Combining N-of-1 Trials to Assess Fibromyalgia Treatments

Completed · Phase 4

Conditions studied: Fibromyalgia

In brief

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.

Key facts

Study ID

NCT00000428

Run by

Tufts Medical Center

People needed

58

Starts

2000-09-01

Expected to finish

2004-03-01

Last updated by the study team

2013-08-01

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Office of Raphael Kieval, MD — Brockton, Massachusetts, United States
• Office of Ronald J. Rapoport, MD — Fall River, Massachusetts, United States
• Office of Eileen Winston, MD — Framingham, Massachusetts, United States
• Office of Nicola Mogavero, MD — Melrose, Massachusetts, United States
• Office of Jacqueline Feuer, MD — Needham, Massachusetts, United States
• Newton-Wellesley Hospital — Newton, Massachusetts, United States
• Office of Sharon A. Stotsky, MD — North Reading, Massachusetts, United States

Full record on ClinicalTrials.gov

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