Combining N-of-1 Trials to Assess Fibromyalgia Treatments

NCT00000428 | Completed Phase 4 DMC

• 2 other identifiers: R01AR045416NIAMS-038
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 7

Brief 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

Keywords

Fibromyalgia Syndrome (FMS); Amitriptyline; Fluoxetine

Outcome Measures

Primary Outcomes (1)

• FIbromyalgia Impact Questionnaire scores

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

Study Arms (1)

1

EXPERIMENTAL

Patients received each intervention multiple times in random-order crossover design.

Drug: Amitriptyline; Drug: Amitriptyline plus Fluoxitine

Interventions

Amitriptyline DRUG

Amitriptyline 25 mg po

Also known as: Elavil

1

Amitriptyline plus Fluoxitine DRUG

Amitriptyline 25 mg po plus Fluoxitine 20 mg po

Also known as: elavil plus prozac

1

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

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

Sponsors & Collaborators

• Tufts Medical Center: lead
• National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS): collaborator

Study Sites (7)

Office of Raphael Kieval, MD

Brockton, Massachusetts, 02402, United States

Location

Office of Ronald J. Rapoport, MD

Fall River, Massachusetts, 02720, United States

Location

Office of Eileen Winston, MD

Framingham, Massachusetts, 01702, United States

Location

Office of Nicola Mogavero, MD

Melrose, Massachusetts, 02176, United States

Location

Office of Jacqueline Feuer, MD

Needham, Massachusetts, 02192, United States

Location

Newton-Wellesley Hospital

Newton, Massachusetts, 02162, United States

Location

Office of Sharon A. Stotsky, MD

North Reading, Massachusetts, 01864, United States

Location

Related Publications (6)

• Goldenberg D, Mayskiy M, Mossey C, Ruthazer R, Schmid C. A randomized, double-blind crossover trial of fluoxetine and amitriptyline in the treatment of fibromyalgia. Arthritis Rheum. 1996 Nov;39(11):1852-9. doi: 10.1002/art.1780391111.

  PMID: 8912507 BACKGROUND

• Zucker DR, Schmid CH, McIntosh MW, D'Agostino RB, Selker HP, Lau J. Combining single patient (N-of-1) trials to estimate population treatment effects and to evaluate individual patient responses to treatment. J Clin Epidemiol. 1997 Apr;50(4):401-10. doi: 10.1016/s0895-4356(96)00429-5.

  PMID: 9179098 BACKGROUND

• Guyatt G, Sackett D, Taylor DW, Chong J, Roberts R, Pugsley S. Determining optimal therapy--randomized trials in individual patients. N Engl J Med. 1986 Apr 3;314(14):889-92. doi: 10.1056/NEJM198604033141406.

  PMID: 2936958 BACKGROUND

• Guyatt G, Sackett D, Adachi J, Roberts R, Chong J, Rosenbloom D, Keller J. A clinician's guide for conducting randomized trials in individual patients. CMAJ. 1988 Sep 15;139(6):497-503.

  PMID: 3409138 BACKGROUND

• Larson EB. N-of-1 clinical trials. A technique for improving medical therapeutics. West J Med. 1990 Jan;152(1):52-6.

  PMID: 2309473 BACKGROUND

• Zucker DR, Ruthazer R, Schmid CH, Feuer JM, Fischer PA, Kieval RI, Mogavero N, Rapoport RJ, Selker HP, Stotsky SA, Winston E, Goldenberg DL. Lessons learned combining N-of-1 trials to assess fibromyalgia therapies. J Rheumatol. 2006 Oct;33(10):2069-77.

  PMID: 17014022 RESULT

MeSH Terms

Conditions

Fibromyalgia

Interventions

Amitriptyline; Fluoxetine

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Dibenzocycloheptenes; Benzocycloheptenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Propylamines; Amines

Study Officials

• Deborah R. Zucker

  New England Medical Center, Tufts University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 18, 2000
• First Posted: January 19, 2000
• Study Start: September 1, 2000
• Primary Completion: March 1, 2004
• Study Completion: March 1, 2004
• Last Updated: August 1, 2013

Record last verified: 2013-07

Locations

US (7)