Efficacy Study of Low-Dose Hydrocortisone Treatment for Fibromyalgia

• Status: Completed
• Trial end date: 2007-06-01
• Target enrollment: 0
• Participant gender: All

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 administration of a very low-dose of cortisol which has no side effects corrects this deficiency and results in an improvement of symptoms

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ludwig-Maximilians - University of Munich
• Collaborator: University of Zurich
• Treatments: Cortisol succinate; Hydrocortisone; Hydrocortisone 17-butyrate 21-propionate; Hydrocortisone acetate

Criteria

Inclusion Criteria:

• FMS diagnosis according to the American College of Rheumatology 1990 Criteria.

• Age between 18 and 60 years

Exclusion Criteria:

• 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