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

This study has been completed.
Sponsor:
Information provided by:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier:
NCT00105326
First received: March 11, 2005
Last updated: May 20, 2010
Last verified: May 2010
  Purpose

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.


Condition Intervention Phase
Schizophrenia
Insomnia
Drug: paliperidone ER
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:

Primary Outcome Measures:
  • 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:
  • 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.

Enrollment: 5
Study Start Date: February 2005
Study Completion Date: August 2005
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

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00105326

Sponsors and Collaborators
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Investigators
Study Director: Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
  More Information

No publications provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00105326     History of Changes
Other Study ID Numbers: CR002281
Study First Received: March 11, 2005
Last Updated: May 20, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:
Schizophrenia
Schizophrenia-related insomnia
insomnia
paliperidone
placebo
polysomnography

Additional relevant MeSH terms:
Schizophrenia
Sleep Initiation and Maintenance Disorders
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases
9-hydroxy-risperidone
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs

ClinicalTrials.gov processed this record on April 17, 2014