PMID- 20520283
OWN - NLM
STAT- MEDLINE
DCOM- 20110216
LR  - 20220330
IS  - 1533-712X (Electronic)
IS  - 0271-0749 (Linking)
VI  - 30
IP  - 2
DP  - 2010 Apr
TI  - Efficacy and safety of asenapine in a placebo- and haloperidol-controlled trial 
      in patients with acute exacerbation of schizophrenia.
PG  - 106-15
LID - 10.1097/JCP.0b013e3181d35d6b [doi]
AB  - Asenapine is approved by the Food and Drugs Administration in adults for acute 
      treatment of schizophrenia or of manic or mixed episodes associated with bipolar 
      I disorder with or without psychotic features. In a double-blind 6-week trial, 
      458 patients with acute schizophrenia were randomly assigned to fixed-dose 
      treatment with asenapine at 5 mg twice daily (BID), asenapine at 10 mg BID, 
      placebo, or haloperidol at 4 mg BID (to verify assay sensitivity). With last 
      observations carried forward (LOCF), mean Positive and Negative Syndrome Scale 
      total score reductions from baseline to endpoint were significantly greater with 
      asenapine at 5 mg BID (-16.2) and haloperidol (-15.4) than placebo (-10.7; both P 
      < 0.05); using mixed model for repeated measures (MMRM), changes at day 42 were 
      significantly greater with asenapine at 5 and 10 mg BID (-21.3 and -19.4, 
      respectively) and haloperidol (-20.0) than placebo (-14.6; all P < 0.05). On the 
      Positive and Negative Syndrome Scale positive subscale, all treatments were 
      superior to placebo with LOCF and MMRM; asenapine at 5 mg BID was superior to 
      placebo on the negative subscale with MMRM and on the general psychopathology 
      subscale with LOCF and MMRM. Treatment-related adverse events (AEs) occurred in 
      44% and 52%, 57%, and 41% of the asenapine at 5 and 10 mg BID, haloperidol, and 
      placebo groups, respectively. Extrapyramidal symptoms reported as AEs occurred in 
      15% and 18%, 34%, and 10% of the asenapine at 5 and 10 mg BID, haloperidol, and 
      placebo groups, respectively. Across all groups, no more than 5% of patients had 
      clinically significant weight change. Post hoc analyses indicated that efficacy 
      was similar with asenapine and haloperidol; greater contrasts were seen in AEs, 
      especially extrapyramidal symptoms.
FAU - Kane, John M
AU  - Kane JM
AD  - Department of Psychiatry, Zucker Hillside Hospital, Glen Oaks, NY 11004, USA. 
      psychiatry@lij.edu
FAU - Cohen, Michael
AU  - Cohen M
FAU - Zhao, Jun
AU  - Zhao J
FAU - Alphs, Larry
AU  - Alphs L
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  - United States
TA  - J Clin Psychopharmacol
JT  - Journal of clinical psychopharmacology
JID - 8109496
RN  - 0 (Dibenzocycloheptenes)
RN  - 0 (Heterocyclic Compounds, 4 or More Rings)
RN  - J6292F8L3D (Haloperidol)
RN  - JKZ19V908O (asenapine)
SB  - IM
MH  - Acute Disease
MH  - Adult
MH  - Akathisia, Drug-Induced/epidemiology
MH  - Dibenzocycloheptenes
MH  - Double-Blind Method
MH  - Female
MH  - Haloperidol/adverse effects/*therapeutic use
MH  - Heterocyclic Compounds, 4 or More Rings/adverse effects/*therapeutic use
MH  - Humans
MH  - Male
MH  - Parkinsonian Disorders/chemically induced/epidemiology
MH  - Schizophrenia/*drug therapy/epidemiology
MH  - Treatment Outcome
EDAT- 2010/06/04 06:00
MHDA- 2011/02/17 06:00
CRDT- 2010/06/04 06:00
PHST- 2010/06/04 06:00 [entrez]
PHST- 2010/06/04 06:00 [pubmed]
PHST- 2011/02/17 06:00 [medline]
AID - 00004714-201004000-00003 [pii]
AID - 10.1097/JCP.0b013e3181d35d6b [doi]
PST - ppublish
SO  - J Clin Psychopharmacol. 2010 Apr;30(2):106-15. doi: 10.1097/JCP.0b013e3181d35d6b.