Trial document





This trial has been registered retrospectively.
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  DRKS00011120

Trial Description

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Title

Prevalence of psychiatric co-morbidities in patients with early musculosceletal rheumatic diseases and non inflammatory joint diseases vs.patients without any joint disease and/or pain syndroms

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Trial Acronym

PSY-RA

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Psychological co-morbidities, especially the depression, are one of the most prevalent co-morbidities in patients with manifest rheumatoid arthritis. This observational study investigates the prevalence of psychiatric-psychological co-morbidities (e.g. posttraumatic disorders, depression, anxiety and childhood abuse) of patients who have an early arthritis with a maximum disease duration of 12 months and no special rheumatic therapy. The aim of this study is to find out the relevance of these co-morbidities at an early stage of disease to approve new strategies of prevention and screening instruments for rheumatologists. Therefor patients get a questionnaire package as well as a structured psychiatric interview. Additionally there will be collected blodd and saliva samples to measure cortisol levels and other cytokines.

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Brief Summary in Scientific Language

This study investigates prevalence rates of psychiatric co-morbidities in a sample of early musculosceletal-rheumatic diseases in comparison to matched healthy controls, as well as potential immunological risk factors that influence the early manifestation of rheumatic diseases. Patients get questionnaires that embrcace psychological problems and a structured psychiatric interview by DSM V. Subsidiary blood and saliva samples will be collected which may variate between patients with or without inflammation and psychiatric disorders.

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Organizational Data

  •   DRKS00011120
  •   2017/06/22
  •   [---]*
  •   yes
  •   Approved
  •   EA1/063/15, Ethik-Kommission der Charité -Universitätsmedizin Berlin-
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   M13.0 -  Polyarthritis, unspecified
  •   F43 -  Reaktionen auf schwere Belastungen und Anpassungsstörungen
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Interventions/Observational Groups

  •   Patients with early musculosceletal-rheumatic joint diseases get a psychological questionnaire package as well as a structured psychiatric interview. Additionally there will be collected blodd and saliva samples to measure cortisol levels and other cytokines in a subgroup.
  •   Controlls without any rheumatic disaeses but joint pain or no pain, get a psychological questionnaire package as well as a structured psychiatric interview. Additionally there will be collected blodd and saliva samples to measure cortisol levels and other cytokines in a subgroup.
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Characteristics

  •   Non-interventional
  •   Other
  •   Non-randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Other
  •   Diagnostic
  •   Other
  •   N/A
  •   N/A
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Primary Outcome

Prevalence of psychiatric co-morbidities (by means of a psychological questionnaire package as well as a structured psychiatric interview) in early arthritis patients.

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Secondary Outcome

Determination of cytocines, sensitivity of glococorticoid receptors at timepoint of diagnosis.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2015/10/01
  •   180
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

The patient
• has nflammatory and non-inflammatory joint symptoms and/or fulfills the ACR/EULAR criteria of an early RA of 2010 with a symptom duration of at least four weeks and a maximum of 12 months
• agrees with data collection of disease data and sample collection/sample use.

Age and gender-matched control population:
• Excluded inflammatory-systemic rheumatic disease
• has no other inflammatory systemic disease of the rheumatic diseases.

For all participants:
• Age ≥ 18 years,
• There is a written consent to the survey of self-questionnaire questionnaire

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Exclusion Criteria

The patient
• has a known psychiatric disorder that limits the understanding of the project plan (not consentable)
• does not agree and/or is not able to sign the declaration of consent
• is a prisoner or a person placed in an institution on the basis of an administrative or judicial order

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Addresses

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    • Charité-Universitätsmedizin BerlinKlinik m.S. Rheumatologie und Klinische Immunologie
    • Mr.  Prof.  Gerd R.  Burmestert 
    • Charitéplatz 1
    • 10117  Berlin
    • Germany
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    • Charité-Universitätsmedizin BerlinInstitut für Medizinische Psychologie
    • Ms.  Prof.  Christine  Heim 
    • Luisenstraße 57
    • 10117  Berlin
    • Germany
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    • Charité-Universitätsmedizin Berlin; Klinik für Rheumatologie und Klinische Immunologie
    • Ms.  Dr. med.  Jacqueline  Detert 
    • Charitéplatz 1
    • 10117  Berlin
    • Germany
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    • Charité Universitätsmedizin Berlin Klinik für Rheumatologie und klin. Immunologie
    • Ms.  Desiree  Freier 
    • Charitéplatz 1
    • 10117  Belrin
    • Germany
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Sources of Monetary or Material Support

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    • Charité Universitätsmedizin BerlinKlinik für Rheumatologie und klin. Immunologie
    • Ms.  Dr. med  Jacqueline  Detert 
    • Charitéplatz 1
    • 10117  Belrin
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.