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

Pulmonary Langerhans Cell Histiocytosis Clinical Trial

— PsyHistio  

Official title:

Prevalence of Mood and Anxiety Disorders in Adult Patients With Pulmonary Langerhans Cell Histiocytosis: an Exploratory Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05114304
• Other study ID #: APHP210292
• Status: Not yet recruiting
• Start date: November 2021
• Est. completion date: November 2022

Study information

• Verified date: July 2021
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Abdellatif TAZI
• Phone: +33142499618
• Email: abdellatif.tazi[@]aphp.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: November 2022
• Est. primary completion date: November 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Anxiety Disorders
• Histiocytosis
• Histiocytosis, Langerhans-Cell
• Pulmonary Langerhans Cell Histiocytosis

Intervention

Other:
• Evaluation of co-morbid psychiatric disorders
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

Locations

Country	Name	City	State
France	Hôpital Saint-Louis, Centre de référence national des histiocytoses, Service de Pneumologie	Paris

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	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	Proportion of patients with at least one comorbid addictive disorder among: tobacco, alcohol, cannabis, benzodiazepines, cocaine, opiates	Definition and diagnosis of addictive disorder will be assessed with Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-5)	at inclusion
Secondary	Proportion of patients with active tobacco consumption with or without comorbid psychiatric disorder	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)	at inclusion
Secondary	Proportion of patients with persistent tobacco consumption despite nicotine replacement treatment	Tobacco consumption will be assessed by Fagerström survey and DSM-5 and expired carbon monoxide for patients with nicotine substitutes	at inclusion
Secondary	Number of previous tobacco weaning episodes and co-morbid psychiatric disorders		at inclusion
Secondary	Number of co-morbid psychiatric disorders		at inclusion
Secondary	Factors associated with psychiatric disorders as assessed by 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