{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,4,28]],"date-time":"2026-04-28T23:48:24Z","timestamp":1777420104277,"version":"3.51.4"},"reference-count":53,"publisher":"SAGE Publications","issue":"7-8","license":[{"start":{"date-parts":[[2013,6,4]],"date-time":"2013-06-04T00:00:00Z","timestamp":1370304000000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["Ann Pharmacother"],"published-print":{"date-parts":[[2013,7]]},"abstract":"<jats:sec>\n                    <jats:title>BACKGROUND<\/jats:title>\n                    <jats:p>Data from an open-label trial suggest that mirtazapine might prove useful in treatment of fibromyalgia syndrome (FMS).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>OBJECTIVE<\/jats:title>\n                    <jats:p>To obtain preliminary efficacy data of mirtazapine for estimation of sample size requirements for a Phase 2 clinical trial in FMS.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>METHODS<\/jats:title>\n                    <jats:p>This 13-week randomized controlled trial compared the effects of mirtazapine 15 mg\/day, mirtazapine 30 mg\/day, and placebo in 40 patients with FMS. The primary outcomes were change in Pain Visual Analog Scale (PVAS) and proportion of pain responders (\u226530% PVAS reduction). Secondary outcomes included scores from the Jenkins Sleep Scale (JSS), Patient Global Impression of Change (PGIC), Fibromyalgia Impact Questionnaire (FIQ), Hamilton Depression Rating Scale (HAM-D), Patient Global Assessment, and self-reported adverse events.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>RESULTS<\/jats:title>\n                    <jats:p>Significant within-group PVAS reductions from baseline were observed in all 3 groups, with the greatest improvement in the mirtazapine 30-mg group (p &lt; 0.005); between-group difference was not significant. The proportion of pain responders did not meet significance criteria (66.67% for mirtazapine 30 mg, 50% for mirtazapine 15 mg, 41.67% for placebo). Significant within-group improvement in JSS scores was seen for mirtazapine 30 mg (p &lt; 0.01) and mirtazapine 15 mg (p &lt; 0.05). Between-group comparison achieved significance for JSS item 3, waking several times per night (p &lt; 0.05). On the PGIC, 72.73% felt better with both mirtazapine dosages compared with 50% for placebo. Within-group FIQ responses indicated improvement in only mirtazapine-treated groups, whereas within-group improvement for HAM-D and Patient Global Assessment was observed in all groups. Based on our findings, the sample size requirement (80% power, 5% type I error) should be 83 per group to detect PVAS change difference between mirtazapine 30 mg and placebo. Common mirtazapine-related adverse events were increased appetite and weight gain.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>CONCLUSIONS<\/jats:title>\n                    <jats:p>Patients with FMS taking mirtazapine exhibited within-group significant improvement in most of the measured outcomes. Between-group analysis was predictably compromised by the small sample size. Mirtazapine was well tolerated. Further study with a larger sample size is likely to be useful.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1345\/aph.1r725","type":"journal-article","created":{"date-parts":[[2013,6,5]],"date-time":"2013-06-05T01:52:55Z","timestamp":1370397175000},"page":"921-932","update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":22,"title":["Efficacy and Safety of Mirtazapine in Fibromyalgia Syndrome Patients: A Randomized Placebo-Controlled Pilot Study"],"prefix":"10.1177","volume":"47","author":[{"given":"Suwimon","family":"Yeephu","sequence":"first","affiliation":[{"name":"Suwimon Yeephu BPharm MSc (clinical pharmacy), PhD Candidate; Assistant Professor, Faculty of Pharmacy, Department of Pharmacology, Mahidol University, Rajthevee, Bangkok, Thailand"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Chuthamanee","family":"Suthisisang","sequence":"additional","affiliation":[{"name":"Chuthamanee Suthisisang 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