title: Comparison of the effects of quetiapine extended-release and quetiapine immediate-release on cognitive performance, sedation and patient satisfaction in patients with schizophrenia: a randomised, double-blind, crossover study (eXtRa).
abstract: OBJECTIVE
  To assess daytime cognitive performance, sedation and treatment satisfaction in patients with schizophrenia receiving quetiapine extended release (XR) versus quetiapine immediate release (IR).
  
  
  METHODS
  Phase IV prospective, double-blind, crossover study (NCT01213836). Patients (N=66) with stable schizophrenia, treated with XR or IR before study start, were randomised (1:1) to treatment with XR followed by IR, or IR followed by XR, at the dose received before enrolment (400-750mg). After 10-16days on formulation 1, patients switched to formulation 2. Assessments from three post-dose visits (≥5days following treatment on each formulation) were analysed. Cognitive performance was measured by CogState Cognition testing. Sedation, treatment satisfaction and safety were also assessed.
  
  
  RESULTS
  65 patients received treatment (69.2% male; mean age 37.8years). Daytime cognitive functioning was similar for both groups; adjusted mean difference in Attentional Composite Score in XR and IR patients was 0.005 (p=0.907). Patients receiving XR were less sedated than those receiving IR, (Bond-Lader visual analogue scale score, mean [SD]: 23.5 [19.0] vs 28.6 [21.4]); estimated overall treatment difference: 5.2 (95% CI: 2.3, 8.2; p<0.0009). Patients receiving XR reported feeling less sedated than those on IR (Stanford Sleepiness Scale, mean [SD]: 2.4 [0.9] vs 2.6 [1.0]); estimated overall treatment difference: 0.28 (95% CI: 0.12, 0.43; p<0.0008). Patients reported improved overall treatment satisfaction (p=0.0417) and milder side effects (p=0.0035) with XR. Safety profile was similar in both groups.
  
  
  CONCLUSIONS
  Daytime cognitive performance was similar for both groups. XR was associated with less daytime sedation and improved patient satisfaction than IR.
authors.affiliation: Vinzenz von Paul Hospital, Rottweil, Germany. Electronic address: m.riedel@vvph.de.
authors.forename: Michael
authors.initials: M
authors.lastname: Riedel
authors.affiliation: Institute for Psychosomatic Medicine, Vienna, Austria.
authors.forename: Margot
authors.initials: M
authors.lastname: Schmitz
authors.affiliation: Private Practice, Middelfart, Denmark.
authors.forename: Peter Kåre
authors.initials: PK
authors.lastname: Østergaard
authors.affiliation: Department of Mental Health and Addictions ASL3, Genoa, Italy.
authors.forename: Luigi
authors.initials: L
authors.lastname: Ferrannini
authors.affiliation: Psychiatric Department, Zamora Hospital, Zamora, Spain; Salamanca University, Spain.
authors.forename: Manuel A
authors.initials: MA
authors.lastname: Franco
authors.affiliation: Department of Mental Health ASLNA3sud, Torre Annunziata, NA, Italy.
authors.forename: Vincenza
authors.initials: V
authors.lastname: Alfano
authors.affiliation: AstraZeneca Nordics, Södertälje, Sweden.
authors.forename: Eva Dencker
authors.initials: ED
authors.lastname: Vansvik
mesh_terms: D000328:Adult; D014150:Antipsychotic Agents / Q000008:administration & dosage* / Q000009:adverse effects / Q000097:blood; D001288:Attention / Q000187:drug effects; D003071:Cognition / Q000187:drug effects; D018592:Cross-Over Studies; D003692:Delayed-Action Preparations; D004311:Double-Blind Method; D005060:Europe; D005260:Female; D006801:Humans; D008297:Male; D009483:Neuropsychological Tests; D017060:Patient Satisfaction; D017440:Photoperiod; D011446:Prospective Studies; D000069348:Quetiapine Fumarate / Q000008:administration & dosage* / Q000009:adverse effects / Q000097:blood; D012559:Schizophrenia / Q000188:drug therapy*; D012565:Schizophrenic Psychology; D016896:Treatment Outcome
chemical_list: D014150:Antipsychotic Agents; D003692:Delayed-Action Preparations; D000069348:Quetiapine Fumarate
keywords: Daytime cognitive function; Quetiapine extended release; Quetiapine immediate release; Stable schizophrenia; Treatment satisfaction