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 .
Efficacy, long-term safety, and tolerability of ziprasidone in children and adolescents with bipolar disorder.
OBJECTIVE The purpose of this study was to evaluate the short- and long-term efficacy and safety of ziprasidone in children and adolescents with bipolar I disorder . METHODS Subjects 10 - 17 years of age with a manic or mixed episode associated with bipolar I disorder participated in a 4 week , r and omized , double-blind , placebo-controlled multicenter trial ( RCT ) followed by a 26 week open-label extension study ( OLE ) . Subjects were r and omized 2:1 to initially receive flexible-dose ziprasidone ( 40 - 160 mg/day , based on weight ) or placebo . Primary outcome was the change in Young Mania Rating Scale ( YMRS ) scores from baseline . Safety assessment s included weight and body mass index ( BMI ) , adverse events ( AEs ) , vital signs , laboratory measures , electrocardiograms , and movement disorder ratings . RESULTS In the RCT , 237 subjects were treated with ziprasidone ( n=149 ; mean age , 13.6 years ) or placebo ( n=88 ; mean age , 13.7 years ) . The estimated least squares mean changes in YMRS total ( intent-to-treat population ) were -13.83 ( ziprasidone ) and -8.61 ( placebo ; p=0.0005 ) at RCT endpoint . The most common AEs in the ziprasidone group were sedation ( 32.9 % ) , somnolence ( 24.8 % ) , headache ( 22.1 % ) , fatigue ( 15.4 % ) , and nausea ( 14.1 % ) . In the OLE , 162 subjects were enrolled , and the median duration of treatment was 98 days . The mean change in YMRS score from the end of the RCT to the end of the OLE ( last observation carried forward ) was -3.3 ( 95 % confidence interval , -5.0 to -1.6 ) . The most common AEs were sedation ( 26.5 % ) , somnolence ( 23.5 % ) , headache ( 22.2 % ) , and insomnia ( 13.6 % ) . For both the RCT and the OLE , no clinical ly significant mean changes in movement disorder scales , BMI z-scores , liver enzymes , or fasting lipids and glucose were observed . One subject on ziprasidone in the RCT and none during the OLE had Fridericia-corrected QT interval ( QTcF ) ≥ 460 ms . CONCLUSION These results demonstrate that ziprasidone is efficacious for treating children and adolescents with bipolar disorder .  Ziprasidone was generally well tolerated with a neutral metabolic profile . CLINICAL TRIALS REGISTRY NCT00257166 and NCT00265330 at Clinical Trials.gov
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 .