Asenapine for long-term treatment of bipolar disorder: a double-blind 40-week
extension study.
Author(s): McIntyre RS, Cohen M, Zhao J, Alphs L, Macek TA, Panagides J.
Affiliation(s): Mood Disorders Psychopharmacology Unit, University Health Network, University of
Toronto, Toronto, ON, Canada. roger.mcintyre@uhn.on.ca
Publication date & source: 2010, J Affect Disord. , 126(3):358-65
BACKGROUND: Asenapine is approved in the United States for acute treatment of
manic or mixed episodes of bipolar I disorder with or without psychotic features.
We report the results of long-term treatment with asenapine in patients with
bipolar I disorder.
METHODS: Patients completing either of two 3-week efficacy trials and a
subsequent 9-week double-blind extension were eligible for this 40-week
double-blind extension. Patients in the 3-week trials were randomized to
flexible-dose asenapine (5 or 10mg BID), placebo, or olanzapine (5-20mg QD;
included for assay sensitivity only). Patients entering the extension phase
maintained their preestablished treatment; those originally randomized to placebo
received flexible-dose asenapine (placebo/asenapine). Safety and tolerability
endpoints included adverse events (AEs), extrapyramidal symptoms, laboratory
values, and anthropometric measures. Efficacy, a secondary assessment, was
measured as change in Young Mania Rating Scale (YMRS) total score from 3-week
trial baseline to week 52 with asenapine or olanzapine; the placebo/asenapine
group was assessed for safety only.
RESULTS: Incidence of treatment-emergent AEs was 71.9%, 86.1%, and 79.4% with
placebo/asenapine, asenapine, and olanzapine, respectively. The most frequent
treatment-emergent AEs were headache and somnolence with placebo/asenapine;
insomnia, sedation, and depression with asenapine; and weight gain, somnolence,
and sedation with olanzapine. Among observed cases, mean ± SD changes in YMRS
total score at week 52 were -28.6 ± 8.1 and -28.2 ± 6.8 for asenapine and
olanzapine, respectively.
LIMITATIONS: The study did not have a long-term placebo group.
CONCLUSIONS: In this 52-week extension in patients with bipolar mania, asenapine
was well tolerated and long-term maintenance of efficacy was supported.
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