Completed

Phase 4
Age: 18Years - 60Years
All Genders
ID00000428

Combining N-of-1 Trials to Assess Fibromyalgia Therapies

Led by Tufts Medical Center · Updated on 2013-08-01

58

Participants Needed

7

Research Sites

N/A

Total Duration

On this page

Sponsors

T

Tufts Medical Center

Lead Sponsor

N

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Combining N-of-1 Trials to Assess Fibromyalgia Treatments

Who Can Participate

Age: 18Years - 60Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
Not Eligible

You will not qualify if you...

  • 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

Trial Site Locations

Total: 7 locations

1

Office of Raphael Kieval, MD

Brockton, Massachusetts, United States, 02402

Status Unknown

2

Office of Ronald J. Rapoport, MD

Fall River, Massachusetts, United States, 02720

Status Unknown

3

Office of Eileen Winston, MD

Framingham, Massachusetts, United States, 01702

Status Unknown

4

Office of Nicola Mogavero, MD

Melrose, Massachusetts, United States, 02176

Status Unknown

5

Office of Jacqueline Feuer, MD

Needham, Massachusetts, United States, 02192

Status Unknown

6

Newton-Wellesley Hospital

Newton, Massachusetts, United States, 02162

Status Unknown

7

Office of Sharon A. Stotsky, MD

North Reading, Massachusetts, United States, 01864

Status Unknown

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

TREATMENT

Number of Arms

1

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Published Research Related To This Trial

Combining single patient (N-of-1) trials to estimate population treatment effects and to evaluate individual patient responses to treatment.

D R Zucker, C H Schmid, M W McIntosh...

https://pubmed.ncbi.nlm.nih.gov/9179098