HOMEPRODUCTSCOMPANYCONTACTFAQResearchDictionaryPharmaSign Up FREE or Login

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.
AuthorsRemy Luthringer, Luc Staner, Nadine Noel, Muriel Muzet, Cristiana Gassmann-Mayer, Krishna Talluri, Adriaan Cleton, Marielle Eerdekens, Wendy P Battisti, Joseph M Palumbo
JournalInternational clinical psychopharmacology (Int Clin Psychopharmacol) Vol. 22 Issue 5 Pg. 299-308 (Sep 2007) ISSN: 0268-1315 [Print] England
PMID17690599 (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

Join CureHunter, for free Research Interface BASIC access!

Take advantage of free CureHunter research engine access to explore the best drug and treatment options for any disease. Find out why thousands of doctors, pharma researchers and patient activists around the world use CureHunter every day.
Realize the full power of the drug-disease research graph!


Choose Username:
Email:
Password:
Verify Password:
Enter Code Shown: