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 Objectives 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 (...

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Bibliographic Details
Published in:Schizophrenia research 2015-03, Vol.162 (1), p.162-168
Main Authors: Riedel, Michael, Schmitz, Margot, Østergaard, Peter Kåre, Ferrannini, Luigi, Franco, Manuel A, Alfano, Vincenza, Vansvik, Eva Dencker
Format: Article
Language:English
Subjects:
Adult
Antipsychotic Agents - administration & dosage
Antipsychotic Agents - adverse effects
Antipsychotic Agents - blood
Attention - drug effects
Cognition - drug effects
Cross-Over Studies
Daytime cognitive function
Delayed-Action Preparations
Double-Blind Method
Europe
Female
Humans
Male
Neuropsychological Tests
Patient Satisfaction
Photoperiod
Prospective Studies
Psychiatry
Quetiapine extended release
Quetiapine Fumarate - administration & dosage
Quetiapine Fumarate - adverse effects
Quetiapine Fumarate - blood
Quetiapine immediate release
Schizophrenia - drug therapy
Schizophrenic Psychology
Stable schizophrenia
Treatment Outcome
Treatment satisfaction
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Summary:Abstract Objectives 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 (400–750 mg). After 10–16 days on formulation 1, patients switched to formulation 2. Assessments from three post-dose visits (≥ 5 days 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 37.8 years). 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. Conclusion Daytime cognitive performance was similar for both groups. XR was associated with less daytime sedation and improved patient satisfaction than IR.
ISSN:0920-9964
1573-2509
DOI:10.1016/j.schres.2014.12.027