Steven G Potkin1, Miriam Cohen, John Panagides. 1. Department of Psychiatry and Human Behavior, University of California, Irvine, Brain Imaging Center, CA 92697-3960, USA. sgpotkin@uci.edu
Abstract
OBJECTIVE: This 6-week trial assessed the efficacy, tolerability, and safety of the investigational psychopharmacologic agent asenapine versus placebo and risperidone in patients with acute schizophrenia (DSM-IV criteria). METHOD:In a study conducted from August 2001 to May 2002, patients were randomly assigned to receive sublingual asenapine 5 mg b.i.d., placebo b.i.d., or oral risperidone 3 mg b.i.d. The primary outcome measure was improvement from baseline in Positive and Negative Syndrome Scale (PANSS) total score. Secondary outcomes included changes in Clinical Global Impressions-Severity of Illness (CGI-S) score and scores on PANSS positive, negative, and general psychopathology subscales. RESULTS: The intent-to-treat population comprised 174 patients who received >or= 1 dose of study drug and >or= 1 postbaseline assessment. At study end or last observation, mean improvements on PANSS total, negative subscale, and general psychopathology subscale scores were all significantly greater with asenapine than with placebo (p < .005, p = .01, and p < .005, respectively). Compared with placebo, improvements on CGI-S and PANSS positive subscale scores were significantly greater with both asenapine (p < .01 and p = .01) and risperidone (p < .005 and p < .05). Overall incidence rates of adverse events were comparable for asenapine and placebo, whereas risperidone was associated with substantial weight gain and prolactin elevation. CONCLUSION:Asenapine was effective and well tolerated in patients with acute schizophrenia and may provide a new option for control of negative symptoms.
RCT Entities:
OBJECTIVE: This 6-week trial assessed the efficacy, tolerability, and safety of the investigational psychopharmacologic agent asenapine versus placebo and risperidone in patients with acute schizophrenia (DSM-IV criteria). METHOD: In a study conducted from August 2001 to May 2002, patients were randomly assigned to receive sublingual asenapine 5 mg b.i.d., placebo b.i.d., or oral risperidone 3 mg b.i.d. The primary outcome measure was improvement from baseline in Positive and Negative Syndrome Scale (PANSS) total score. Secondary outcomes included changes in Clinical Global Impressions-Severity of Illness (CGI-S) score and scores on PANSS positive, negative, and general psychopathology subscales. RESULTS: The intent-to-treat population comprised 174 patients who received >or= 1 dose of study drug and >or= 1 postbaseline assessment. At study end or last observation, mean improvements on PANSS total, negative subscale, and general psychopathology subscale scores were all significantly greater with asenapine than with placebo (p < .005, p = .01, and p < .005, respectively). Compared with placebo, improvements on CGI-S and PANSS positive subscale scores were significantly greater with both asenapine (p < .01 and p = .01) and risperidone (p < .005 and p < .05). Overall incidence rates of adverse events were comparable for asenapine and placebo, whereas risperidone was associated with substantial weight gain and prolactin elevation. CONCLUSION:Asenapine was effective and well tolerated in patients with acute schizophrenia and may provide a new option for control of negative symptoms.
Authors: Marc De Hert; Weiping Yu; Johan Detraux; Kim Sweers; Ruud van Winkel; Christoph U Correll Journal: CNS Drugs Date: 2012-09-01 Impact factor: 5.749
Authors: Hugh M Marston; Jared W Young; Frederic D C Martin; Kevin A Serpa; Christopher L Moore; Erik H F Wong; Lisa Gold; Leonard T Meltzer; Marc R Azar; Mark A Geyer; Mohammed Shahid Journal: Psychopharmacology (Berl) Date: 2009-05-22 Impact factor: 4.530