Behçet's DiseasePSYCHO-B7NCT04585360
Psychiatric Manifestations Associated With Behcet's Disease
An observational study of Behçet's Disease and Psychiatric Disorders, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The psychoBehçet'study is aimed at evaluating the psychological and neurocognitive symptoms in 25 consecutive patients followed for Behçet's disease. This is a monocentric, observational, non interventional study. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Behçet's Disease, Psychiatric Disorders
- What is being tested?
- Questionnaires evaluating anxiety and depression symptoms, tiredness, and quality of life
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- 23 Jun 2020to 18 Dec 2020
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patient regularly monitored in the internal medicine department of Bicêtre
Who may be able to join
- Adult male or female
- Regular follow-up in the internal medicine department of Bicetre hospital
- Diagnosed with Behçet's disease
Who cannot join
- Refusal to participate in the study
- Poor command of the French language
- Patients under legal protection
- Pregnant woman
Trial locations and contacts
1 site in 1 country.
France1 site
Internal medecine department
Le Kremlin-Bicêtre, Val de Marne, 94275
About this study
The psychoBehçet'study is aimed at evaluating the psychological and neurocognitive symptoms in 25 consecutive patients followed for Behçet's disease. This is a monocentric, observational, non interventional study.
Read the detailed description
Patients will be evaluated during a day-care facility for Behçet's disease activity together with evaluation of anxiety and depression symptoms (SCL90-R and MINI assessments), fatigue (MFI) and quality of life (SF36).
- Conditions
- Behçet's Disease, Psychiatric Disorders
- Being tested
- Questionnaires evaluating anxiety and depression symptoms, tiredness, and quality of life
- Keywords
- NeuroBehçet, Anxiety, Depression, Tiredness
- Medical subject headings
- Behcet Syndrome, Mental Disorders, Anxiety Disorders, Depression, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Questionnaires evaluating anxiety and depression symptoms, tiredness, and quality of lifeOther
Realization of specific questionnaires evaluating:
- psychiatric symptoms (self-assessment according to the SLC-90R questionnaire and hetero-assessment by the internist doctor of the center according to the M.I.N.I. questionnaire)
- fatigue (Multidimensional Fatigue Inventory (MFI-20), French version, in self-assessment)
- quality of life (SF36 self-assessment questionnaire)
| Study group | Role | What they receive |
|---|---|---|
| Patient with Behcet disease | adult patient with Behcet's disease followed regularly in the internal medicine department of Bicetre Receives: Other: Questionnaires evaluating anxiety and depression symptoms, tiredness, and quality of life |
What is being measured
The primary outcome is the main question the study is designed to answer.
SCL90-R questionnaire
Anxiety/depression symptoms questionnaire
Measured: Inclusion visit
Secondary outcomes (4)
MINI questionnaire
Anxiety/depression symptoms questionnaire
Measured: Inclusion visit
Multidimensional Fatigue Inventory (MFI-20) questionnaire
Tiredness assessment
Measured: Inclusion visit
SF36 questionnaire
Quality of life
Measured: Inclusion visit
BSAS/BDCAF evaluation
Behçet's disease activity
Measured: Inclusion visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2020
- Study start23 Jun 2020
- Primary completion18 Dec 2020
- Study completion18 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Behçet's DiseaseStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- NOEL NN Nicolas, MD PhD, Principal investigator, APHP, Hôpital Bicetre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04585360
- Sponsor's protocol ID
- 2019-A01819-48
- Acronym
- PSYCHO-B7
- Status last verified
- Feb 2026
- First submitted
- 9 Oct 2020
- Last updated
- 11 Feb 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 11 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychiatric Manifestations Associated With Behcet's Disease
- ClinicalTrials.gov ID
- NCT04585360
- Acronym / sponsor ID
- PSYCHO-B7 / 2019-A01819-48
- Conditions
- Behçet's Disease, Psychiatric Disorders
- Keywords
- NeuroBehçet, Anxiety, Depression, Tiredness
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 23 Jun 2020 (actual)
- Primary completion
- 18 Dec 2020 (actual)
- Study completion
- 18 Dec 2020 (actual)
- First posted
- 14 Oct 2020 (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 psychoBehçet'study is aimed at evaluating the psychological and neurocognitive symptoms in 25 consecutive patients followed for Behçet's disease. This is a monocentric, observational, non interventional study.
Detailed description
Patients will be evaluated during a day-care facility for Behçet's disease activity together with evaluation of anxiety and depression symptoms (SCL90-R and MINI assessments), fatigue (MFI) and quality of life (SF36).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient with Behcet disease | – | Other: Questionnaires evaluating anxiety and depression symptoms, tiredness, and quality of lifeadult patient with Behcet's disease followed regularly in the internal medicine department of Bicetre |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patient regularly monitored in the internal medicine department of Bicêtre
Key inclusion criteria (3 listed)
- Adult male or female
- Regular follow-up in the internal medicine department of Bicetre hospital
- Diagnosed with Behçet's disease
Key exclusion criteria (4 listed)
- Refusal to participate in the study
- Poor command of the French language
- Patients under legal protection
- Pregnant woman
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 |
|---|---|---|
| Questionnaires evaluating anxiety and depression symptoms, tiredness, and quality of lifeRealization of specific questionnaires evaluating: * psychiatric symptoms (self-assessment according to the SLC-90R questionnaire and hetero-assessment by the internist doctor of the center according to the M.I.N.I. questionnaire) * fatigue (Multidimensional Fatigue Inventory (MFI-20), French version, in self-assessment) * quality of life (SF36 self-assessment questionnaire) | Other | Patient with Behcet disease |
Primary outcome
SCL90-R questionnaire
Time frame: Inclusion visit
Anxiety/depression symptoms questionnaire
4 secondary outcomes
MINI questionnaire
Time frame: Inclusion visit
Multidimensional Fatigue Inventory (MFI-20) questionnaire
Time frame: Inclusion visit
SF36 questionnaire
Time frame: Inclusion visit
BSAS/BDCAF evaluation
Time frame: Inclusion visit
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 11 Feb 2026.
- Individual participant dataSharing planned: No
Related trials for Behçet's Disease
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Corticotropin for Behçet's Disease: A Multicenter Randomized Controlled TrialAcronym.
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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.
NOEL NN Nicolas, MD PhD principal investigator
APHP, Hôpital Bicetre
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 Behçet's Disease and Psychiatric Disorders, run by Assistance Publique - Hôpitaux de Paris 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 3 inclusion and 4 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 11 Feb 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?
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?
SCL90-R questionnaire (time frame: Inclusion visit). 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 11 Feb 2026.