OBJECTIVE: The aim of this analysis was to compare the effects of 2 atypical antipsychotic agents, lurasidone (80 mg/d or 160 mg/d) and quetiapine XR (600 mg/d), on daytime alertness, and to evaluate the effects of daytime sleepiness on treatment outcomes in patients with an acute exacerbation of schizophrenia. METHODS:Patients who met Diagnostic and Statistical Manual of Mental Disorders, 4th edition, text revision (DSM-IV-TR) criteria for schizophrenia were randomized to 6 weeks of double-blind treatment with fixed doses of lurasidone 80 mg/d (n = 125), lurasidone 160 mg/d (n = 121), quetiapine XR 600 mg/d (n = 119), or placebo (n = 121), all dosed once daily in the evening, with food. Daytime sleepiness was assessed using the Epworth Sleepiness Scale (ESS). RESULTS:Daytime sleepiness improved in the lurasidone and placebo-treated groups but worsened in the quetiapine XR treatment group when compared to placebo (p = 0.001) and to either dose of lurasidone (both p < 0.01). Sedation associated with quetiapine XR treatment mediated an improvement in agitation [assessed by the Positive and Negative Syndrome Scale-Excitement (PANSS-EC) subscale] and a worsening in functional capacity [assessed by the University of California-San Diego (UCSD) Performance-Based Skills Assessment-Brief Version (UPSA-B) total score]; these mediating relationships were not observed for the lurasidone or placebo treatment groups. CONCLUSION: In this 6-week double-blind study, treatment with lurasidone 80 mg or 160 mg, administered once daily in the evening, was associated with a reduction in daytime sleepiness similar in magnitude to placebo, while quetiapine XR 600 mg/d was associated with a significant increase in daytime sleepiness, compared to both lurasidone dose groups and placebo. Daytime sleepiness was associated with improvement in agitation and worsening in functional capacity for quetiapine XR, but not lurasidone or placebo-treated patients.
RCT Entities:
OBJECTIVE: The aim of this analysis was to compare the effects of 2 atypical antipsychotic agents, lurasidone (80 mg/d or 160 mg/d) and quetiapine XR (600 mg/d), on daytime alertness, and to evaluate the effects of daytime sleepiness on treatment outcomes in patients with an acute exacerbation of schizophrenia. METHODS:Patients who met Diagnostic and Statistical Manual of Mental Disorders, 4th edition, text revision (DSM-IV-TR) criteria for schizophrenia were randomized to 6 weeks of double-blind treatment with fixed doses of lurasidone 80 mg/d (n = 125), lurasidone 160 mg/d (n = 121), quetiapine XR 600 mg/d (n = 119), or placebo (n = 121), all dosed once daily in the evening, with food. Daytime sleepiness was assessed using the Epworth Sleepiness Scale (ESS). RESULTS:Daytime sleepiness improved in the lurasidone and placebo-treated groups but worsened in the quetiapine XR treatment group when compared to placebo (p = 0.001) and to either dose of lurasidone (both p < 0.01). Sedation associated with quetiapine XR treatment mediated an improvement in agitation [assessed by the Positive and Negative Syndrome Scale-Excitement (PANSS-EC) subscale] and a worsening in functional capacity [assessed by the University of California-San Diego (UCSD) Performance-Based Skills Assessment-Brief Version (UPSA-B) total score]; these mediating relationships were not observed for the lurasidone or placebo treatment groups. CONCLUSION: In this 6-week double-blind study, treatment with lurasidone 80 mg or 160 mg, administered once daily in the evening, was associated with a reduction in daytime sleepiness similar in magnitude to placebo, while quetiapine XR 600 mg/d was associated with a significant increase in daytime sleepiness, compared to both lurasidone dose groups and placebo. Daytime sleepiness was associated with improvement in agitation and worsening in functional capacity for quetiapine XR, but not lurasidone or placebo-treated patients.
Authors: W Wolfgang Fleischhacker; Martti E Heikkinen; Jean-Pierre Olié; Wally Landsberg; Patricia Dewaele; Robert D McQuade; Jean-Yves Loze; Delphine Hennicken; Wendy Kerselaers Journal: Int J Neuropsychopharmacol Date: 2010-05-12 Impact factor: 5.176
Authors: Philip D Harvey; Cynthia O Siu; Jay Hsu; Josephine Cucchiaro; Paul Maruff; Antony Loebel Journal: Eur Neuropsychopharmacol Date: 2013-08-27 Impact factor: 4.600
Authors: Antony Loebel; Josephine Cucchiaro; Kaushik Sarma; Lei Xu; Chuanchieh Hsu; Amir H Kalali; Andrei Pikalov; Steven G Potkin Journal: Schizophr Res Date: 2013-02-13 Impact factor: 4.939
Authors: D V Sheehan; Y Lecrubier; K H Sheehan; P Amorim; J Janavs; E Weiller; T Hergueta; R Baker; G C Dunbar Journal: J Clin Psychiatry Date: 1998 Impact factor: 4.384
Authors: Philip D Harvey; Howard Hassman; Lian Mao; Georges M Gharabawi; Ramy A Mahmoud; Luella M Engelhart Journal: J Clin Psychiatry Date: 2007-08 Impact factor: 4.384
Authors: James B Lohr; Lianqi Liu; Michael P Caligiuri; Taylor P Kash; Todd A May; Jody Delapena Murphy; Sonia Ancoli-Israel Journal: Schizophr Res Date: 2013-08-09 Impact factor: 4.939
Authors: Philip D Harvey; Marta Bosia; Roberto Cavallaro; Oliver D Howes; René S Kahn; Stefan Leucht; Daniel R Müller; Rafael Penadés; Antonio Vita Journal: Schizophr Res Cogn Date: 2022-03-22