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document
Maintenance of response following stabilization of mixed index episodes with olanzapine monotherapy in a randomized , double-blind , placebo-controlled study of bipolar 1 disorder . BACKGROUND In a population of patients with manic and mixed mood episodes , olanzapine has proven effective in maintaining response , as compared to placebo . Whether this is true for the subpopulation of patients with a mixed index episode is not known . METHODS Post-hoc analyses were conducted on data from patients presenting with a mixed index episode who were enrolled in a larger double-blind , placebo-controlled trial . Patients who met remission criteria at 2 consecutive weekly visits during 6 to 12 weeks of open-label olanzapine treatment were randomly assigned to olanzapine or placebo treatment for 48 weeks . The incidence of and time to symptomatic relapse were calculated for any mood episode , and for depressive , manic , hypo-manic , and mixed mood episodes . RESULTS A total of 121 of 304 patients ( 39.8 % ) met criteria for symptomatic remission in the open-label treatment phase and were randomly assigned to olanzapine ( n=76 ) or placebo ( n=45 ) . Compared to the placebo group , the olanzapine group had a lower incidence of ( 59.2 % versus 91.1 % , p < 0.001 ) and a longer time to ( 46 versus 15 days , p < 0.001 ) symptomatic relapse of any kind . Olanzapine-treated patients also experienced longer time to depressive symptomatic relapse ( 85 versus 22 days , p=0.001 ) and manic symptomatic relapse ( too few relapses to calculate versus 42 days , p < 0.001 ) than did placebo-treated patients . CONCLUSIONS Compared with placebo , olanzapine treatment was associated with longer maintenance of response in patients presenting with a mixed index episode of bipolar I disorder .
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Intervention_Pharmacological
olanzapine
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Intervention_Control
placebo-controlled
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Intervention_Pharmacological
olanzapine
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Intervention_Control
placebo-controlled
38118
Intervention_Pharmacological
olanzapine
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Intervention_Pharmacological
olanzapine
38120
Intervention_Control
placebo
38121
Intervention_Pharmacological
olanzapine
38122
Intervention_Control
placebo
38123
Intervention_Pharmacological
olanzapine
38124
Intervention_Pharmacological
Olanzapine-treated
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Intervention_Control
placebo
38126
Intervention_Pharmacological
olanzapine
38127
Outcome_Physical
symptomatic relapse
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Outcome_Physical
symptomatic remission
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Outcome_Physical
symptomatic relapse
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Outcome_Physical
time to depressive symptomatic relapse
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Outcome_Physical
manic symptomatic relapse
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Outcome_Physical
maintenance of response
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Participant_Condition
bipolar 1 disorder
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Participant_Condition
mood episodes
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Participant_Sample-size
121
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Participant_Sample-size
304
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Participant_Condition
mixed index episode
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Participant_Condition
bipolar I disorder