Combining N-of-1 Trials to Assess Fibromyalgia Treatments

Launched by TUFTS MEDICAL CENTER · Jan 18, 2000

Keywords

ClinConnect Summary

This study will use the combined N-of-1 method to compare the effectiveness of the combination therapy amitriptyline and fluoxetine (AM+FL) versus amitriptyline (AM) alone in patients with fibromyalgia (FM). It will also compare community-based and center-based trial results. We will ask community-based, board-certified rheumatologists to participate as investigators and we will also carry out a center-based study (at Newton-Wellesley Hospital). Physicians will ask patients meeting eligibility criteria to participate in this study and undergo an N-of-1 trial.

Each N-of-1 trial will consist...

Gender

ALL

Eligibility 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