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NCT Number: NCT04757220

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.

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Key information

Conditions

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

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Service de Psychiatrie, Hôpital Civil, Hôpitaux Universitaires de Strasbourg

Strasbourg, 67091, France

Location status: Recruiting

Location contact

Anne BONNEFOND, MD

SUB_INVESTIGATOR

Anne GIERSCH, MD

SUB_INVESTIGATOR

Fabrice BERNA, MD

CONTACT

[email protected]

33.3.88.11.64.62

Fabrice BERNA, MD

PRINCIPAL_INVESTIGATOR

Gilles BERTSCHY, MD

SUB_INVESTIGATOR

Jack FOUCHER, MD

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cognitive tasks with EEG recording

Other

questionnaires and cognitives tasks

Primary outcomes

  1. Assessment of the motivational form of apathy

    Time frame: first baseline visit

    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.

  2. Assessment of the cognitive form of apathy

    Time frame: first baseline visit

    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.

  3. Assessment of the behavioural form of apathy

    Time frame: first baseline visit

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Anne Bonnefond, PHD

CONTACT

[email protected]

00333 ext. 88116132

Fabrice Berna, MD

CONTACT

[email protected]

00333 ext. 88116132

Sponsors and collaborators

Lead sponsor

University Hospital, Strasbourg, France

Other

Registry information

Official study title

Cognitive and Neural Mechanisms of Multidimensional Apathy in Psychiatric Pathologies

Acronym: AmSeD

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
Feb 17, 2021
Registry last updated
Aug 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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