{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,9,29]],"date-time":"2025-09-29T08:18:27Z","timestamp":1759133907477},"reference-count":51,"publisher":"Springer Science and Business Media LLC","issue":"1","license":[{"start":{"date-parts":[[2013,2,27]],"date-time":"2013-02-27T00:00:00Z","timestamp":1361923200000},"content-version":"unspecified","delay-in-days":0,"URL":"http:\/\/www.springer.com\/tdm"}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["BMC Psychiatry"],"published-print":{"date-parts":[[2013,12]]},"abstract":"<jats:title>Abstract<\/jats:title>\n          <jats:sec>\n            <jats:title>Background<\/jats:title>\n            <jats:p>Treatment of patients with acute mania remains a considerable medical challenge since onset of action of antimanic medication is delayed for several days. Psychostimulants could have an earlier onset of action. This assumption is based on the \u2018vigilance regulation model of mania\u2019 which postulates that vigilance is unstable in manic patients. Accordingly, vigilance-stabilising psychostimulants could be more useful than conventional treatment in acute mania. We present here the study protocol of a trial intended to study the efficacy and safety of methylphenidate in the initial treatment of acute mania.<\/jats:p>\n          <\/jats:sec>\n          <jats:sec>\n            <jats:title>Methods\/design<\/jats:title>\n            <jats:p>A multi-centre, randomised, double-blind, placebo-controlled clinical trial will be conducted in 88 bipolar inpatients with acute mania. Male and female patients older than 18\u2009years will be randomised to treatment with either methylphenidate (20 to 40\u2009mg\/day) or placebo for 2.5\u2009days, given once or twice daily. The main outcome measure is the reduction in the Young Mania Rating Scale (YMRS) after 2.5\u2009days of treatment. Other outcome measures include the Positive and Negative Syndrome Scale-Excited Component (PANSS-EC) the Clinical Global Impression\u2013Bipolar Scale (CGI-BP), the Screen for Cognitive Impairment in Psychiatry (SCIP), actigraphy and the EEG-\u2018Vigilance Algorithm Leipzig\u2019 (VIGALL).<\/jats:p>\n          <\/jats:sec>\n          <jats:sec>\n            <jats:title>Discussion<\/jats:title>\n            <jats:p>A positive study outcome of the proposed study could substantially impact our understanding of the etiopathogenesis of mania and open new treatment perspectives.<\/jats:p>\n          <\/jats:sec>\n          <jats:sec>\n            <jats:title>Trial registration<\/jats:title>\n            <jats:p>ClinicalTrials.gov:<jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" xlink:href=\"http:\/\/www.clinicaltrials.gov\/NCT01541605\" ext-link-type=\"uri\">NCT01541605<\/jats:ext-link>\n            <\/jats:p>\n          <\/jats:sec>","DOI":"10.1186\/1471-244x-13-71","type":"journal-article","created":{"date-parts":[[2013,2,27]],"date-time":"2013-02-27T23:14:14Z","timestamp":1362006854000},"update-policy":"http:\/\/dx.doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":14,"title":["Methylphenidate in mania project (MEMAP): study protocol of an international randomised double-blind placebo-controlled study on the initial treatment of acute mania with methylphenidate"],"prefix":"10.1186","volume":"13","author":[{"given":"Michael","family":"Kluge","sequence":"first","affiliation":[]},{"given":"Ulrich","family":"Hegerl","sequence":"additional","affiliation":[]},{"given":"Christian","family":"Sander","sequence":"additional","affiliation":[]},{"given":"Jens","family":"Dietzel","sequence":"additional","affiliation":[]},{"given":"Roland","family":"Mergl","sequence":"additional","affiliation":[]},{"given":"Istvan","family":"Bitter","sequence":"additional","affiliation":[]},{"given":"Koen","family":"Demyttenaere","sequence":"additional","affiliation":[]},{"given":"Ricardo","family":"Gusm\u00e3o","sequence":"additional","affiliation":[]},{"given":"Ana","family":"Gonzalez-Pinto","sequence":"additional","affiliation":[]},{"given":"Victor","family":"Perez-Sola","sequence":"additional","affiliation":[]},{"given":"Eduard","family":"Vieta","sequence":"additional","affiliation":[]},{"given":"Georg","family":"Juckel","sequence":"additional","affiliation":[]},{"given":"Ulrich S","family":"Zimmermann","sequence":"additional","affiliation":[]},{"given":"Michael","family":"Bauer","sequence":"additional","affiliation":[]},{"given":"Pascal","family":"Sienaert","sequence":"additional","affiliation":[]},{"given":"S\u00f3nia","family":"Quint\u00e3o","sequence":"additional","affiliation":[]},{"given":"Marc-Andreas","family":"Edel","sequence":"additional","affiliation":[]},{"given":"Csilla","family":"Bolyos","sequence":"additional","affiliation":[]},{"given":"Jose Luis","family":"Ayuso-Mateos","sequence":"additional","affiliation":[]},{"given":"Pilar","family":"L\u00f3pez-Garc\u00eda","sequence":"additional","affiliation":[]}],"member":"297","published-online":{"date-parts":[[2013,2,27]]},"reference":[{"issue":"Suppl 13","key":"1226_CR1","first-page":"13","volume":"57","author":"PE Keck Jr","year":"1996","unstructured":"Keck PE, McElroy SL, Bennett JA: Health-economic implications of the onset of action of antimanic agents. 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