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Combining N-of-1 Trials to Assess Fibromyalgia Treatments

NCT00000428 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 58

Last updated 2013-08-01

No results posted yet for this study

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.

Conditions

  • Fibromyalgia

Interventions

DRUG

Amitriptyline

Amitriptyline 25 mg po

DRUG

Amitriptyline plus Fluoxitine

Amitriptyline 25 mg po plus Fluoxitine 20 mg po

Sponsors & Collaborators

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

    collaborator NIH

  • Tufts Medical Center

    lead OTHER

Principal Investigators

  • Deborah R. Zucker · New England Medical Center, Tufts University School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2000-09-30
Primary Completion
2004-03-31
Completion
2004-03-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00000428 on ClinicalTrials.gov