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

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

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

Remy Luthringer,Luc Staner,Nadine Noel,Muriel Muzet,Cristiana Gassmann-Mayer,Krishna Talluri,Adriaan Cleton,Marielle Eerdekens,Wendy P Battisti,Joseph M Palumbo,

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 double-blind, placebo-controlled, randomized study evaluating the effect of paliperidone extended-release tablets on sleep architecture in patients with schizophrenia. Publishing Authors By Initials

R Luthringer,L Staner,N Noel,M Muzet,C Gassmann-Mayer,K Talluri,A Cleton,M Eerdekens,WP Battisti,JM Palumbo,

For similar pharmaceutical preparations: dosage forms: tablets research abstracts see: pharmaceutical preparations: dosage forms: tablets research

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

PUBLICATION TYPE: Research Support, Non-U.S. Gov

Journal: International clinical psychopharmacology

VOLUME: 22

Page Numbers: 299-308

Journal Abbreviation:

ISSN: 0268-1315

DAY: 20

MONTH: Sep

YEAR: 2007

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

Number of References:

LANGUAGE: eng

NlmUniqueID: 8609061

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

KEYWORDS: Tablets

MESH TERMS: drug effects

Chemical & Substance for Abstract: A double-blind, placebo-controlled, randomized study evaluating the effect of paliperidone extended-release tablets on sleep architecture in patients with schizophrenia. Information

Substance Name: 9-hydroxy-risperidone

Registry Number: 144598-75-4

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

AFFILIATION: Executive Department, Forenap Pharma, 27 rue du 4éme RSM, Rouffach 68250, France. remy.luthringer@forenap.com

Country: England

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MEDLINETA: Int Clin Psychopharmacol

REFSOURCE: Int Clin Psychopharmacol. 2007 Nov;22(6)

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