Prevalence of Mood and Anxiety Disorders in Adult Patients With Pulmonary Langerhans Cell Histiocytosis

• Conditions: Pulmonary Langerhans Cell Histiocytosis

• Registration Number: NCT05114304
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Brief Summary

Pulmonary Langerhans cell histiocytosis (PLCH) is a rare disease, of unknown etiology, that occurs almost exclusively in smokers.The clinical experience suggests a high prevalence of anxiety symptoms and an addictive profile. However, no study to date has precisely investigated the prevalence of co-morbid psychiatric disorders in this population.The aim of the study is to evaluate the prevalence of co-morbid psychiatric disorders in adult PLCH patients.

This study should allow:

* to assess the prevalence of psychiatric disorders co-morbid in PLCH patients

* a targeted and more effective management of patients

* a better response rate to smoking and cannabis weaning, that represents a major goal for these patients.

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-07
• Study First Submitted: 2021-10-18
• Study Start: 2021-11
• Study First Submitted QC: 2021-11-08
• Last Update Submitted: 2021-11-08
• Study First Posted: 2021-11-09
• Last Update Posted: 2021-11-09
• Primary Completion: 2022-11
• Study Completion: 2022-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Patients of 18 years of age or older with PLCH diagnosed at adulthood
• Patients affiliated to the French Health Care System
• Informed patients

Exclusion Criteria

• Patient unable to understand the interview (language barrier)
• Patient under guardianship or curatorship
• Patient under AME (French medical help for foreigners)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proportion of patients with at least one of the disorders detailed in the Mini International Neuropsychiatric Interview (MINI) test	at inclusion	The Mini-International Neuropsychiatric Interview (M.I.N.I.) is a structured diagnostic interview (40 minutes duration), exploring in a standardized way the main psychiatric disorders of Axis I of the DSM-IV TR (American Psychiatric Association), namely 14 items with a binary result for each specified disorder

Secondary Outcome Measures

Name	Time	Method
Proportion of patients with active tobacco consumption with or without comorbid psychiatric disorder	at inclusion	Tobacco consumption will be assessed by Fagerström survey and DSM-5, cotinine in urine quantification and expired carbon monoxide for patients using nicotine substitutes. Fargerstrom test evaluates the dependence on cigarettes from 0 to 10 (0 indicated a very low dependence and 10 a very strong dependence)
Proportion of patients with persistent tobacco consumption despite nicotine replacement treatment	at inclusion	Tobacco consumption will be assessed by Fagerström survey and DSM-5 and expired carbon monoxide for patients with nicotine substitutes
Proportion of patients with at least one comorbid addictive disorder among: tobacco, alcohol, cannabis, benzodiazepines, cocaine, opiates	at inclusion	Definition and diagnosis of addictive disorder will be assessed with Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-5)
Number of co-morbid psychiatric disorders	at inclusion
Factors associated with psychiatric disorders as assessed by Mini International Neuropsychiatric Interview (MINI) test	at inclusion	The Mini-International Neuropsychiatric Interview (M.I.N.I.) is a structured diagnostic interview (40 minutes duration), exploring in a standardized way the main psychiatric disorders of Axis I of the DSM-IV TR (American Psychiatric Association), namely 14 items with a binary result for each specified disorder
Number of previous tobacco weaning episodes and co-morbid psychiatric disorders	at inclusion

Trial Locations

Locations (1)

Hôpital Saint-Louis, Centre de référence national des histiocytoses, Service de Pneumologie; 🇫🇷 Paris, France