Trial Evaluating Paliperidone Extended-Release (ER) Tablets Versus Placebo on Sleep in Schizophrenia Patients

May 20, 2010 updated by: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

A Double-blind, Placebo-controlled, Randomized Study Evaluating the Effect of Paliperidone ER Compared With Placebo on Sleep Architecture in Subjects With Schizophrenia

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 mg/day 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 Type

Interventional

Enrollment (Actual)

5

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diagnosed with schizophrenia and schizophrenia-related insomnia, no relapse or psychosis for at least 3 months before screening, and considered symptomatically stable
  • have apnea/hypopnea score <10 and periodic leg movement score with an arousal index <10
  • Weigh >/= 50 kg (>/=110 lbs), with a BMI >/= 18 and </= 35 kg/m2, inclusive
  • Agree to adhere to sleep schedule
  • Have a sleep history of a minimum of 1.5 hours of wakefulness out of 8 hours in bed.

Exclusion Criteria:

  • Current history of suicidal or violent behavior or have exhibited this behavior within the past 6 months
  • diagnosis of primary insomnia
  • unstable blood pressure
  • sleep problems related to general medical conditions, or substance abuse
  • diagnosis of or evidence of narcolepsy
  • preexisting severe gastrointestinal narrowing.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
The change from baseline at endpoint in sleep architecture and continuity measurements including sleep time, latency to sleep onset and to persistent sleep, sleep efficiency, time awake & awakenings after sleep onset, Stage 3&4 sleep duration, REM sleep

Secondary Outcome Measures

Outcome Measure
Changes in the PANSS scores from baseline to end of treatment and the CGI-S score at each time point. Incidence of adverse events throughout study.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2005

Study Completion (Actual)

August 1, 2005

Study Registration Dates

First Submitted

March 11, 2005

First Submitted That Met QC Criteria

March 11, 2005

First Posted (Estimate)

March 14, 2005

Study Record Updates

Last Update Posted (Estimate)

May 24, 2010

Last Update Submitted That Met QC Criteria

May 20, 2010

Last Verified

May 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CR002281

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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