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Daytime sleepiness associated with lurasidone and quetiapine XR: results from a randomized double-blind, placebo-controlled trial in patients with schizophrenia

  • Antony D. Loebel (a1), Cynthia O. Siu (a2), Josephine B. Cucchiaro (a1), Andrei A. Pikalov (a1) and Philip D. Harvey (a3)...

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.

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.

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Copyright

The online version of this article is published within an Open Access environment subject to the conditions of the Creative Commons Attribution-NonCommercial-ShareAlike licence . The written permission of Cambridge University Press must be obtained for commercial re-use.

Corresponding author

*Address for correspondence: Antony Loebel, MD, Sunovion Pharmaceuticals, Inc., One Bridge Plaza, Suite 510, Fort Lee, NJ 07024, USA. (Email: antony.loebel@sunovion.com)

Footnotes

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This work was supported by Sunovion Pharmaceuticals Inc.

Portions of this manuscript were previously presented at the New Clinical Drug Evaluation Unit (NCDEU) 52nd Annual Meeting, Phoenix, Arizona, May 29–June 1, 2012.

ClinicalTrials.gov Identifier: NCT00790192.

Footnotes

References

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