53950
document
A randomized , placebo- and active-controlled study of paliperidone extended-release as maintenance treatment in patients with bipolar I disorder after an acute manic or mixed episode . BACKGROUND Paliperidone ER monotherapy was efficacious in treating acute mania in two 3-week studies in patients with bipolar I disorder . We assessed its efficacy in a study investigating maintenance treatment of clinically stable patients with this disorder . METHODS Patients ( n=766 ) , aged 18 to 65 years inclusive , with current manic or mixed episodes were initially randomized ( 4:1 ) to flexibly-dosed paliperidone ER ( 3-12 mg/day ) or olanzapine ( 5-20 mg/day ; 3-week acute treatment phase ) ; responders continued the same treatment ( 12-week continuation phase ) . Patients on paliperidone ER who achieved remission during this phase were randomized ( 1:1 ) to fixed-dose paliperidone ER ( n=152 ) or placebo ( n=148 ) ; those on olanzapine continued to receive that at fixed dose ( n=83 ) ( maintenance phase ) . RESULTS Median time to recurrence of any mood symptoms ( primary endpoint ) was : 558 days ( paliperidone ER ) , 283 days ( placebo ) and not observed with olanzapine ( < 50 % of patients experienced recurrence ) . Time to recurrence of any mood symptoms was significantly longer with paliperidone ER than placebo ( p=0.017 ; based on weighted Z-test at 0.0198 significance level ; hazard ratio [ placebo : paliperidone ER ; unweighted 95 % confidence interval ] : 1.43 [ 1.03 ; 1.98 ] ) ; the difference was significant for preventing recurrence of manic , but not depressive , symptoms . Treatment-emergent adverse events ( maintenance phase ) occurred more often in olanzapine group ( 64 % ) than placebo ( 59 % ) or paliperidone ER groups ( 55 % ) . LIMITATIONS Responder-enriched design prevents extrapolation of data to patients not previously stabilized on paliperidone ER . CONCLUSIONS Paliperidone ER significantly delayed the time to recurrence of any mood symptoms , versus placebo , in patients with bipolar I disorder . No new safety concerns emerged .
53951
Intervention_Control
placebo-
53952
Intervention_Pharmacological
paliperidone
53953
Intervention_Pharmacological
Paliperidone ER monotherapy
53954
Intervention_Pharmacological
paliperidone ER
53955
Intervention_Pharmacological
olanzapine
53956
Intervention_Pharmacological
paliperidone ER
53957
Intervention_Pharmacological
paliperidone ER
53958
Intervention_Control
placebo
53959
Intervention_Pharmacological
olanzapine
53960
Intervention_Pharmacological
paliperidone ER
53961
Intervention_Control
placebo
53962
Intervention_Pharmacological
olanzapine
53963
Intervention_Pharmacological
paliperidone ER
53964
Intervention_Pharmacological
olanzapine
53965
Intervention_Control
placebo
53966
Intervention_Pharmacological
paliperidone ER
53967
Intervention_Pharmacological
paliperidone ER
53968
Intervention_Pharmacological
Paliperidone ER
53969
Intervention_Control
placebo
53970
Outcome_Mental
Median time to recurrence of any mood symptoms ( primary endpoint )
53971
Outcome_Mental
Time to recurrence of any mood symptoms
53972
Outcome_Mental
recurrence of manic
53973
Outcome_Adverse-effects
Treatment-emergent adverse events ( maintenance phase )
53974
Participant_Condition
bipolar I disorder
53975
Participant_Condition
acute manic or mixed episode
53976
Participant_Condition
bipolar I disorder
53977
Participant_Condition
clinically stable
53978
Participant_Sample-size
n=766
53979
Participant_Age
18 to 65 years
53980
Participant_Condition
current manic or mixed episodes
53981
Participant_Condition
bipolar I disorder