Search / Trial NCT00000428

Combining N-of-1 Trials to Assess Fibromyalgia Treatments

Launched by TUFTS MEDICAL CENTER · Jan 18, 2000

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Trial Information

Current as of December 10, 2023

Completed

Keywords

Fibromyalgia Syndrome (Fms) Amitriptyline Fluoxetine

Description

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

Attachments

readout_NCT00000428_2023-12-10.pdf

4.5 MB

NCT00000428_study_protocol.pdf

4.5 MB

About company

The National Institute of Allergy and Infectious Diseases (NIAID, /ˈnaɪ.æd/) is one of the 27 institutes and centers that make up the National Institutes of Health (NIH), an agency of the United States Department of Health and Human Services (HHS). NIAID's mission is to conduct basic and applied research to better understand, treat, and prevent infectious, immunologic, and allergic diseases.

Contacts

JC

Jennifer Cobb

Immunology at National Institute of Allergy and Infectious Diseases (NIAID)

Locations

Brockton, Massachusetts, United States

Fall River, Massachusetts, United States

Framingham, Massachusetts, United States

Melrose, Massachusetts, United States

Needham, Massachusetts, United States

Newton, Massachusetts, United States

North Reading, Massachusetts, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

At baseline,each treatment period, and at 3 mo follow up

Reviews (48)

4.6

All reviews come from applied patients

5 stars
41
4 stars
6
3 stars
2
2 stars
0
1 stars
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Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Michael Foster
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Dries Vincent
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

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