{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,12,2]],"date-time":"2025-12-02T22:37:45Z","timestamp":1764715065571,"version":"3.41.2"},"reference-count":28,"publisher":"Wiley","issue":"3","license":[{"start":{"date-parts":[[2022,2,9]],"date-time":"2022-02-09T00:00:00Z","timestamp":1644364800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100006546","name":"Angelini Pharma","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100006546","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Brain and Behavior"],"published-print":{"date-parts":[[2022,3]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Aim<\/jats:title><jats:p>The effect of switching from lithium immediate release (Li\u2010IR) to lithium prolonged release (Li\u2010PR) on lithium\u2010induced tremor after 1 and 12\u00a0weeks of treatment was evaluated in a randomized, multicenter, open trial, in bipolar patients from the participating sites with a tremor severity \u22652 (Udvalg for Kliniske Unders\u00f8gelser [UKU] rating scale) despite optimal lithium titration.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>The primary endpoint was the evaluation of tremor by means of the UKU scale after 1 week of treatment. Secondary endpoints included manic Young Mania Rating Scale (YMRS) and depressive symptoms (Montgomery\u2013Asberg Depression Rating Scale), a global assessment of the patient's status (Clinical Global Impression), polyuria\/polydipsia (UKU item 3.8) and patient\u2010reported outcomes.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Owing to difficulties in including suitable patients the enrollment phase was closed when 73 patients were randomized. Notwithstanding the lower number of patients, in the modified intention\u2010to\u2010treat population (<jats:italic>n<\/jats:italic>\u00a0=\u00a070) the primary endpoint was statistically significant: tremor improved after 1 week in 62.9% in Li\u2010PR group against 20.0% of patients in Li\u2010IR group (<jats:italic>p<\/jats:italic>\u00a0=\u00a0.0006; two\u2010tailed Fisher's exact test). The difference remained statistically significant after 4 (<jats:italic>p<\/jats:italic>\u00a0=\u00a0.0031) and 12\u00a0weeks (<jats:italic>p<\/jats:italic>\u00a0=\u00a0.0128). The same analysis performed in the PP population confirmed these results. Among the secondary endpoints, only the factor convenience of the treatment satisfaction questionnaire showed a statistically significant difference between groups. There were no apparent differences in the safety profile of the two formulations.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>This study is the first comparative documentation of a potential benefit of the prolonged\u2010release formulation in reducing the symptom tremor, a well\u2010known adverse effect of lithium therapy. Indeed, the study results should be interpreted taking into account the sample size lower than planned.<\/jats:p><\/jats:sec>","DOI":"10.1002\/brb3.2485","type":"journal-article","created":{"date-parts":[[2022,2,9]],"date-time":"2022-02-09T08:50:22Z","timestamp":1644396622000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":10,"title":["Clinical evaluation of switching from immediate\u2010release to prolonged\u2010release lithium in bipolar patients, poorly tolerant to\u00a0lithium immediate\u2010release treatment: A randomized clinical\u00a0trial"],"prefix":"10.1002","volume":"12","author":[{"given":"Federica","family":"Pelacchi","sequence":"first","affiliation":[{"name":"Global Medical Department, Angelini Pharma S.p.A.  Rome Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Liliana","family":"Dell'Osso","sequence":"additional","affiliation":[{"name":"Department of Clinical and Experimental Medicine University of Pisa  Pisa Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Emi","family":"Bondi","sequence":"additional","affiliation":[{"name":"Psychiatric Service Diagnosis and Care Papa Giovanni XXIII Hospital  Bergamo Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Mario","family":"Amore","sequence":"additional","affiliation":[{"name":"Institute of Rehabilitation and Care for Scientific Character San Martino Polyclinic Hospital University Psychiatric Clinic  Genova Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Andrea","family":"Fagiolini","sequence":"additional","affiliation":[{"name":"Psychiatry University\u2010Hospital of Siena  Siena Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Paolo","family":"Iazzetta","sequence":"additional","affiliation":[{"name":"Functional Unit Mental Health Adults San Giovanni di Dio Hospital  Orbetello\u2010Grosseto Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Daniela","family":"Pierucci","sequence":"additional","affiliation":[{"name":"Global Medical Department, Angelini Pharma S.p.A.  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