ApathyAmSeDNCT04757220
Multidimensional Apathy in Psychiatric Pathologies.
A study testing Cognitive tasks with EEG recording in people with Apathy, run by University Hospital, Strasbourg, France at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Apathy
- What is being tested?
- Cognitive tasks with EEG recording
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 1 siteFrance
- Study dates
- 5 Jan 2022to 1 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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)
Who cannot join
- 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)
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- persons in an emergency situation
- persons deprived in any way of their liberty
- persons in period of exclusion in an other protocol
- use of psychotropic substance during the 3 weeks before the study
- use of benzodiazepines
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Service de Psychiatrie, Hôpital Civil, Hôpitaux Universitaires de Strasbourg
Strasbourg, 67091
Fabrice BERNA, MD, 33.3.88.11.64.62, fabrice.berna@chru-strasbourg.fr
Fabrice BERNA, MD
About this study
Official title: Cognitive and Neural Mechanisms of 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.
- Conditions
- Apathy
- Being tested
- Cognitive tasks with EEG recording
- Medical subject headings
- Lethargy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive tasks with EEG recordingOther
questionnaires and cognitives tasks
| Study group | Role | What they receive |
|---|---|---|
| Patients with schizophrenia | Experimental | * 5 subjective questionnaires
* 4 cognitive tasks with EEG recordings Receives: Other: Cognitive tasks with EEG recording |
| Patients with depression | Experimental | * 5 subjective questionnaires
* 4 cognitive tasks with EEG recordings Receives: Other: Cognitive tasks with EEG recording |
| Healthy controls | Active comparator | * 5 subjective questionnaires
* 4 cognitive tasks with EEG recordings Receives: Other: Cognitive tasks with EEG recording |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: first baseline visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2021
- Study start5 Jan 2022
- Primary completion1 Mar 2027 (estimated)
- Study completion1 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ApathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 144 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04757220
- Sponsor's protocol ID
- 8062
- Acronym
- AmSeD
- Status last verified
- Aug 2026
- First submitted
- 12 Jan 2021
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive and Neural Mechanisms of Multidimensional Apathy in Psychiatric Pathologies
- ClinicalTrials.gov ID
- NCT04757220
- Acronym / sponsor ID
- AmSeD / 8062
- Conditions
- Apathy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 144 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 5 Jan 2022 (actual)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 17 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patients with schizophrenia | Experimental | Other: Cognitive tasks with EEG recording* 5 subjective questionnaires * 4 cognitive tasks with EEG recordings |
| Patients with depression | Experimental | Other: Cognitive tasks with EEG recording* 5 subjective questionnaires * 4 cognitive tasks with EEG recordings |
| Healthy controls | Active comparator | Other: Cognitive tasks with EEG recording* 5 subjective questionnaires * 4 cognitive tasks with EEG recordings |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive tasks with EEG recordingquestionnaires and cognitives tasks | Other | Healthy controls, Patients with depression, Patients with schizophrenia |
Primary outcome
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.
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive tasks with EEG recording in people with Apathy, run by University Hospital, Strasbourg, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fabrice Berna, MD (00333 ext. 88116132, fabrice.berna@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of the motivational form of apathy (time frame: first baseline visit). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2026; AzTrials last refreshed its copy on 27 Oct 2026.