Asenapine: Efficacy and safety of 5 and 10 mg bid in a 3-week, randomized, double-blind, placebo-controlled trial in adults with a manic or mixed episode associated with bipolar I disorder

2016 ◽  
Vol 190 ◽  
pp. 103-110 ◽  
Author(s):  
Ronald L. Landbloom ◽  
Mary Mackle ◽  
Xiao Wu ◽  
Linda Kelly ◽  
Linda Snow-Adami ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Efficacy And Safety ◽  
Double Blind ◽  
Mixed Episode ◽  
Bipolar I Disorder ◽  
Double Blind Placebo

A Double-Blind, Placebo-controlled Trial of Divalproex and Olanzapine in Bipolar I Disorder, Mixed Episode

2009 ◽  
Vol 24 (S1) ◽  
pp. 1-1
Author(s):  
J. Houston ◽  
M. Tohen ◽  
E. Degenhardt ◽  
H. Jamal ◽  
L. Liu ◽  
...  
Keyword(s):  
Rating Scale ◽  
Controlled Trial ◽  
Blood Levels ◽  
Young Mania ◽  
Double Blind ◽  
Mixed Episode ◽  
Bipolar I Disorder ◽  
Double Blind Placebo ◽  
Concomitant Medications ◽  
Unique Study

Aims:This unique study of treatment of the mixed state of bipolar I disorder using simultaneous depression and mania response criteria compared divalproex monotherapy versus olanzapine augmentation in a 6-week, randomized, double-blind trial.Methods:Patients (age 18-60 years) with 14-28 days of divalproex monotherapy (blood levels of 75-125 μg/mL) were randomized to augmentation with olanzapine 5-20 mg/day or placebo. Data collected included: Hamilton Depression Rating Scale (HDRS), Young Mania Rating Scale (YMRS), Clinical Global Impression for Bipolar Illness (CGI-BP), hospitalizations, concomitant medications, and adverse events (AEs). Primary co-objectives were comparisons of baseline to endpoint changes in HDRS and YMRS. Secondary objectives included comparisons of times to onset (25% reduction) and response (50% reduction) in both HDRS and YMRS, change in CGI-BP, hospitalizations, and safety.Results:Patients were 59% female, 51% Caucasian, 33% African American, and 14% Hispanic with mean standard deviation (SD) HDRS and YMRS scores of 22.2 (4.5) and 20.9 (4.4). Mean standard error (SE) score changes for the olanzapine (n=100) or placebo (n=101) arms, respectively, were: HDRS, -9.37 (.55) and -7.69 (.54), p=.022; YMRS, -10.15 (.44) and -7.68 (.44), p< .001; and CGI-BP, -1.34 (.11) and -1.06 (.11), p=.056. Times-to-onset (median 7 vs 14 days) and response (median 25 vs 49 days) were significantly shorter for olanzapine augmentation. One olanzapine patient required hospitalization (p=1.0). Treatment-emergent AEs were consistent with previously-published rates.Conclusion:Six-week olanzapine treatment augmentation was associated with greater and earlier reduction of manic and depressive symptoms in mixed episode patients on divalproex treatment.

scholarly journals Efficacy and safety of vernakalant in patients with atrial flutter: a randomized, double-blind, placebo-controlled trial

EP Europace ◽  
2012 ◽  
Vol 14 (6) ◽  
pp. 804-809 ◽  
Author(s):  
A. J. Camm ◽  
E. Toft ◽  
C. Torp-Pedersen ◽  
P. Vijayaraman ◽  
S. Juul-Moller ◽  
...  
Keyword(s):  
Atrial Flutter ◽  
Controlled Trial ◽  
Efficacy And Safety ◽  
Double Blind ◽  
Double Blind Placebo
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