PMID- 21367356
OWN - NLM
STAT- MEDLINE
DCOM- 20110531
LR  - 20220410
IS  - 1555-2101 (Electronic)
IS  - 0160-6689 (Linking)
VI  - 72
IP  - 3
DP  - 2011 Mar
TI  - A randomized placebo-controlled trial of asenapine for the prevention of relapse 
      of schizophrenia after long-term treatment.
PG  - 349-55
LID - 10.4088/JCP.10m06306 [doi]
AB  - OBJECTIVE: Long-term efficacy of asenapine in preventing schizophrenia relapse 
      was assessed in a 26-week double-blind, placebo-controlled trial that followed 26 
      weeks of open-label treatment. METHOD: Stable schizophrenia patients (DSM-IV-TR 
      criteria) who were cross-titrated from previous medication to sublingual 
      asenapine and remained stable during 26 weeks of open-label treatment were 
      eligible for 26 weeks of double-blind treatment, with randomization to continued 
      asenapine or switch to placebo. Time to relapse/impending relapse (primary 
      endpoint, as usually determined by specific scores on the Positive and Negative 
      Syndrome Scale and the Clinical Global Impressions-Severity of Illness Scale) and 
      discontinuation for any reason (key secondary endpoint) were assessed by survival 
      analyses for asenapine versus placebo. The study was conducted from May 2005 
      through June 2008. RESULTS: Of 700 enrolled patients treated with open-label 
      asenapine, 386 entered (asenapine, n = 194; placebo, n = 192) and 207 completed 
      (n = 135; n = 72) the double-blind phase. Times to relapse/impending relapse and 
      discontinuation for any reason were significantly longer with asenapine than with 
      placebo (both P < .0001). Incidence of relapse/impending relapse was lower with 
      asenapine than placebo (12.1% vs 47.4%, P < .0001). The modal dosage of asenapine 
      was 10 mg twice daily in both phases. During the double-blind phase, the 
      incidence of adverse events (AEs) considered serious with asenapine and placebo 
      was 3.1% and 9.9%, respectively; incidence of extrapyramidal symptom-related AEs 
      was 3.1% and 4.7%, respectively. The most frequently reported AEs with asenapine 
      versus placebo were anxiety (8.2%; 10.9%), increased weight (6.7%; 3.6%), and 
      insomnia (6.2%; 13.5%). The incidence of clinically significant weight gain (>/= 7% 
      increase from double-blind baseline) was 3.7% with asenapine and 0.5% with 
      placebo. CONCLUSIONS: Long-term treatment with asenapine was more effective than 
      placebo in preventing relapse of schizophrenia and appeared to be safe and well 
      tolerated. TRIAL REGISTRATION: clinicaltrials.gov Identifier NCT00150176.
CI  - (c) Copyright 2011 Physicians Postgraduate Press, Inc.
FAU - Kane, John M
AU  - Kane JM
AD  - Department of Psychiatry, Zucker Hillside Hospital, 75-59 263rd St, Kaufmann 
      Bldg, Ste 103, Glen Oaks, NY 11004, USA. psychiatry@lij.edu
FAU - Mackle, Mary
AU  - Mackle M
FAU - Snow-Adami, Linda
AU  - Snow-Adami L
FAU - Zhao, Jun
AU  - Zhao J
FAU - Szegedi, Armin
AU  - Szegedi A
FAU - Panagides, John
AU  - Panagides J
LA  - eng
SI  - ClinicalTrials.gov/NCT00150176
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20110222
PL  - United States
TA  - J Clin Psychiatry
JT  - The Journal of clinical psychiatry
JID - 7801243
RN  - 0 (Antipsychotic Agents)
RN  - 0 (Dibenzocycloheptenes)
RN  - 0 (Heterocyclic Compounds, 4 or More Rings)
RN  - JKZ19V908O (asenapine)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Aged
MH  - Antipsychotic Agents/adverse effects/*therapeutic use
MH  - Anxiety/chemically induced
MH  - Dibenzocycloheptenes
MH  - Double-Blind Method
MH  - Female
MH  - Heterocyclic Compounds, 4 or More Rings/adverse effects/*therapeutic use
MH  - Humans
MH  - Kaplan-Meier Estimate
MH  - Male
MH  - Middle Aged
MH  - Psychiatric Status Rating Scales
MH  - Schizophrenia/drug therapy/*prevention & control
MH  - Secondary Prevention
MH  - Sleep Initiation and Maintenance Disorders/chemically induced
MH  - Treatment Outcome
MH  - Weight Gain/drug effects
MH  - Young Adult
EDAT- 2011/03/04 06:00
MHDA- 2011/06/01 06:00
CRDT- 2011/03/04 06:00
PHST- 2010/06/03 00:00 [received]
PHST- 2010/12/09 00:00 [accepted]
PHST- 2011/03/04 06:00 [entrez]
PHST- 2011/03/04 06:00 [pubmed]
PHST- 2011/06/01 06:00 [medline]
AID - 10.4088/JCP.10m06306 [doi]
PST - ppublish
SO  - J Clin Psychiatry. 2011 Mar;72(3):349-55. doi: 10.4088/JCP.10m06306. Epub 2011 
      Feb 22.