Comparator group
Description:
* 5 subjective questionnaires * 4 cognitive tasks with EEG recordings
Treatment:
Other: Cognitive tasks with EEG recording

Trial contacts and locations

1

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Central trial contact

Anne Bonnefond, PHD; Fabrice Berna, MD

Data sourced from clinicaltrials.gov

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