A double-blind, placebo-controlled, randomized study evaluating the effect of paliperidone extended-release tablets on sleep architecture in patients with schizophrenia

Abstract

The effects of paliperidone extended-release on sleep architecture in patients with schizophrenia-related insomnia were evaluated in this multicenter, double-blind, randomized, placebo-controlled study. Patients received paliperidone extended-release 9 mg/day or matching placebo during the 14-day double-blind phase. Sleep architecture and sleep continuity were evaluated using polysomnograms. Subjective sleep measures were evaluated daily using the Leeds Sleep Evaluation Questionnaire. Efficacy and safety were also assessed. Thirty-six patients (17 on paliperidone extended-release, 19 on placebo; mean age 32.2 years) completed the study. Paliperidone extended-release treatment vs. placebo resulted in clinically and statistically significant differences in sleep measurements from baseline to endpoint including a reduction in: persistent sleep latency (41 min), sleep onset latency (35 min), number of awakenings after sleep onset (7), time awake in bed (50 min), and stage 1 sleep duration (12 min); prolongation in: total sleep time (53 min), sleep period time (42 min), stage 2 sleep duration (51 min), and rapid eye movement sleep duration (18 min); and an increase in sleep efficiency index (11%). Paliperidone extended-release, compared with placebo, did not exacerbate daytime somnolence and improved symptoms of schizophrenia. Paliperidone extended-release was well tolerated and improved sleep architecture and sleep continuity in patients diagnosed with schizophrenia and concomitant insomnia.

A Randomized, Placebo-Controlled Study to Assess the Efficacy and Safety of 3 Doses of Paliperidone Palmitate in Adults With Acutely Exacerbated Schizophrenia

“…groups are consistent with data from studies of the oral formulation, paliperidone ER 5Y7 ; including a study that specifically investigated the effects of paliperidone ER on the sleep architecture and sleep continuity in patients with schizophrenia experiencing insomnia. 19 The incidence of discontinuations across treatment groups in this study (45%Y48% in the paliperidone palmitate groups, 57% in the placebo group) is consistent with rates reported in other drug studies in schizophrenia 20,21 and with rates observed in previous paliperidone palmitate studies. 9,10 One limitation of this study is that an active comparator was not included; hence, the relative efficacy of paliperidone palmitate compared with other active treatments is not known.…”

A Controlled, Evidence-Based Trial of Paliperidone Palmitate, A Long-Acting Injectable Antipsychotic, in Schizophrenia

“…These results are generally consistent with those from other recent studies of paliperidone palmitate for both the acute and maintenance treatment of patients with schizophrenia (Gopal et al, 2010;Hough et al, 2008Hough et al, , 2009Kramer et al, 2010), as well as for the oral formulation, paliperidone (Davidson et al, 2007;Kane et al, 2007;Kramer et al, 2007;Luthringer et al, 2007;Marder et al, 2007). Although in this study, paliperidone palmitate was administered gluteally, it may be administered in the deltoid muscle as well (Hough et al, 2009).…”

Paliperidone ER: a review of the clinical trial data

“…In this context, Luthringer et al (2007) conducted a randomized, double-blind, placebo-controlled, 3-week study in patients (n = 42) with schizophrenia-related insomnia to assess the effect of paliperidone ER (dosed Q AM) on sleep architecture. They also assessed the effect of this antipsychotic on patient-rated changes in sleep quality and daytime drowsiness based on the pooled data from the three pivotal trials.…”