Social CognitionREF-BIPNCT05922956
Facial Emotion Recognition in Patients With Euthymic Bipolar Disorder I and II
A study testing Facial emotion recognition test in people with Social Cognition and Facial Emotion Recognition, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
Trial summary
The facial emotion recognition is a basic social skill for successful social interactions. Several meta-analyses and recent studies found impairments of the perception of facial emotions in patients with euthymic bipolar disorder. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Social Cognition, Facial Emotion Recognition, Facial Affect
- What is being tested?
- Facial emotion recognition test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteFrance
- Study dates
- 1 Apr 2020to 1 Jul 2023
- Phase
- Interventional
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patient group :
- Male or female patients, between 18 and 60 years old
- Diagnosis of Bipolar Disorder I or Bipolar Disorder II according to DSM-IV criteria, using the French version of the Mini-International Neuropsychiatric Interview (MINI)
- Strictly euthymic defined by Hamilton Depression Rating Scale (17 items) ≤ 5 and Young Mania Rating Scale ≤ 5 for at least two months.
- Native French speakers
- Affiliated to the French social security system
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- Giving their written informed consent
- Control group :
- Male or female control subjects, aged between 18 and 60 years old, assessed using TREF
- Native French speakers
- Giving their written informed consent
Who cannot join
- Patient group :
- History of mental retardation assessed by the French version of the National Adult Reading Test
- Neurological illness or any clinical condition that could affect cognitive performance (history of head injury with loss of consciousness lasting more than 5 minutes multiple sclerosis, stroke etc.)
- Electroconvulsive therapy within the last 6 months
- Alcohol and Drug dependence (except tobacco and caffeine) according to DSM-IV criteria using the French version of the Mini-International Neuropsychiatric Interview (MINI).
- Learning disability or difficulty with fluent use of the French language
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- Patient with mandatory care
- Long-Term use of non-psychotropic medication with psychotropic effects (opiates, Baclofen)
- Control group :
- History of mental retardation estimated by the French version of the National Adult Reading Test
- Neurological illness or any clinical condition that could affect cognitive performance (history of head injury with loss of consciousness lasting more than 5 minutes multiple sclerosis, stroke etc.)
- Current Mood disorder/ Lifetime Psychotic Disorder according to DSM-IV criteria using the French version of the Mini-International Neuropsychiatric Interview (MINI)
- Neither history of psychotic or affective disorders in a first-degree family member
- Alcohol and Drug dependence (except tobacco and caffeine) according to DSM-IV criteria using the French version of the Mini-International Neuropsychiatric Interview (MINI)
- Learning disability or difficulty with fluent use of the French language
- Long-Term use of non-psychotropic drugs with psychotropic effects (opiates, Baclofen) and psychotropic drugs
Trial locations and contacts
1 site in 1 country.
About this study
The facial emotion recognition is a basic social skill for successful social interactions. Several meta-analyses and recent studies found impairments of the perception of facial emotions in patients with euthymic bipolar disorder. Few studies compared recognition of facial emotions impairments during euthymia in patients with bipolar disorder type 1 and 2. These studies included low population samples (N<60). There were discrepancies in results of these studies. Szanto suggested that facial emotion recognition impairments were correlated with suicidal risk and social isolation. These impairments should be taking into account regarding psycho-social treatments in patients with bipolar disorder.
This study aims to evaluate facial emotion recognition in patients with bipolar I and II disorders compared to healthy controls, using the facial emotion recognition test (TREF). The objective of the present study is to compare TREF scores in a group of patients with bipolar 1, a group of patients with bipolar 2 disorder and a group with healthy controls. In addition, the investigators will investigate the relationships between TREF scores and levels of self-esteem and mental well-being.
- Being tested
- Facial emotion recognition test
- Keywords
- social cognition, facial emotion recognition, facial affect, bipolar disorder I and II
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Facial emotion recognition testOther
Facial emotion recognition test (TREF), questionnaires including self-administered questionnaires
| Study group | Role | What they receive |
|---|---|---|
| patients with bipolar disorder 1 | Experimental | Not described Receives: Other: Facial emotion recognition test |
| patients with bipolar disorder 2 | Experimental | Not described Receives: Other: Facial emotion recognition test |
| healthy controls | Active comparator | Not described Receives: Other: Facial emotion recognition test |
What is being measured
The primary outcome is the main question the study is designed to answer.
variation of TREF scores in tree groups of subjects
TREF scores in tree groups of subjects (group of patients with bipolar disorder 1, group of patients with bipolar disorder 2 and group of healthy controls.
Measured: 16 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2023
- Study start1 Apr 2020
- Primary completion1 May 2023
- Study completion1 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Social CognitionStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire, AmiensThe sponsor's other registered studies.
- 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Collaborators
- Centre Hospitalier le Vinatier, Pôle Ressource Évaluation et Réhabilitation Psycho-sociale, EPSM de l'Oise, Centre de santé mentale MGEN, Centre Hospitalier Philippe Pinel, Amiens
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05922956
- Sponsor's protocol ID
- PI2020_843_0009
- Acronym
- REF-BIP
- Status last verified
- Nov 2025
- First submitted
- 20 Jun 2023
- Last updated
- 19 Nov 2025
- 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 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Facial Emotion Recognition in Patients With Euthymic Bipolar Disorder I and II
- ClinicalTrials.gov ID
- NCT05922956
- Acronym / sponsor ID
- REF-BIP / PI2020_843_0009
- Keywords
- social cognition, facial emotion recognition, facial affect, bipolar disorder I and II
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Collaborators
- Centre Hospitalier le Vinatier, Pôle Ressource Évaluation et Réhabilitation Psycho-sociale, EPSM de l'Oise, Centre de santé mentale MGEN, Centre Hospitalier Philippe Pinel, Amiens
- Study start
- 1 Apr 2020 (actual)
- Primary completion
- 1 May 2023 (actual)
- Study completion
- 1 Jul 2023 (actual)
- First posted
- 28 Jun 2023 (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.
The facial emotion recognition is a basic social skill for successful social interactions. Several meta-analyses and recent studies found impairments of the perception of facial emotions in patients with euthymic bipolar disorder. Few studies compared recognition of facial emotions impairments during euthymia in patients with bipolar disorder type 1 and 2. These studies included low population samples (N<60). There were discrepancies in results of these studies. Szanto suggested that facial emotion recognition impairments were correlated with suicidal risk and social isolation. These impairments should be taking into account regarding psycho-social treatments in patients with bipolar disorder.
This study aims to evaluate facial emotion recognition in patients with bipolar I and II disorders compared to healthy controls, using the facial emotion recognition test (TREF). The objective of the present study is to compare TREF scores in a group of patients with bipolar 1, a group of patients with bipolar 2 disorder and a group with healthy controls. In addition, the investigators will investigate the relationships between TREF scores and levels of self-esteem and mental well-being.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| patients with bipolar disorder 1 | Experimental | Other: Facial emotion recognition test |
| patients with bipolar disorder 2 | Experimental | Other: Facial emotion recognition test |
| healthy controls | Active comparator | Other: Facial emotion recognition test |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Patient group :
- Male or female patients, between 18 and 60 years old
- Diagnosis of Bipolar Disorder I or Bipolar Disorder II according to DSM-IV criteria, using the French version of the Mini-International Neuropsychiatric Interview (MINI)
- Strictly euthymic defined by Hamilton Depression Rating Scale (17 items) ≤ 5 and Young Mania Rating Scale ≤ 5 for at least two months.
- Native French speakers
Key exclusion criteria (16 listed)
- Patient group :
- History of mental retardation assessed by the French version of the National Adult Reading Test
- Neurological illness or any clinical condition that could affect cognitive performance (history of head injury with loss of consciousness lasting more than 5 minutes multiple sclerosis, stroke etc.)
- Electroconvulsive therapy within the last 6 months
- Alcohol and Drug dependence (except tobacco and caffeine) according to DSM-IV criteria using the French version of the Mini-International Neuropsychiatric Interview (MINI).
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 |
|---|---|---|
| Facial emotion recognition testFacial emotion recognition test (TREF), questionnaires including self-administered questionnaires | Other | healthy controls, patients with bipolar disorder 1, patients with bipolar disorder 2 |
Primary outcome
variation of TREF scores in tree groups of subjects
Time frame: 16 months
TREF scores in tree groups of subjects (group of patients with bipolar disorder 1, group of patients with bipolar disorder 2 and group of healthy controls.
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 19 Nov 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Facial emotion recognition test in people with Social Cognition and Facial Emotion Recognition, run by Centre Hospitalier Universitaire, Amiens 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 11 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 19 Nov 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?
variation of TREF scores in tree groups of subjects (time frame: 16 months). 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 Nov 2025.