Combining N-of-1 Trials to Assess Fibromyalgia Treatments

• Status: Completed
• Trial end date: 2004-03-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will compare the effectiveness of combination therapy with the drugs amitriptyline and fluoxetine (AM+FL) and amitriptyline (AM) alone in the treatment of people with fibromyalgia. Doctors will treat each study participant with both AM + FL and AM alone for 6 weeks at a time. The study uses a method that combines results from treatment of individual patients to assess overall treatment effectiveness and help individual patients and their physicians with their treatment decisions. This study will also help compare the results of community-based studies (studies involving private doctors) and studies based at clinical research centers.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Tufts Medical Center
• Collaborator: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
• Treatments: Amitriptyline; Amitriptyline, perphenazine drug combination

Criteria

Inclusion Criteria:

• Patients who meet fibromyalgia criteria as defined by the American College of Rheumatology

• No systemic illness (current or past) or other contraindications to taking study medications (e.g. known hypersensitivity)

• Age 18-60

• Patient willingness, and physician agreement, to discontinue CNS medications/NSAIDs/analgesics for 1 week prior to starting their trial

• Patient informed consent and agreement to participate in an N-of-1 trial

Exclusion Criteria:

• Patients who are currently pregnant or who plan to become pregnant during the study period

• Patients with any contraindications to using either amitriptyline or fluoxetine