title: Daytime sleepiness associated with lurasidone and quetiapine XR: results from a randomized double-blind, placebo-controlled trial in patients with schizophrenia.
abstract: 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.
  
  
  CONCLUSIONS
  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: 1 Sunovion Pharmaceuticals Inc., Marlborough, Massachusetts, USA.
authors: Antony D
authors: AD
authors: Loebel
authors: 2 Data Power (DP) Inc., Flemington, New Jersey, USA.
authors: Cynthia O
authors: CO
authors: Siu
authors: 1 Sunovion Pharmaceuticals Inc., Marlborough, Massachusetts, USA.
authors: Josephine B
authors: JB
authors: Cucchiaro
authors: 1 Sunovion Pharmaceuticals Inc., Marlborough, Massachusetts, USA.
authors: Andrei A
authors: AA
authors: Pikalov
authors: 3 University of Miami Miller School of Medicine, Miami, Florida, USA.
authors: Philip D
authors: PD
authors: Harvey
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D014150:Antipsychotic Agents / Q000627:therapeutic use*; D003072:Cognition Disorders / Q000139:chemically induced; D003987:Dibenzothiazepines / Q000627:therapeutic use*; D006970:Disorders of Excessive Somnolence / Q000188:drug therapy* / Q000209:etiology*; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D054833:Isoindoles / Q000627:therapeutic use*; D000069056:Lurasidone Hydrochloride; D008297:Male; D008875:Middle Aged; D011569:Psychiatric Status Rating Scales; D000069348:Quetiapine Fumarate; D012559:Schizophrenia / Q000150:complications*; D013844:Thiazoles / Q000627:therapeutic use*; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D014150:Antipsychotic Agents; D003987:Dibenzothiazepines; D054833:Isoindoles; D013844:Thiazoles; D000069348:Quetiapine Fumarate; D000069056:Lurasidone Hydrochloride