BERLIN – Daytime sleepiness was reduced when patients with schizophrenia were placed on lurasidone but increased when assigned to quetiapine extended-release, in a randomized trial.
This improvement in daytime sleepiness in patients treated with lurasidone had important clinical consequences: namely, significantly better scores on measures of cognition and functional capacity, Dr. Antony Loebel reported at the annual congress of the European College of Neuropsychopharmacology.
He presented a post hoc analysis of a 6-week, double-blind, placebo-controlled randomized trial. The study population comprised 486 patients with an acute exacerbation of schizophrenia who were randomized to fixed-dose therapy with lurasidone (Latuda) 80 mg, lurasidone 160 mg, quetiapine extended release (Seroquel XR) 600 mg, or placebo, all dosed once daily with food in the evening.
Daytime sleepiness as assessed by the Epworth Sleepiness Scale (ESS) improved significantly from baseline in the two lurasidone groups and in placebo-treated controls while worsening significantly in the quetiapine group. The mean total ESS score decreased by 0.7 points in the lower-dose lurasidone group, 1.1 points in patients on lurasidone at 160 mg/day, and 0.9 points in controls. In contrast, the mean score rose by 0.6 points in the quetiapine group.
Daytime sleepiness was associated with reduced agitation as assessed by the PANSS (Positive and Negative Syndrome Scale) excitement subscale. However, this came at the cost of reduced functional capacity.
Specifically, the quetiapine group showed significantly increased sleepiness in five of the eight daytime scenarios assessed in the ESS: dozing when talking, sitting and reading, watching television, sitting quietly after lunch without alcohol, and during afternoon resting.
Moreover, as daytime sleepiness increased, functional capacity evaluated via the UCSD Performance-Based Skills Assessment, Brief, worsened, as did cognitive performance as assessed by the CogState Computerized Schizophrenia Battery, according to Dr. Loebel, executive vice president and chief medical officer at Sunovion Pharmaceuticals in Fort Lee, N.J.
Lurasidone at 160 mg/day not only yielded the greatest improvement from baseline in daytime sleepiness, it also demonstrated a significant improvement in overall cognitive performance when compared to quetiapine and placebo.
The psychiatrist concluded that the impact of daytime sleepiness on key treatment outcomes is underappreciated. Daytime sleepiness is generally not assessed with a validated scale. The ESS is a quick, practical, well-validated tool for this purpose that’s well suited for use in clinical practice, he added.