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

Sponsor
Assistance Publique - Hôpitaux de Paris (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05114304
Collaborator
(none)
100
1
12
8.3

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Evaluation of co-morbid psychiatric disorders

Study Design

Study Type:
Observational
Anticipated Enrollment :
100 participants
Observational Model:
Other
Time Perspective:
Cross-Sectional
Official Title:
Prevalence of Mood and Anxiety Disorders in Adult Patients With Pulmonary Langerhans Cell Histiocytosis: an Exploratory Study
Anticipated Study Start Date :
Nov 1, 2021
Anticipated Primary Completion Date :
Nov 1, 2022
Anticipated Study Completion Date :
Nov 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Pulmonary Langerhans cell histiocytosis (PLCH)

Adults with pulmonary Langerhans cell histiocytosis

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

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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)

  2. 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)

  3. 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

  4. Number of previous tobacco weaning episodes and co-morbid psychiatric disorders [at inclusion]

  5. Number of co-morbid psychiatric disorders [at inclusion]

  6. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hôpital Saint-Louis, Centre de référence national des histiocytoses, Service de Pneumologie Paris France

Sponsors and Collaborators

  • Assistance Publique - Hôpitaux de Paris

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT05114304
Other Study ID Numbers:
  • APHP210292
First Posted:
Nov 9, 2021
Last Update Posted:
Nov 9, 2021
Last Verified:
Jul 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 9, 2021