Trial Evaluating Paliperidone Extended-Release (ER) Tablets Versus Placebo on Sleep in Schizophrenia Patients
Condition: Schizophrenia; Insomnia
MeSH terms: Sleep Initiation and Maintenance Disorders; Schizophrenia
Study type: Interventional
Phase: Phase 2

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 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
    

Intervention name(s): paliperidone ER
Intervention type(s): Drug
Intervention MeSH terms: Paliperidone Palmitate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Schizophrenia; Schizophrenia-related insomnia; insomnia; paliperidone; placebo; polysomnography