Status:
COMPLETED
Efficacy Study of Low-Dose Hydrocortisone Treatment for Fibromyalgia
Lead Sponsor:
Ludwig-Maximilians - University of Munich
Collaborating Sponsors:
University of Zurich
Conditions:
Fibromyalgia
Eligibility:
All Genders
18-60 years
Phase:
EARLY_PHASE1
Brief Summary
This study is based on clinical findings that some patients with fibromyalgia have a tendency towards lower levels of the stress hormone cortisol. The hypothesis to be tested in this study is that the...
Detailed Description
Fibromyalgia (FMS) is regarded as one of the most important chronic pain syndromes with a high prevalence in the general population. Hypotheses to be tested in this study: * Impaired glucocorticoid ...
Eligibility Criteria
Inclusion
- FMS diagnosis according to the American College of Rheumatology 1990 Criteria.
- Age between 18 and 60 years
Exclusion
- Disease states representing contraindications to the administration of glucocorticoids (tuberculosis, gastric- and duodenal ulcers, Cushing's disease, osteoporosis, hypertension, pregnancy and lactation, psychosis, glaucoma, diabetes mellitus, thrombophilia, active or chronic bacterial or viral infections, hypothyreosis, cirrhosis)
- Severe or chronic somatic diseases
- Psychiatric diseases according to DSM-IV (except PTSD, minor depressive episodes, minor personality disorders)
- Body weight \>20% above or below normal
- Changes in pharmacologic or psychotherapeutic management less than 3 months ago
- Age \< 18 years
Key Trial Info
Start Date :
May 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2007
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00236925
Start Date
May 1 2003
End Date
June 1 2007
Last Update
March 15 2024
Active Locations (1)
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1
Ludwig-Maximilians University
Munich, Bavaria, Germany, 81377