Psychiatric Manifestations Associated With Behcet's Disease (PSYCHO-B7)

February 9, 2026 updated by: Assistance Publique - Hôpitaux de Paris
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Val de Marne
      • Le Kremlin-Bicêtre, Val de Marne, France, 94275
        • Internal medecine department

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Adult patient regularly monitored in the internal medicine department of Bicêtre

Description

Inclusion Criteria:

  • Adult male or female
  • Regular follow-up in the internal medicine department of Bicetre hospital
  • Diagnosed with Behçet's disease

Exclusion Criteria:

  • Refusal to participate in the study
  • Poor command of the French language
  • Patients under legal protection
  • Pregnant woman

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patient with Behcet disease
adult patient with Behcet's disease followed regularly in the internal medicine department of Bicetre
Other: Questionnaires evaluating anxiety and depression symptoms, tiredness, and quality of life

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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
SCL90-R questionnaire
Time Frame: Inclusion visit
Anxiety/depression symptoms questionnaire
Inclusion visit

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
MINI questionnaire
Time Frame: Inclusion visit
Anxiety/depression symptoms questionnaire
Inclusion visit
SF36 questionnaire
Time Frame: Inclusion visit
Quality of life
Inclusion visit
BSAS/BDCAF evaluation
Time Frame: Inclusion visit
Behçet's disease activity
Inclusion visit
Multidimensional Fatigue Inventory (MFI-20) questionnaire
Time Frame: Inclusion visit
Tiredness assessment
Inclusion visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Investigators

  • Principal Investigator: NOEL NN Nicolas, MD PhD, APHP, Hôpital Bicetre

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 23, 2020

Primary Completion (Actual)

December 18, 2020

Study Completion (Actual)

December 18, 2020

Study Registration Dates

First Submitted

October 9, 2020

First Submitted That Met QC Criteria

October 9, 2020

First Posted (Actual)

October 14, 2020

Study Record Updates

Last Update Posted (Actual)

February 11, 2026

Last Update Submitted That Met QC Criteria

February 9, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019-A01819-48

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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