Effects of asenapine on depressive symptoms in patients with bipolar I disorder experiencing acute manic or mixed episodes a post hoc analysis of two 3-week clinical trials.docVIP

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Effects of asenapine on depressive symptoms in patients with bipolar I disorder experiencing acute manic or mixed episodes a post hoc analysis of two 3-week clinical trials.doc

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Effects of asenapine on depressive symptoms in patients with bipolar I disorder experiencing acute manic or mixed episodes a post hoc analysis of two 3-week clinical trials

Szegedietal.BMCPsychiatry2011,11:101 /1471-244X/11/101 RESEARCH ARTICLE OpenAccess Effectsofasenapineondepressivesymptomsin patientswithbipolarIdisorderexperiencing acutemanicormixedepisodes:aposthoc analysisoftwo3-weekclinicaltrials ArminSzegedi1*,JunZhao1,ArjenvanWilligenburg2,KariRNations1,MaryMackle1andJohnPanagides3 Abstract Background:AsenapinedemonstratedsuperiorityoverplaceboformaniainbipolarIdisorderpatients experiencingacutecurrentmanicormixedepisodesin2randomized,placebo-andolanzapine-controlledtrials.We reporttheresultsofexploratorypooledposthocanalysesfromthesetrialsevaluatingasenapine’seffectson depressivesymptomsinpatientsfromthesetrialswithsignificantbaselinedepressivesymptoms. Methods:Intheoriginaltrials(A7501004[NC,A7501005[NC),977patientswererandomized toflexible-dosesublingualasenapine(10mgtwicedailyonday1;5or10mgtwicedailythereafter),placebo,or oralolanzapine5-20mgoncedailyfor3weeks.Threepopulationsweredefinedusingbaselinedepressive symptoms:(1)Montgomery-AsbergDepressionRatingScale(MADRS)totalscore≥20(n=132);(2)ClinicalGlobal ImpressionforBipolarDisorder-Depression(CGI-BP-D)scaleseverityscore≥4(n=170);(3)diagnosisofmixed episodes(n=302)byinvestigativesitescreening.Foreachpopulation,asenapineandolanzapinewere independentlycomparedwithplacebousingleastsquaresmeanchangefrombaselineondepressivesymptom measures. Results:DecreasesinMADRStotalscorewerestatisticallygreaterwithasenapineversusplaceboatdays7and21 inallpopulations;differencesbetweenolanzapineandplacebowerenotsignificant.DecreasesinCGI-BP-Dscore weresignificantlygreaterwithasenapineversusplaceboatday7inallcategoriesandday21inpopulation1;CGI- BP-Dscorereductionsweresignificantlygreaterwitholanzapineversusplaceboatday21inpopulation1andday 7inpopulations2and3. Conclusions:TheseposthocanalysesshowthatasenapinereduceddepressivesymptomsinbipolarIdisorder patientsexperiencingacutemanicormixedepisodeswithclinicallyrelevantdepressivesymptomsatbaseline; olanzapineresultsappeare