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

November 8, 2021 updated by: Assistance Publique - Hôpitaux de Paris

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Paris, France
        • Hôpital Saint-Louis, Centre de référence national des histiocytoses, Service de Pneumologie
        • Contact:
          • Abdellatif TAZI

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adults with pulmonary Langerhans cell histiocytosis

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of patients with at least one of the disorders detailed in the Mini International Neuropsychiatric Interview (MINI) test
Time Frame: 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
at inclusion

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

November 1, 2021

Primary Completion (Anticipated)

November 1, 2022

Study Completion (Anticipated)

November 1, 2022

Study Registration Dates

First Submitted

October 18, 2021

First Submitted That Met QC Criteria

November 8, 2021

First Posted (Actual)

November 9, 2021

Study Record Updates

Last Update Posted (Actual)

November 9, 2021

Last Update Submitted That Met QC Criteria

November 8, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • APHP210292

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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