{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,7]],"date-time":"2026-10-07T07:17:26Z","timestamp":1791357446152,"version":"4.3.1"},"reference-count":32,"publisher":"The Journal of Rheumatology","issue":"7","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["J Rheumatol"],"published-print":{"date-parts":[[2015,7]]},"abstract":"<jats:sec><jats:title>Objective.<\/jats:title><jats:p>To assess pregabalin efficacy and safety in patients with fibromyalgia (FM) with comorbid depression taking concurrent antidepressant medication.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods.<\/jats:title><jats:p>This randomized, placebo-controlled, double-blind, 2-period, 2-way crossover study was composed of two 6-week treatment periods separated by a 2-week taper\/washout phase. Patients with FM (aged \u2265 18 yrs) taking a stable dose of a selective serotonin reuptake inhibitor (SSRI) or a serotonin\/norepinephrine reuptake inhibitor (SNRI) for depression were randomized 1:1 to receive pregabalin\/placebo or placebo\/pregabalin (optimized to 300 or 450 mg\/day). Antidepressant medication was continued throughout the study. The primary efficacy outcome was the mean pain score on an 11-point numerical rating scale. Secondary efficacy outcomes included measures of anxiety, depression, patient function, and sleep.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results.<\/jats:title><jats:p>Of 197 patients randomized to treatment, 181 and 177 received \u2265 1 dose of pregabalin and placebo, respectively. At baseline, 52.3% of patients were taking an SSRI and 47.7% an SNRI, and mean pain score was 6.7. Mean pain scores at endpoint were statistically significantly reduced with pregabalin (least squares mean difference from placebo \u22120.61, 95% CI \u22120.91 \u2013 \u22120.31, p = 0.0001). Pregabalin significantly improved Hospital Anxiety and Depression Scale-Anxiety (difference \u22120.95, p &lt; 0.0001) and -Depression (difference \u22120.88, p = 0.0005) scores, Fibromyalgia Impact Questionnaire total score (difference \u22126.60, p &lt; 0.0001), and sleep quality (difference 0.57, p &lt; 0.0001), but not EuroQol 5-Dimensions score (difference 0.02, p = 0.3854). Pregabalin safety was consistent with previous studies and current product labeling.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion.<\/jats:title><jats:p>Compared with placebo, pregabalin statistically significantly improved FM pain and other symptoms in patients taking antidepressant medication for comorbid depression. <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" xlink:href=\"ClinicalTrials.gov\" ext-link-type=\"uri\" xlink:type=\"simple\">ClinicalTrials.gov<\/jats:ext-link> identifier: <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"clintrialgov\" xlink:href=\"NCT01432236\">NCT01432236<\/jats:ext-link>.<\/jats:p><\/jats:sec>","DOI":"10.3899\/jrheum.141196","type":"journal-article","created":{"date-parts":[[2015,6,2]],"date-time":"2015-06-02T13:47:45Z","timestamp":1433252865000},"page":"1237-1244","source":"Crossref","is-referenced-by-count":39,"title":["Efficacy and Safety of Pregabalin in Patients with Fibromyalgia and Comorbid Depression Taking Concurrent Antidepressant Medication: A Randomized, Placebo-controlled Study"],"prefix":"10.3899","volume":"42","author":[{"given":"Lesley M.","family":"Arnold","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Piercarlo","family":"Sarzi-Puttini","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Pierre","family":"Arsenault","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tahira","family":"Khan","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Pritha","family":"Bhadra Brown","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Andrew","family":"Clair","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Joseph M.","family":"Scavone","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Joseph","family":"Driscoll","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jaren","family":"Landen","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lynne","family":"Pauer","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"2262","published-online":{"date-parts":[[2015,6,1]]},"reference":[{"key":"2018112909342562000_42.7.1237.1","doi-asserted-by":"publisher","DOI":"10.1002\/art.1780380104"},{"key":"2018112909342562000_42.7.1237.2","doi-asserted-by":"publisher","DOI":"10.1002\/art.23176"},{"key":"2018112909342562000_42.7.1237.3","doi-asserted-by":"publisher","DOI":"10.1002\/art.1780330203"},{"key":"2018112909342562000_42.7.1237.4","doi-asserted-by":"publisher","DOI":"10.1001\/archinte.160.2.221"},{"key":"2018112909342562000_42.7.1237.5","doi-asserted-by":"publisher","DOI":"10.1002\/art.23826"},{"key":"2018112909342562000_42.7.1237.6","doi-asserted-by":"publisher","DOI":"10.1016\/S0033-3182(99)71272-7"},{"key":"2018112909342562000_42.7.1237.7","doi-asserted-by":"publisher","DOI":"10.4088\/JCP.v67n0807"},{"key":"2018112909342562000_42.7.1237.8","doi-asserted-by":"publisher","DOI":"10.1007\/s00296-010-1713-x"},{"key":"2018112909342562000_42.7.1237.9","unstructured":"Pfizer Inc . 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