RESULTS There is sufficient evidence for a Grade A recommendation of the use of olanzapine plus fluoxetine at reducing depressive symptoms in bipolar depression and of quetiapine at high doses for depressive symptoms occurring during mixed episodes .
These results mostly overlap with the approved treatments for bipolar depression in adults
BACKGROUND The management of depressive and mixed symptoms in children and adolescents with bipolar disorder ( BD ) remains a matter of debate .
The goal of this review is , thus , to systematic ally examine the impact of atypical antipsychotics ( AAPs ) and mood stabilisers in the treatment of bipolar depression and /or mixed states .
Olanzapine/Fluoxetine combination in children and adolescents with bipolar I depression: a randomized, double-blind, placebo-controlled trial.
OBJECTIVE To assess the efficacy and safety of olanzapine/fluoxetine combination ( OFC ) for the acute treatment of bipolar depression in children and adolescents . METHOD Patients 10 to 17 years of age with bipolar I disorder ( BP-I ) , depressed episode , baseline Children 's Depression Rating Scale-Revised ( CDRS-R ) total score ≥40 , Young Mania Rating Scale ( YMRS ) total score ≤15 , and YMRS-item 1 ≤2 were r and omized to OFC ( 6/25 - 12/50 mg/day olanzapine/fluoxetine ; n = 170 ) or placebo ( n = 85 ) for up to 8 weeks of double-blind treatment . The primary efficacy measure was mean change in CDRS-R using mixed-model repeated- measures methodology . RESULTS Baseline-to-week-8 least-squares mean change in CDRS-R total score was greater for OFC-treated patients than for placebo-treated patients ( -28.4 versus -23.4 , p = .003 ; effect size = .46 ) , with between-group differences statistically significant at week 1 ( p = .02 ) and all subsequent visits ( all p < .01 ) . Rates of and times to response and remission were statistically significantly greater for OFC- than for placebo-treated patients . The most frequent treatment-emergent adverse events in the OFC group were weight gain , increased appetite , and somnolence . Mean weight gain at patient 's endpoint was significantly greater for OFC- than for placebo-treated patients ( 4.4 kg versus 0.5 kg , p < .001 ) . Treatment-emergent hyperlipidemia was very common among OFC-treated patients . Abnormal increases in hepatic analytes , prolactin , and corrected QT interval ( QTc ) were also common or very common but generally not clinical ly significant . CONCLUSION In this study , OFC was superior to placebo , and has been approved by the US Food and Drug Administration ( FDA ) for the acute treatment of bipolar I depression in patients 10 to 17 years of age . Benefits should be weighed against the risk of adverse events , particularly weight gain and hyperlipidemia . Clinical trial registration information-A Study for Assessing Treatment of Patients Ages 10 - 17 with Bipolar Depression ; http:// clinical trials.gov ; NCT00844857
RESULTS There is sufficient evidence for a Grade A recommendation of the use of olanzapine plus fluoxetine at reducing depressive symptoms in bipolar depression and of quetiapine at high doses for depressive symptoms occurring during mixed episodes .
These results mostly overlap with the approved treatments for bipolar depression in adults
BACKGROUND The management of depressive and mixed symptoms in children and adolescents with bipolar disorder ( BD ) remains a matter of debate .
The goal of this review is , thus , to systematic ally examine the impact of atypical antipsychotics ( AAPs ) and mood stabilisers in the treatment of bipolar depression and /or mixed states .