Multiple SclerosisSepDepNCT02468765
Depression and Facial Identity Recognition Abilities in Patients With Multiple Sclerosis
An observational study of Multiple Sclerosis and Depression, run by Lille Catholic University at 1 site in France.
Trial summary
Cognitive and emotional disorders are often encountered in multiple sclerosis (MS) cases: depressive and bipolar disorders are twice as frequent as in general population. Cognitive disorders, (particularly attention and dysexecutive disorders), appear in early stages of the disease's evolution, in cases of lightly or… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Multiple Sclerosis, Depression
- What is being tested?
- Neuropsychological and emotional evaluation with monitoring
- How many people
- 38 participants
- Where
- 1 siteFrance
- Study dates
- 24 Apr 2015to 30 May 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Three groups will participate: Depressive MS patients, non depressive MS patients and a control group
Who may be able to join
- Man or Woman between 18 and 65 years old
- Participant understanding and able to speak French
- Participant understanding the Participant Informed Sheet and who has signed the Informed Consent
- Participant with Health Insurance
- MS Patients :
- Patient with relapsing remitting multiple sclerosis form
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- Expanded Disability Status Scale (EDSS) < 4
- Patient without motor disorders, cerebellar or significant upper limb somatosensory or visual disturbances
- Control Participants :
- Participant without global cognitive deterioration
Who cannot join
- Participant taking part of other biomedical studies involving drug tests
- Participant with other neurological pathologies, head trauma with loss of consciousness, psychiatric pathologies, serious general affections, alcoholism, perception disorders, dysarthria, disorders preventing oral communication and reading, under prescription of psychotropic drugs
- Mental or visual incapacity to take part in the study
- Participant with antecedents of drug or alcohol abuse
- Allergy to the components of the gel used during the EEG
- Patients with MRI contraindications : Pacemaker or neurostimulator or Implantable Cardioverter Defibrillator (ICD), Cochlear Implants, ocular or cerebral ferromagnetic foreign body close to the nerve structures, metal prostheses,
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- Uncooperative or agitated patients,
- Claustrophobic patients,
- Ventricular peritoneal shunts and neurosurgical valves,
- Braces
- MS patient without MRI in the last 4 months
- Adults under guardianship, under judicial protection, persons deprived of liberty,
- Pregnant or breast feeding women,
- MS patient with another MS form than Relapsing-Remitting,
- MS patient who encountered a relapse in the last 6 weeks,
- MS patient treated with corticoids in the last month.
Trial locations and contacts
1 site in 1 country.
France1 site
Hôpital Saint Vincent de Paul (GHICL)
Lille, Hauts-de-France, 59000
About this study
Official title: Depression and Reconnaissance of Emotions in Multiple Sclerosis Patients
Cognitive and emotional disorders are often encountered in multiple sclerosis (MS) cases: depressive and bipolar disorders are twice as frequent as in general population.
Cognitive disorders, (particularly attention and dysexecutive disorders), appear in early stages of the disease's evolution, in cases of lightly or moderately disabled patients, with a recent evolution, with a "minor" form of the disease, even in Clinically Isolated Syndromes (CIS). Emotional disturbances are essentially linked to mood disorders of depression-type.
Read more
Last ten years, emotional processing in multiple sclerosis cases was investigated in various trials, especially regarding the recognition of facial and emotional expressions. These studies reported data, supporting an impairment of the perception of emotion, particularly those with negative valence.
The objective of this study is to investigate the link between recognition of facial and emotional expressions and depression in multiple sclerosis cases.
Read the detailed description
Cognitive and emotional disorders in MS are common. Cognitive impairments, mainly attentional and dysexecutive, appear early in the course of the disease, in patients with mild to moderate disability, a very recent duration of evolution, a so-called "benign" form, and even in clinically isolated syndromes (CIS). Emotional disturbances mainly concern mood disorders, such as depression. Thus, Figved et al (2005) found neuropsychiatric disorders, often combined, in about 80% of their patients at the beginning of the course, with depression (59%), irritability/emotional stability (42%) and apathy (31%) being the most common. More specifically, depressive syndromes and bipolar disorders are found in MS with twice the frequency of the general population. Over the last ten years, the treatment of emotions in MS has been the subject of a few studies. MS has been the subject of several studies, notably concerning the recognition of emotional facial expressions (EFEs). Several studies have reported data in favor of an impairment of the perception of emotion perception of emotion, particularly with negative valence. These difficulties in emotion perception appear to be associated with cognitive difficulties, such as slowed processing speed and dysexecutive difficulties. This deficit appears early in the course of the disease.
Moreover, although this deficit has been little studied, such a disorder could lead to difficulties in maintaining social interaction. These patients showed a deficit in learning and recognition of non-verbal social non-verbal social cues and emotional components, independently of the cognitive impairment but more marked in the case of a functional impairment and a longer duration of the disease.
Finally, there seems to be specific relationships between problems of of emotion and poor quality of life. Indeed, the levels of certain social and psychological aspects of quality of life in MS have been correlated with these emotion perception scores, highlighting the importance of considering these emotional emotional skills in assessing the impact of MS on the patient. on the patient. The correct analysis of EFEs is a complex mental process process, requiring the functional integrity of a number of cognitive domains (working memory, attention, visual-spatial perception and executive and executive functions). In view of the impact of depression on the analytical capacities of the EFEs, described in numerous studies, the high prevalence of and alexithymia in MS patients allows us to consider these two dimensions as to consider these two dimensions as factors that may influence their identification of EFEs.
Concerning alexithymia, one study has already observed its impact on the deficit of recognition of EFEs, but no study has investigated the link between depression and such a deficiency. However, the identification of a link between the recognition abilities of EFEs and these psycho-affective disturbances would allow the development of rehabilitative treatments aiming to limit the impact of the emotional fragility of patients in their daily life and, consequently, to improve their quality of life.
- Conditions
- Multiple Sclerosis, Depression
- Being tested
- Neuropsychological and emotional evaluation with monitoring
- Medical subject headings
- Multiple Sclerosis, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuropsychological and emotional evaluation with monitoringOther
Recognition tasks of emotional facial expressions with electroencephalogram, electrodermal activity measure and heart rate measure, questionnaires and neuropsychological tests
| Study group | Role | What they receive |
|---|---|---|
| Depressive MS patients | Neuropsychological and emotional evaluation with monitoring Receives: Other: Neuropsychological and emotional evaluation with monitoring | |
| Non depressive MS patients | Neuropsychological and emotional evaluation with monitoring Receives: Other: Neuropsychological and emotional evaluation with monitoring | |
| Control | Neuropsychological and emotional evaluation with monitoring Receives: Other: Neuropsychological and emotional evaluation with monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of correct answers to recognition tasks of emotional facial expressions (categorization by anger, joy or neutral)
Rates of correct responses to the different questions of the EFEs recognition test (categorization of emotional expression (anger, joy, or neutral), assessment of the intensity of the emotion, and the degree of certainty of the responses given), compared between the three groups of participants.
Measured: first day of enrollement
Secondary outcomes (3)
Correlation between facial identity recognition abilities and physiological index measured by electroencephalography
Measured: first day of enrollement
Correlation between facial identity recognition abilities and morphological index measured by magnetic resonance imaging
Measured: first day of enrollement
Correlation between facial identity recognition abilities and cognitive functions evaluated by different tests
Correlation between facial identity recognition abilities and cognitive functions evaluated by different tests (BCcogSEP) et questionnaires (TAS 20, FIS, STAI Y et BDI II).
Measured: first day of enrollement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2015 (estimated)
- Study start24 Apr 2015
- Primary completion30 May 2016
- Study completion30 May 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lille Catholic University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Patrick Hautecoeur, MD, Principal investigator, Groupment des Hôpitaux de l'Institut Catholique de Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02468765
- Sponsor's protocol ID
- RC-P0040
- Acronym
- SepDep
- Status last verified
- Sep 2025
- First submitted
- 9 Jun 2015
- Last updated
- 4 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Depression and Reconnaissance of Emotions in Multiple Sclerosis Patients
- ClinicalTrials.gov ID
- NCT02468765
- Acronym / sponsor ID
- SepDep / RC-P0040
- Conditions
- Multiple Sclerosis, Depression
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Lille Catholic UniversityUniversity, hospital or other
- Study start
- 24 Apr 2015 (actual)
- Primary completion
- 30 May 2016 (actual)
- Study completion
- 30 May 2016 (actual)
- First posted
- 11 Jun 2015 (estimated)
- 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.
Cognitive and emotional disorders are often encountered in multiple sclerosis (MS) cases: depressive and bipolar disorders are twice as frequent as in general population.
Cognitive disorders, (particularly attention and dysexecutive disorders), appear in early stages of the disease's evolution, in cases of lightly or moderately disabled patients, with a recent evolution, with a "minor" form of the disease, even in Clinically Isolated Syndromes (CIS). Emotional disturbances are essentially linked to mood disorders of depression-type.
Last ten years, emotional processing in multiple sclerosis cases was investigated in various trials, especially regarding the recognition of facial and emotional expressions. These studies reported data, supporting an impairment of the perception of emotion, particularly those with negative valence.
The objective of this study is to investigate the link between recognition of facial and emotional expressions and depression in multiple sclerosis cases.
Detailed description
Cognitive and emotional disorders in MS are common. Cognitive impairments, mainly attentional and dysexecutive, appear early in the course of the disease, in patients with mild to moderate disability, a very recent duration of evolution, a so-called "benign" form, and even in clinically isolated syndromes (CIS). Emotional disturbances mainly concern mood disorders, such as depression. Thus, Figved et al (2005) found neuropsychiatric disorders, often combined, in about 80% of their patients at the beginning of the course, with depression (59%), irritability/emotional stability (42%) and apathy (31%) being the most common. More specifically, depressive syndromes and bipolar disorders are found in MS with twice the frequency of the general population. Over the last ten years, the treatment of emotions in MS has been the subject of a few studies. MS has been the subject of several studies, notably concerning the recognition of emotional facial expressions (EFEs). Several studies have reported data in favor of an impairment of the perception of emotion perception of emotion, particularly with negative valence. These difficulties in emotion perception appear to be associated with cognitive difficulties, such as slowed processing speed and dysexecutive difficulties. This deficit appears early in the course of the disease.
Moreover, although this deficit has been little studied, such a disorder could lead to difficulties in maintaining social interaction. These patients showed a deficit in learning and recognition of non-verbal social non-verbal social cues and emotional components, independently of the cognitive impairment but more marked in the case of a functional impairment and a longer duration of the disease.
Finally, there seems to be specific relationships between problems of of emotion and poor quality of life. Indeed, the levels of certain social and psychological aspects of quality of life in MS have been correlated with these emotion perception scores, highlighting the importance of considering these emotional emotional skills in assessing the impact of MS on the patient. on the patient. The correct analysis of EFEs is a complex mental process process, requiring the functional integrity of a number of cognitive domains (working memory, attention, visual-spatial perception and executive and executive functions). In view of the impact of depression on the analytical capacities of the EFEs, described in numerous studies, the high prevalence of and alexithymia in MS patients allows us to consider these two dimensions as to consider these two dimensions as factors that may influence their identification of EFEs.
Concerning alexithymia, one study has already observed its impact on the deficit of recognition of EFEs, but no study has investigated the link between depression and such a deficiency. However, the identification of a link between the recognition abilities of EFEs and these psycho-affective disturbances would allow the development of rehabilitative treatments aiming to limit the impact of the emotional fragility of patients in their daily life and, consequently, to improve their quality of life.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Depressive MS patients | – | Other: Neuropsychological and emotional evaluation with monitoringNeuropsychological and emotional evaluation with monitoring |
| Non depressive MS patients | – | Other: Neuropsychological and emotional evaluation with monitoringNeuropsychological and emotional evaluation with monitoring |
| Control | – | Other: Neuropsychological and emotional evaluation with monitoringNeuropsychological and emotional evaluation with monitoring |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Three groups will participate: Depressive MS patients, non depressive MS patients and a control group
Key inclusion criteria (10 listed)
- Man or Woman between 18 and 65 years old
- Participant understanding and able to speak French
- Participant understanding the Participant Informed Sheet and who has signed the Informed Consent
- Participant with Health Insurance
- Patient with relapsing remitting multiple sclerosis form
Key exclusion criteria (16 listed)
- Participant taking part of other biomedical studies involving drug tests
- Participant with other neurological pathologies, head trauma with loss of consciousness, psychiatric pathologies, serious general affections, alcoholism, perception disorders, dysarthria, disorders preventing oral communication and reading, under prescription of psychotropic drugs
- Mental or visual incapacity to take part in the study
- Participant with antecedents of drug or alcohol abuse
- Allergy to the components of the gel used during the EEG
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 |
|---|---|---|
| Neuropsychological and emotional evaluation with monitoringRecognition tasks of emotional facial expressions with electroencephalogram, electrodermal activity measure and heart rate measure, questionnaires and neuropsychological tests | Other | Control, Depressive MS patients, Non depressive MS patients |
Primary outcome
Rate of correct answers to recognition tasks of emotional facial expressions (categorization by anger, joy or neutral)
Time frame: first day of enrollement
Rates of correct responses to the different questions of the EFEs recognition test (categorization of emotional expression (anger, joy, or neutral), assessment of the intensity of the emotion, and the degree of certainty of the responses given), compared between the three groups of participants.
3 secondary outcomes
Correlation between facial identity recognition abilities and physiological index measured by electroencephalography
Time frame: first day of enrollement
Correlation between facial identity recognition abilities and morphological index measured by magnetic resonance imaging
Time frame: first day of enrollement
Correlation between facial identity recognition abilities and cognitive functions evaluated by different tests
Time frame: first day of enrollement
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2025.
- 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. This study is not recruiting at the moment.
Patrick Hautecoeur, MD principal investigator
Groupment des Hôpitaux de l'Institut Catholique de Lille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis and Depression, run by Lille Catholic University 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 10 inclusion and 16 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: finished, as of the sponsor's last update on 4 Sep 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of correct answers to recognition tasks of emotional facial expressions (categorization by anger, joy or neutral) (time frame: first day of enrollement). 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 4 Sep 2025.