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.
|
Authors | Remy Luthringer, Luc Staner, Nadine Noel, Muriel Muzet, Cristiana Gassmann-Mayer, Krishna Talluri, Adriaan Cleton, Marielle Eerdekens, Wendy P Battisti, Joseph M Palumbo |
Journal | International clinical psychopharmacology
(Int Clin Psychopharmacol)
Vol. 22
Issue 5
Pg. 299-308
(Sep 2007)
ISSN: 0268-1315 [Print] England |
PMID | 17690599
(Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
|
Chemical References |
- Antipsychotic Agents
- Delayed-Action Preparations
- Isoxazoles
- Pyrimidines
- Tablets
- Paliperidone Palmitate
|
Topics |
- Adult
- Antipsychotic Agents
(administration & dosage, adverse effects)
- Delayed-Action Preparations
- Double-Blind Method
- Dyskinesia, Drug-Induced
(diagnosis)
- Female
- Hospitalization
- Humans
- Isoxazoles
(administration & dosage, adverse effects)
- Male
- Middle Aged
- Paliperidone Palmitate
- Polysomnography
(drug effects)
- Psychiatric Status Rating Scales
- Pyrimidines
(administration & dosage, adverse effects)
- Schizophrenia
(diagnosis, drug therapy)
- Schizophrenic Psychology
- Sleep Stages
(drug effects)
- Tablets
|