Psychiatric Manifestations Associated With Behcet's Disease

Behçet's Disease, neuroBehcet, Anxiety, Depression, Tiredness Clinical Trial

— PSYCHO-B7  

Official title:

Psychiatric Manifestations Associated With Behcet's Disease

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04585360
• Other study ID #: 2019-A01819-48
• Status: Not yet recruiting
• Start date: October 10, 2020
• Est. completion date: February 15, 2021

Study information

• Verified date: August 2020
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Nicolas NN NOEL, MD PhD
• Phone: + 33 1 45 21 27 57
• Email: nicolas.noel[@]aphp.fr
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 25
• Est. completion date: February 15, 2021
• Est. primary completion date: February 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Behcet Syndrome
• Behçet's Disease, neuroBehcet, Anxiety, Depression, Tiredness

Intervention

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)

Locations

Country	Name	City	State
France	Internal medecine department	Le Kremlin-Bicetre	Val De Marne

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	SCL90-R questionnaire	Anxiety/depression symptoms questionnaire	Inclusion visit
Secondary	MINI questionnaire	Anxiety/depression symptoms questionnaire	Inclusion visit
Secondary	MFI questionnaire	Tiredness assessment	Inclusion visit
Secondary	SF36 questionnaire	Quality of life	Inclusion visit
Secondary	BSAS/BDCAF evaluation	Behçet's disease activity	Inclusion visit