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A randomized, double-blind, placebo-controlled trial to assess prevention of mood episodes with risperidone long-acting injectable in patients with bipolar I disorder

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dc.creatorVieta, Eduardspa
dc.creatorMontgomery, Stuartspa
dc.creatorHatim Sulaiman, Ahmadspa
dc.creatorCordoba Rojas, Rodrigo Nel
dc.creatorHuberlant, Benedictespa
dc.creatorMartinez, Lupespa
dc.creatorSchreiner, Andreasspa
dc.date.accessioned2020-08-06T16:21:32Z
dc.date.available2020-08-06T16:21:32Z
dc.date.created2012-11spa
dc.description.abstractThe efficacy and safety of risperidone long-acting injectable (LAI) for preventing recurrence of mood episodes in patients with bipolar I disorder was evaluated in a randomized, placebo-controlled study. After a 12-week open-label period with risperidone LAI (n=560), patients who did not experience a recurrence entered an 18-month randomized, double-blind period with risperidone LAI (n=132) or placebo (n=135); a third treatment arm (n=131) was randomized to oral olanzapine (10 mg/day) for reference and exploratory comparisons. The primary efficacy endpoint was time to recurrence of any mood episode for risperidone LAI versus placebo in the double-blind period (Kaplan–Meier analysis). Additional efficacy endpoints included Young Mania Rating Scale, Montgomery–Asberg Depression Rating Scale and Clinical Global Impression. During the double-blind period, dosing was fixed at patients' final open-label dose (25 mg, 66% of patients; 37.5 mg, 31%; 50 mg, 4%). The primary outcome demonstrated a median time to mood episode recurrence of 198 day in the placebo arm, whereas the median was not reached in the risperidone LAI arm (p=0.057). Time to recurrence of any mood episode was significantly longer with risperidone LAI versus placebo (log-rank test stratified by region only, p=0.031); the difference was significant for time to recurrence of elevated mood episodes (p=0.005) but not depressive episodes (p=0.655). Significant improvement of manic symptoms and global condition versus placebo were observed for risperidone LAI, with no evidence of worsening of depression. In conclusion, risperidone LAI significantly delayed time to recurrence of elevated mood episodes, with a safety profile consistent with previous studies.eng
dc.format.mimetypeapplication/pdf
dc.identifier.doihttps://doi.org/10.1016/j.euroneuro.2012.03.004
dc.identifier.issnISSN: 0924-977X
dc.identifier.urihttps://repository.urosario.edu.co/handle/10336/26389
dc.language.isoengspa
dc.publisherElsevierspa
dc.relation.citationEndPage835
dc.relation.citationIssueNo. 11
dc.relation.citationStartPage825
dc.relation.citationTitleEuropean Neuropsychopharmacology
dc.relation.citationVolumeVol. 22
dc.relation.ispartofEuropean Neuropsychopharmacology, ISSN: 0924-977X, Vol.22, No.11 (November, 2012); pp.825-835spa
dc.relation.urihttps://www.sciencedirect.com/science/article/abs/pii/S0924977X12000600?via%3Dihub#!spa
dc.rights.accesRightsinfo:eu-repo/semantics/openAccess
dc.rights.accesoAbierto (Texto Completo)spa
dc.sourceEuropean Neuropsychopharmacologyspa
dc.source.instnameinstname:Universidad del Rosario
dc.source.reponamereponame:Repositorio Institucional EdocUR
dc.subject.keywordAtypical antipsychoticsspa
dc.subject.keywordBipolar disorderspa
dc.subject.keywordLong-acting injectablespa
dc.subject.keywordPlacebo-controlled trialspa
dc.subject.keywordRecurrencespa
dc.subject.keywordRisperidonespa
dc.titleA randomized, double-blind, placebo-controlled trial to assess prevention of mood episodes with risperidone long-acting injectable in patients with bipolar I disorderspa
dc.title.TranslatedTitleUn ensayo aleatorizado, doble ciego, controlado con placebo para evaluar la prevención de episodios del estado de ánimo con risperidona inyectable de acción prolongada en pacientes con trastorno bipolar Ispa
dc.typearticleeng
dc.type.hasVersioninfo:eu-repo/semantics/publishedVersion
dc.type.spaArtículospa
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