Skip to main content

Main menu

  • Home
  • Content
    • First Release
    • Current
    • Archives
    • Collections
    • Audiovisual Rheum
    • COVID-19 and Rheumatology
  • Resources
    • Guide for Authors
    • Submit Manuscript
    • Payment
    • Reviewers
    • Advertisers
    • Classified Ads
    • Reprints and Translations
    • Permissions
    • Meetings
    • FAQ
    • Policies
  • Subscribers
    • Subscription Information
    • Purchase Subscription
    • Your Account
    • Terms and Conditions
  • About Us
    • About Us
    • Editorial Board
    • Letter from the Editor
    • Duncan A. Gordon Award
    • Privacy/GDPR Policy
    • Accessibility
  • Contact Us
  • JRheum Supplements
  • Services

User menu

  • My Cart
  • Log In

Search

  • Advanced search
The Journal of Rheumatology
  • JRheum Supplements
  • Services
  • My Cart
  • Log In
The Journal of Rheumatology

Advanced Search

  • Home
  • Content
    • First Release
    • Current
    • Archives
    • Collections
    • Audiovisual Rheum
    • COVID-19 and Rheumatology
  • Resources
    • Guide for Authors
    • Submit Manuscript
    • Payment
    • Reviewers
    • Advertisers
    • Classified Ads
    • Reprints and Translations
    • Permissions
    • Meetings
    • FAQ
    • Policies
  • Subscribers
    • Subscription Information
    • Purchase Subscription
    • Your Account
    • Terms and Conditions
  • About Us
    • About Us
    • Editorial Board
    • Letter from the Editor
    • Duncan A. Gordon Award
    • Privacy/GDPR Policy
    • Accessibility
  • Contact Us
  • Follow jrheum on Twitter
  • Visit jrheum on Facebook
  • Follow jrheum on LinkedIn
  • Follow jrheum on YouTube
  • Follow jrheum on Instagram
  • Follow jrheum on RSS
Research ArticleArticle

The Efficacy and Safety of Milnacipran for Treatment of Fibromyalgia. A Randomized, Double-blind, Placebo-controlled Trial

PHILIP J. MEASE, DANIEL J. CLAUW, R. MICHAEL GENDREAU, SRINIVAS G. RAO, JAY KRANZLER, WEI CHEN and ROBERT H. PALMER
The Journal of Rheumatology February 2009, 36 (2) 398-409; DOI: https://doi.org/10.3899/jrheum.080734
PHILIP J. MEASE
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
  • For correspondence: pmease@philipmease.com
DANIEL J. CLAUW
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
R. MICHAEL GENDREAU
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
SRINIVAS G. RAO
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
JAY KRANZLER
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
WEI CHEN
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
ROBERT H. PALMER
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
  • Article
  • Figures & Data
  • References
  • Info & Metrics
  • PDF
  • eLetters
PreviousNext
Loading

REFERENCES

  1. 1.↵
    1. Hudson JI,
    2. Pope HG, Jr
    . The relationship between fibromyalgia and major depressive disorder. Rheum Dis Clin North Am 1996;22:285–303.
    OpenUrlCrossRefPubMed
  2. 2.↵
    1. Wolfe F,
    2. Smythe HA,
    3. Yunus MB,
    4. et al
    . The American College of Rheumatology 1990 criteria for the classification of fibromyalgia. Report of the Multicenter Criteria Committee. Arthritis Rheum 1990;33:160–72.
    OpenUrlCrossRefPubMed
  3. 3.↵
    1. Mease P
    . Fibromyalgia syndrome: review of clinical presentation, pathogenesis, outcome measures, and treatment. J Rheumatol 2005;32 Suppl 756–21.
    OpenUrlFREE Full Text
  4. 4.↵
    1. Baker K,
    2. Barkhuizen A
    . Pharmacologic treatment of fibromyalgia. Curr Pain Headache Rep 2005;9:301–6.
    OpenUrlCrossRefPubMed
  5. 5.↵
    1. Wolfe F,
    2. Ross K,
    3. Anderson J,
    4. Russell IJ,
    5. Hebert L
    . The prevalence and characteristics of fibromyalgia in the general population. Arthritis Rheum 1995;38:19–28.
    OpenUrlCrossRefPubMed
  6. 6.↵
    1. Clauw DJ,
    2. Chrousos GP
    . Chronic pain and fatigue syndromes: overlapping clinical and neuroendocrine features and potential pathogenic mechanisms. Neuroimmunomodulation 1997;4:134–53.
    OpenUrlPubMed
  7. 7.
    1. Yunus MB
    . Towards a model of pathophysiology of fibromyalgia: aberrant central pain mechanisms with peripheral modulation. J Rheumatol 1992;19:846–50.
    OpenUrlPubMed
  8. 8.↵
    1. Bradley LA,
    2. McKendree-Smith NL,
    3. Alberts KR,
    4. Alarcon GS,
    5. Mountz JM,
    6. Deutsch G
    . Use of neuroimaging to understand abnormal pain sensitivity in fibromyalgia. Curr Rheumatol Rep 2000;2:141–8.
    OpenUrlCrossRefPubMed
  9. 9.↵
    1. Goldenberg DL,
    2. Burckhardt C,
    3. Crofford L
    . Management of fibromyalgia syndrome. JAMA 2004;292:2388–95.
    OpenUrlCrossRefPubMed
  10. 10.↵
    1. Chu LF,
    2. Clark DJ,
    3. Angst MS
    . Opioid tolerance and hyperalgesia in chronic pain patients after one month of oral morphine therapy: a preliminary prospective study. J Pain 2006;7:43–8.
    OpenUrlCrossRefPubMed
  11. 11.↵
    1. Gendreau RM,
    2. Thorn MD,
    3. Gendreau JF,
    4. et al
    . Efficacy of milnacipran in patients with fibromyalgia. J Rheumatol 2005;32:1975–85.
    OpenUrlAbstract/FREE Full Text
  12. 12.↵
    1. Clauw DJ,
    2. Mease P,
    3. Palmer RH,
    4. Gendreau RM,
    5. Wang Y
    . Milnacipran for the treatment of fibromyalgia in adults: a 15-week, multicenter, randomized, double-blind, placebo-controlled, multiple-dose clinical trial. Clin Ther 2008;30:1988–2004.
    OpenUrlCrossRefPubMed
  13. 13.↵
    1. Branco JC,
    2. Perrot S,
    3. Bragee G,
    4. Zacchrisson O,
    5. Mikkelsen K,
    6. Mainguy Y
    . Milnacipran for the treatment of fibromyalgia syndrome: a European multicenter, randomized, double-blind, placebo-controlled trial [abstract]. Ann Rheum Dis 2008;67 Suppl II:251.
    OpenUrlAbstract/FREE Full Text
  14. 14.↵
    1. Vaishnavi SN,
    2. Nemeroff CB,
    3. Plott SJ,
    4. Rao SG,
    5. Kranzler J,
    6. Owens MJ
    . Milnacipran: a comparative analysis of human monoamine uptake and transporter binding affinity. Biol Psychiatry 2004;55:320–2.
    OpenUrlCrossRefPubMed
  15. 15.↵
    1. Dubner R,
    2. Hargreaves KM
    . The neurobiology of pain and its modulation. Clin J Pain 1989;5 Suppl 2S1–4.
    OpenUrlCrossRef
  16. 16.↵
    1. Jones CK,
    2. Eastwood BJ,
    3. Need AB,
    4. Shannon HE
    . Analgesic effects of serotonergic, noradrenergic or dual reuptake inhibitors in the carrageenan test in rats: evidence for synergism between serotonergic and noradrenergic reuptake inhibition. Neuropharmacology 2006;51:1172–80.
    OpenUrlCrossRefPubMed
  17. 17.↵
    1. Mochizucki D
    . Serotonin and noradrenaline reuptake inhibitors in animal models of pain. Hum Psychopharmacol 2004;19 Suppl 1S15–9.
    OpenUrlCrossRefPubMed
  18. 18.↵
    1. Russell IJ,
    2. Vaeroy H,
    3. Javors M,
    4. Nyberg F
    . Cerebrospinal fluid biogenic amine metabolites in fibromyalgia/fibrositis syndrome and rheumatoid arthritis. Arthritis Rheum 1992;35:550–6.
    OpenUrlCrossRefPubMed
  19. 19.↵
    1. Stahl SM
    . The psychopharmacology of energy and fatigue. J Clin Psychiatry 2002;63:7–8.
    OpenUrlCrossRefPubMed
  20. 20.↵
    1. Stahl SM
    . Neurotransmission of cognition, part 1, Dopamine is a hitchhiker in frontal cortex: norepinephrine transporters regulate dopamine. J Clin Psychiatry 2003;64:4–5.
    OpenUrlPubMed
  21. 21.↵
    1. Moret C,
    2. Charveron M,
    3. Finberg JP,
    4. Couzinier JP,
    5. Briley M
    . Biochemical profile of midalcipran (F 2207), 1-phenyl-1-diethyl-aminocarbonyl-2-aminomethyl-cyclopropane (Z) hydrochloride, a potential fourth generation antidepressant drug. Neuropharmacology 1985;24:1211–9.
    OpenUrlCrossRefPubMed
  22. 22.↵
    1. Max MB,
    2. Lynch SA,
    3. Muir J,
    4. Shoaf SE,
    5. Smoller B,
    6. Dubner R
    . Effects of desipramine, amitriptyline, and fluoxetine on pain in diabetic neuropathy. N Engl J Med 1992;326:1250–6.
    OpenUrlPubMed
  23. 23.
    1. Atkinson JH,
    2. Slater MA,
    3. Capparelli EV,
    4. et al
    . Efficacy of noradrenergic and serotonergic antidepressants in chronic back pain: a preliminary concentration-controlled trial. J Clin Psychopharmacol 2007;27:135–42.
    OpenUrlCrossRefPubMed
  24. 24.↵
    1. Atkinson JH,
    2. Slater MA,
    3. Wahlgren DR,
    4. et al
    . Effects of noradrenergic and serotonergic antidepressants on chronic low back pain intensity. Pain 1999;83:137–45.
    OpenUrlCrossRefPubMed
  25. 25.↵
    1. Lecrubier Y
    . Milnacipran: the clinical properties of a selective serotonin and noradrenaline reuptake inhibitor. Hum Psychopharmacol 1997;12:S127–S34.
    OpenUrl
  26. 26.↵
    1. Puozzo C,
    2. Lens S,
    3. Reh C,
    4. et al
    . Lack of interaction of milnacipran with the cytochrome P450 isoenzymes frequently involved in the metabolism of antidepressants. Clin Pharmacokinet 2005;44:977–88.
    OpenUrlCrossRefPubMed
  27. 27.↵
    1. Vitton O,
    2. Gendreau M,
    3. Gendreau J,
    4. Kranzler J,
    5. Rao SG
    . A double-blind placebo-controlled trial of milnacipran in the treatment of fibromyalgia. Hum Psychopharmacol 2004;19 Suppl 1S27–35.
    OpenUrlCrossRefPubMed
  28. 28.↵
    1. Nagaoka S,
    2. Ohno M,
    3. Sekiguchi A
    . An open-label clinical trial of milnacipran in fibromyalgia syndrome with co-morbid depressive symptoms. Int J Psychiatry Clin Pract 2004;8:47–51.
    OpenUrlCrossRef
  29. 29.
    1. Kamata M,
    2. Takahashi H,
    3. Naito S,
    4. Higuchi H
    . Effectiveness of milnacipran for the treatment of chronic pain: a case series. Clin Neuropharmacol 2004;27:208–10.
    OpenUrlCrossRefPubMed
  30. 30.
    1. Briley M
    . Clinical experience with dual action antidepressants in different chronic pain syndromes. Hum Psychopharmacol 2004;19 Suppl 1S21–5.
    OpenUrlCrossRefPubMed
  31. 31.↵
    1. Kito S,
    2. Nakajima T,
    3. Koga Y
    . Milnacipran for the drastic improvement of refractory pain in a patient without depressive symptoms: a case report. Eur Psychiatry 2005;20:355.
    OpenUrlPubMed
  32. 32.↵
    1. Sheehan DV,
    2. Lecrubier Y,
    3. Sheehan KH,
    4. et al
    . The Mini-International Neuropsychiatric Interview (MINI): the development and validation of a structured diagnostic psychiatric interview for DSM-IV and ICD-10. J Clin Psychiatry 1998;59 Suppl 2022–33.
    OpenUrlPubMed
  33. 33.↵
    1. Ware JE,
    2. Kosinski M,
    3. Keller SK
    . SF-36 physical and mental health summary scales: a user’s manual. Boston: The Health Institute; 1994.
  34. 34.↵
    1. Burckhardt CS,
    2. Clark SR,
    3. Bennett RM
    . The Fibromyalgia Impact Questionnaire: development and validation. J Rheumatol 1991;18:728–33.
    OpenUrlPubMed
  35. 35.
    1. Smets EM,
    2. Garssen B,
    3. Bonke B,
    4. De Haes JC
    . The Multidimensional Fatigue Inventory (MFI): psychometric qualities of an instrument to assess fatigue. J Psychosom Res 1995;39:315–25.
    OpenUrlCrossRefPubMed
  36. 36.
    1. Beck AT,
    2. Ward CH,
    3. Mendelson M,
    4. Mock J,
    5. Erbaugh J
    . An inventory for measuring depression. Arch Gen Psychiatry 1961;4:561–71.
    OpenUrlCrossRefPubMed
  37. 37.
    1. Hays RD
    . Sleep measures. Durham, NC: University Press; 1992.
  38. 38.
    1. Hays RD,
    2. Martin SA,
    3. Sesti AM,
    4. Spritzer KL
    . Psychometric properties of the Medical Outcomes Study sleep measure. Sleep Med 2005;6:41–4.
    OpenUrlCrossRefPubMed
  39. 39.
    1. Pincus T,
    2. Swearingen C,
    3. Wolfe F
    . Toward a multidimensional Health Assessment Questionnaire (MDHAQ): assessment of advanced activities of daily living and psychological status in the patient-friendly health assessment questionnaire format. Arthritis Rheum 1999;42:2220–30.
    OpenUrlCrossRefPubMed
  40. 40.
    1. Seidenberg M,
    2. Haltiner A,
    3. Taylor MA,
    4. Hermann BB,
    5. Wyler A
    . Development and validation of a Multiple Ability Self-Report Questionnaire. J Clin Exp Neuropsychol 1994;16:93–104.
    OpenUrlPubMed
  41. 41.↵
    1. McGahuey CA,
    2. Gelenberg AJ,
    3. Laukes CA,
    4. et al
    . The Arizona Sexual Experience Scale (ASEX): reliability and validity. J Sex Marital Ther 2000;26:25–40.
    OpenUrlCrossRefPubMed
  42. 42.↵
    1. Farrar JT,
    2. Young JP, Jr,
    3. LaMoreaux L,
    4. Werth JL,
    5. Poole RM
    . Clinical importance of changes in chronic pain intensity measured on an 11-point numerical pain rating scale. Pain 2001;94:149–58.
    OpenUrlCrossRefPubMed
  43. 43.↵
    1. Dworkin RH,
    2. Turk DC,
    3. Wyrwich KW,
    4. et al
    . Interpreting the clinical importance of treatment outcomes in chronic pain clinical trials: IMMPACT recommendations. J Pain 2008;9:105–21.
    OpenUrlCrossRefPubMed
  44. 44.↵
    1. Thumboo J,
    2. Fong KY,
    3. Chan SP,
    4. et al
    . A prospective study of factors affecting quality of life in systemic lupus erythematosus. J Rheumatol 2000;27:1414–20.
    OpenUrlPubMed
  45. 45.
    1. Beaton DE,
    2. Boers M,
    3. Wells GA
    . Many faces of the minimal clinically important difference: a literature review and directions for future research. Curr Opin Rheumatol 2002;14:109–14.
    OpenUrlCrossRefPubMed
  46. 46.
    1. Strand V,
    2. Scott DL,
    3. Emery P,
    4. et al
    . Physical function and health related quality of life: analysis of 2-year data from randomized, controlled studies of leflunomide, sulfasalazine, or methotrexate in patients with active rheumatoid arthritis. J Rheumatol 2005;32:590–601.
    OpenUrlAbstract/FREE Full Text
  47. 47.
    1. Strand V
    . Longer term benefits of treating rheumatoid arthritis: assessment of radiographic damage and physical function in clinical trials. Clin Exp Rheumatol 2004;22:S57–64.
    OpenUrlPubMed
  48. 48.
    1. Angst F,
    2. Aeschlimann A,
    3. Stucki G
    . Smallest detectable and minimal clinically important differences of rehabilitation intervention with their implications for required sample sizes using WOMAC and SF-36 quality of life measurement instruments in patients with osteoarthritis of the lower extremities. Arthritis Rheum 2001;45:384–91.
    OpenUrlCrossRefPubMed
  49. 49.
    1. Strand V,
    2. Kelman A
    . Outcome measures in osteoarthritis: randomized controlled trials. Curr Rheumatol Rep 2004;6:20–30.
    OpenUrlPubMed
  50. 50.↵
    1. Stucki G,
    2. Ewert T
    . How to assess the impact of arthritis on the individual patient: the WHO ICF. Ann Rheum Dis 2005;64:664–8.
    OpenUrlAbstract/FREE Full Text
  51. 51.↵
    1. Mease P,
    2. Arnold LM,
    3. Bennett R,
    4. et al
    . Fibromyalgia syndrome. J Rheumatol 2007;34:1415–25.
    OpenUrlAbstract/FREE Full Text
  52. 52.↵
    1. Arnold LM,
    2. Rosen A,
    3. Pritchett YL,
    4. et al
    . A randomized, double-blind, placebo-controlled trial of duloxetine in the treatment of women with fibromyalgia with or without major depressive disorder. Pain 2005;119:5–15.
    OpenUrlCrossRefPubMed
  53. 53.↵
    1. Russell IJ,
    2. Mease PJ,
    3. Smith TR,
    4. et al
    . Efficacy and safety of duloxetine for treatment of fibromyalgia in patients with or without major depressive disorder: Results from a 6-month, randomized, double-blind, placebo-controlled, fixed-dose trial. Pain 2008;136:432–44.
    OpenUrlCrossRefPubMed
  54. 54.↵
    1. Stahl SM,
    2. Grady MM,
    3. Moret C,
    4. Briley M
    . SNRIs: their pharmacology, clinical efficacy, and tolerability in comparison with other classes of antidepressants. CNS Spectr 2005;10:732–47.
    OpenUrlPubMed
  55. 55.↵
    1. Epstein SA,
    2. Kay G,
    3. Clauw D,
    4. et al
    . Psychiatric disorders in patients with fibromyalgia. A multicenter investigation. Psychosomatics 1999;40:57–63.
    OpenUrlCrossRefPubMed
  56. 56.↵
    1. Arnold LM,
    2. Russell IJ,
    3. Diri EW,
    4. et al
    . A 14-week, randomized, double-blinded, placebo-controlled monotherapy trial of pregabalin in patients with fibromyalgia. J Pain 2008;9:792–805.
    OpenUrlCrossRefPubMed
  57. 57.↵
    1. Mease PJ,
    2. Russell IJ,
    3. Arnold LM,
    4. et al
    . A randomized, double-blind, placebo-controlled, phase III trial of pregabalin in the treatment of patients with fibromyalgia. J Rheumatol 2008;35:502–14.
    OpenUrlAbstract/FREE Full Text
  58. 58.↵
    1. Goldenberg D,
    2. Clauw DJ,
    3. Palmer RH,
    4. Gendreau RM
    . One-year durability of response to milnacipran treatment for fibromyalgia [abstract]. Arthritis Rheum 2007;56 SupplS603.
    OpenUrl
PreviousNext
Back to top

In this issue

The Journal of Rheumatology
Vol. 36, Issue 2
1 Feb 2009
  • Table of Contents
  • Table of Contents (PDF)
  • Index by Author
  • Editorial Board (PDF)
Print
Download PDF
Article Alerts
Sign In to Email Alerts with your Email Address
Email Article

Thank you for your interest in spreading the word about The Journal of Rheumatology.

NOTE: We only request your email address so that the person you are recommending the page to knows that you wanted them to see it, and that it is not junk mail. We do not capture any email address.

Enter multiple addresses on separate lines or separate them with commas.
The Efficacy and Safety of Milnacipran for Treatment of Fibromyalgia. A Randomized, Double-blind, Placebo-controlled Trial
(Your Name) has forwarded a page to you from The Journal of Rheumatology
(Your Name) thought you would like to see this page from the The Journal of Rheumatology web site.
CAPTCHA
This question is for testing whether or not you are a human visitor and to prevent automated spam submissions.
Citation Tools
The Efficacy and Safety of Milnacipran for Treatment of Fibromyalgia. A Randomized, Double-blind, Placebo-controlled Trial
PHILIP J. MEASE, DANIEL J. CLAUW, R. MICHAEL GENDREAU, SRINIVAS G. RAO, JAY KRANZLER, WEI CHEN, ROBERT H. PALMER
The Journal of Rheumatology Feb 2009, 36 (2) 398-409; DOI: 10.3899/jrheum.080734

Citation Manager Formats

  • BibTeX
  • Bookends
  • EasyBib
  • EndNote (tagged)
  • EndNote 8 (xml)
  • Medlars
  • Mendeley
  • Papers
  • RefWorks Tagged
  • Ref Manager
  • RIS
  • Zotero

 Request Permissions

Share
The Efficacy and Safety of Milnacipran for Treatment of Fibromyalgia. A Randomized, Double-blind, Placebo-controlled Trial
PHILIP J. MEASE, DANIEL J. CLAUW, R. MICHAEL GENDREAU, SRINIVAS G. RAO, JAY KRANZLER, WEI CHEN, ROBERT H. PALMER
The Journal of Rheumatology Feb 2009, 36 (2) 398-409; DOI: 10.3899/jrheum.080734
del.icio.us logo Digg logo Reddit logo Twitter logo Facebook logo Google logo Mendeley logo
  • Tweet Widget
  • Facebook Like
  • Google Plus One
Bookmark this article

Jump to section

  • Article
    • Abstract
    • MATERIALS AND METHODS
    • RESULTS
    • DISCUSSION
    • Acknowledgments
    • Footnotes
    • REFERENCES
  • Figures & Data
  • References
  • Info & Metrics
  • PDF
  • eLetters

Related Articles

Cited By...

More in this TOC Section

  • Vasculitis: What Have We Learned in the Last 50 Years?
  • Demographic, Lifestyle, and Serologic Risk Factors for Rheumatoid Arthritis (RA)–associated Bronchiectasis: Role of RA-related Autoantibodies
  • The Association of Illness-related Uncertainty With Mental Health in Systemic Autoimmune Rheumatic Diseases
Show more Article

Similar Articles

Content

  • First Release
  • Current
  • Archives
  • Collections
  • Audiovisual Rheum
  • COVID-19 and Rheumatology

Resources

  • Guide for Authors
  • Submit Manuscript
  • Author Payment
  • Reviewers
  • Advertisers
  • Classified Ads
  • Reprints and Translations
  • Permissions
  • Meetings
  • FAQ
  • Policies

Subscribers

  • Subscription Information
  • Purchase Subscription
  • Your Account
  • Terms and Conditions

More

  • About Us
  • Contact Us
  • My Alerts
  • My Folders
  • Privacy/GDPR Policy
  • RSS Feeds
The Journal of Rheumatology
The content of this site is intended for health care professionals.
Copyright © 2022 by The Journal of Rheumatology Publishing Co. Ltd.
Print ISSN: 0315-162X; Online ISSN: 1499-2752
Powered by HighWire