Efficacy Study of Low-Dose Hydrocortisone Treatment for Fibromyalgia

NCT00236925 | Completed Early Phase 1 DMC

• 1 other identifier: 348/02
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Conditions

Fibromyalgia

Keywords

Fibromyalgia; Cortisol; Hydrocortisone; Stress

Outcome Measures

Primary Outcomes (1)

• Fibromyalgia symptoms

  3 months

Secondary Outcomes (4)

• Chronic stress symptoms

  3 months

• Health-related quality of life

  3 months

• Life satisfaction

  3 months

• Infection

  3 months

Study Arms (2)

Low dose Hydrocortisone

ACTIVE COMPARATOR

Low Dose Hydrocortisone

Drug: Low dose Hydrocortisone; Drug: Placebo

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Low dose Hydrocortisone; Drug: Placebo

Interventions

Low dose Hydrocortisone DRUG

Hydrocortisone 10 mg daily

Also known as: Cortisol

Low dose Hydrocortisone; Placebo

Placebo DRUG

Placebo

Low dose Hydrocortisone; Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• FMS diagnosis according to the American College of Rheumatology 1990 Criteria.
• Age between 18 and 60 years

You may not qualify if:

• 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

Sponsors & Collaborators

• Ludwig-Maximilians - University of Munich: lead
• University of Zurich: collaborator

Study Sites (1)

Ludwig-Maximilians University

Munich, Bavaria, 81377, Germany

Location

Related Publications (1)

• Aerni A, Traber R, Hock C, Roozendaal B, Schelling G, Papassotiropoulos A, Nitsch RM, Schnyder U, de Quervain DJ. Low-dose cortisol for symptoms of posttraumatic stress disorder. Am J Psychiatry. 2004 Aug;161(8):1488-90. doi: 10.1176/appi.ajp.161.8.1488.

  PMID: 15285979 BACKGROUND

Related Links

• Homepage of the Dept. of Anaesthesiology of the University of Munich

MeSH Terms

Conditions

Fibromyalgia

Interventions

Hydrocortisone

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; 11-Hydroxycorticosteroids; Hydroxycorticosteroids; Adrenal Cortex Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; 17-Hydroxycorticosteroids

Study Officials

• Gustav Schelling, MD, PhD

  Ludwig-Maximilians - University of Munich

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Researcher

Study Record Dates

• First Submitted: October 10, 2005
• First Posted: October 12, 2005
• Study Start: May 1, 2003
• Primary Completion: May 1, 2007
• Study Completion: June 1, 2007
• Last Updated: March 15, 2024

Record last verified: 2024-03

Locations

DE (1)