Asenapine: Efficacy and safety of 5 and 10mg bid in a 3-week, randomized, double-blind, placebo-controlled trial in adults with a manic or mixed episode associated with bipolar I disorder.
BACKGROUND
Asenapine is an atypical antipsychotic for acute treatment of manic or mixed episodes associated with bipolar I disorder in adults. The recommended asenapine starting dose is 10mg bid with the option to reduce the dose to 5mg bid if needed due to adverse effects/tolerability.


METHODS
Phase IIIb, international, double-blind, fixed-dose, parallel-group, 3-week placebo-controlled trial of asenapine 5 and 10mg bid in adults with an acute bipolar I disorder manic or mixed episode. Primary outcome was difference in asenapine versus placebo in mean change from baseline to day 21 in the Young-Mania Rating Scale (YMRS) total score. Others included difference in asenapine versus placebo in the Clinical Global Impression Scale for Bipolar Severity (CGI-BP-S) and rate of YMRS responders.


RESULTS
Both asenapine doses were statistically superior to placebo in mean change from baseline to day 21 in YMRS total score (-10.9, -14.4, and -14.9 for placebo, asenapine 5mg bid, 10mg bid, respectively). Both asenapine doses had statistically superior improvement in mean change in CGI-BP-S score at day 21. Neither asenapine dose had significantly more YMRS responders at day 21 than placebo.


CONCLUSIONS
Results may not be generalizable to the entire population with bipolar I disorder owing to strict inclusion criteria.


CONCLUSIONS
This study evaluated, by a fixed-dose design, the efficacy and safety of asenapine versus placebo in patients with bipolar I disorder. Both asenapine 5 and 10mg bid were efficacious in treating mania associated with bipolar I disorder and were generally well tolerated.
Merck, Whitehouse Station, NJ, USA.
Ronald L
RL
Landbloom
Merck, Whitehouse Station, NJ, USA.
Mary
M
Mackle
Forest Research Institute (now Actavis), Jersey City, NJ, USA.
Xiao
X
Wu
Merck, Whitehouse Station, NJ, USA.
Linda
L
Kelly
Merck, Whitehouse Station, NJ, USA.
Linda
L
Snow-Adami
Mood Disorders Psychopharmacology Unit, University Health Network, University of Toronto, ON, Canada.
Roger S
RS
McIntyre
Forest Research Institute (now Actavis), Jersey City, NJ, USA.
Maju
M
Mathews
Forest Research Institute (now Actavis), Jersey City, NJ, USA. Electronic address: carlahundt@msn.com.
Carla
C
Hundt
D000293:Adolescent; D000328:Adult; D000368:Aged; D014150:Antipsychotic Agents / Q000627:therapeutic use; D001714:Bipolar Disorder / Q000188:drug therapy*; D003986:Dibenzocycloheptenes; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D006576:Heterocyclic Compounds, 4 or More Rings / Q000008:administration & dosage / Q000009:adverse effects* / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D008875:Middle Aged; D016896:Treatment Outcome; D055815:Young Adult
D014150:Antipsychotic Agents; D003986:Dibenzocycloheptenes; D006576:Heterocyclic Compounds, 4 or More Rings; C522667:asenapine
Asenapine; Bipolar disorder; Mania; Mixed