PMID- 20537396
OWN - NLM
STAT- MEDLINE
DCOM- 20110126
LR  - 20220330
IS  - 1573-2517 (Electronic)
IS  - 0165-0327 (Linking)
VI  - 126
IP  - 3
DP  - 2010 Nov
TI  - Asenapine for long-term treatment of bipolar disorder: a double-blind 40-week 
      extension study.
PG  - 358-65
LID - 10.1016/j.jad.2010.04.005 [doi]
AB  - 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.
CI  - Copyright (c) 2010 Elsevier B.V. All rights reserved.
FAU - McIntyre, Roger S
AU  - McIntyre RS
AD  - Mood Disorders Psychopharmacology Unit, University Health Network, University of 
      Toronto, Toronto, ON, Canada. roger.mcintyre@uhn.on.ca
FAU - Cohen, Miriam
AU  - Cohen M
FAU - Zhao, Jun
AU  - Zhao J
FAU - Alphs, Larry
AU  - Alphs L
FAU - Macek, Thomas A
AU  - Macek TA
FAU - Panagides, John
AU  - Panagides J
LA  - eng
PT  - Comparative Study
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - Netherlands
TA  - J Affect Disord
JT  - Journal of affective disorders
JID - 7906073
RN  - 0 (Antipsychotic Agents)
RN  - 0 (Dibenzocycloheptenes)
RN  - 0 (Heterocyclic Compounds, 4 or More Rings)
RN  - 12794-10-4 (Benzodiazepines)
RN  - JKZ19V908O (asenapine)
RN  - N7U69T4SZR (Olanzapine)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Aged
MH  - Antipsychotic Agents/adverse effects/*therapeutic use
MH  - Benzodiazepines/adverse effects/therapeutic use
MH  - Bipolar Disorder/*drug therapy
MH  - Dibenzocycloheptenes
MH  - Double-Blind Method
MH  - Female
MH  - Heterocyclic Compounds, 4 or More Rings/adverse effects/*therapeutic use
MH  - Humans
MH  - Long-Term Care
MH  - Male
MH  - Middle Aged
MH  - Olanzapine
MH  - Psychiatric Status Rating Scales/statistics & numerical data
MH  - Psychometrics
MH  - Young Adult
EDAT- 2010/06/12 06:00
MHDA- 2011/01/28 06:00
CRDT- 2010/06/12 06:00
PHST- 2009/12/15 00:00 [received]
PHST- 2010/03/18 00:00 [revised]
PHST- 2010/04/09 00:00 [accepted]
PHST- 2010/06/12 06:00 [entrez]
PHST- 2010/06/12 06:00 [pubmed]
PHST- 2011/01/28 06:00 [medline]
AID - S0165-0327(10)00341-1 [pii]
AID - 10.1016/j.jad.2010.04.005 [doi]
PST - ppublish
SO  - J Affect Disord. 2010 Nov;126(3):358-65. doi: 10.1016/j.jad.2010.04.005.