Ignite Creation Date:
2024-05-05 @ 11:40 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00105326
Status:
COMPLETED
Last Update Posted:
2010-05-24
First Post:
2005-03-11
Brief Title:
Trial Evaluating Paliperidone Extended-Release ER Tablets Versus Placebo on Sleep in Schizophrenia Patients
Sponsor:
Johnson Johnson Pharmaceutical Research Development LLC
Organization:
Johnson Johnson Pharmaceutical Research Development LLC
Study Overview
Official Title:
A Double-blind Placebo-controlled Randomized Study Evaluating the Effect of Paliperidone ER Compared With Placebo on Sleep Architecture in Subjects With Schizophrenia
Status:
COMPLETED
Status Verified Date:
2010-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The primary objective of this study is to evaluate the amelioration of the sleep architecture of patients with schizophrenia and schizophrenia-related insomnia treated with either 9 mg of extended-release paliperidone ER or placebo using polysomnography
Detailed Description:
Paliperidone is the major active substance produced by the metabolism of risperidone in the body In patients with schizophrenia risperidone has been shown to improve the quality of sleep Therefore it is possible that treatment of paliperidone may improve sleep quality and potentially the quality of life in these patients The goal of this study is to test the hypothesis that paliperidone improves sleep architecture This trial is a multicenter double-blind neither the patient nor the physician will know if placebo or drug is being given and at what dose randomized patients will be assigned to different treatment groups based solely on chance placebo-controlled study in patients with schizophrenia and schizophrenia related insomnia The study consists of 2 phases a screening phase of up to 14 days and a double-blind phase of 15 days The primary purpose of this study is to evaluate improvement of the sleep architecture of patients with schizophrenia and schizophrenia-related insomnia treated with either 9 mgday of paliperidone ER or placebo for 14 days using polysomnography In this study polysomnography polygraphic recording during sleep of multiple body functions related to the state and stages of sleep to assess possible biological causes of sleep disorders will be used to measure sleep architecture and continuity Measurements will be taken on 2 days during the screening phase averaged for the baseline value and on the last 2 days of the treatment phase averaged for the end point value and will include measurement of non-rapid eye movement NREM sleep including the 4 stages of sleep and measures of rapid eye movement REM sleep Other assessments pertinent to the continuity and efficiency of sleep such as sleep latency the length of time that it takes to go from full wakefulness to Stage 2 sleep sleep efficiency proportion of sleep during time in bed sleep maintenance period of time between sleep onset and awakening and number of awakenings and sleep duration total sleep time will also be measured At baseline on Day 7 and at end of treatment the Positive and Negative Syndrome Scale PANSS will be used to assess the symptoms of schizophrenia and the Clinical Global Impression Scale - Severity CGI-S will be used to assess the severity of a patients condition Safety assessments include the incidence of adverse events throughout the study daily measurement of vital signs blood pressure pulse and temperature clinical laboratory tests performed both before the study initiation and at end of treatment and measurement of extrapyramidal symptoms using scales EPS scales at baseline Day 7 and end point 9 mg of paliperidone ER or placebo taken orally once daily on Days 1 to 14
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None