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

NCT05114304 | Unknown

• 1 other identifier: APHP210292
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Pulmonary Langerhans Cell Histiocytosis

Outcome Measures

Primary Outcomes (1)

• Proportion of patients with at least one of the disorders detailed in the Mini International Neuropsychiatric Interview (MINI) test

  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

  at inclusion

Secondary Outcomes (6)

• Proportion of patients with at least one comorbid addictive disorder among: tobacco, alcohol, cannabis, benzodiazepines, cocaine, opiates

  at inclusion

• Proportion of patients with active tobacco consumption with or without comorbid psychiatric disorder

  at inclusion

• Proportion of patients with persistent tobacco consumption despite nicotine replacement treatment

  at inclusion

• Number of previous tobacco weaning episodes and co-morbid psychiatric disorders

  at inclusion

• Number of co-morbid psychiatric disorders

  at inclusion

Study Arms (1)

Pulmonary Langerhans cell histiocytosis (PLCH)

Adults with pulmonary Langerhans cell histiocytosis

Other: Evaluation of co-morbid psychiatric disorders

Interventions

Evaluation of co-morbid psychiatric disorders OTHER

Added scales : * Mini Internationnal Neuropsychiatric Interview * Fagerström test * DSM-5 Scale Additional dosage : - a urine sample will be taken to evaluate the presence of tobacco and nicotine breakdown products and the presence of various toxics Expired carbon monoxide for patients using nicotine substitutes

Pulmonary Langerhans cell histiocytosis (PLCH)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults with pulmonary Langerhans cell histiocytosis

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Hôpital Saint-Louis, Centre de référence national des histiocytoses, Service de Pneumologie

Paris, France

Location

MeSH Terms

Conditions

Histiocytosis, Langerhans-Cell

Condition Hierarchy (Ancestors)

Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases; Histiocytosis; Lymphatic Diseases; Hemic and Lymphatic Diseases

Central Study Contacts

Abdellatif TAZI

CONTACT

+33142499618; abdellatif.tazi@aphp.fr

Matthieu Resche-Rigon, Pr

CONTACT

+33142499742; matthieu.resche-rigon@u-paris.fr

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 18, 2021
• First Posted: November 9, 2021
• Study Start: November 1, 2021
• Primary Completion: November 1, 2022
• Study Completion: November 1, 2022
• Last Updated: November 9, 2021

Record last verified: 2021-07

Locations

FR (1)