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NCT Number: NCT00396565

A Study to Evaluate Effectiveness and Safety of ER OROS Paliperidone in Patients With Schizophrenia

The purpose of this study is to evaluate the effectiveness and safety of Extended Release Osmotic Controlled-Release Oral Delivery System (OROS) Paliperidone compared to placebo in patients with Schizophrenia. Olanzapine will be used as a reference drug in the study.

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Key information

Conditions

Schizophrenia Mental Disorders Schizophrenia Spectrum and Other Psychotic Disorders

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Aizu-Wakamatsu, Japan

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About this study

This is a multicenter, double blind (neither the patient nor the physician knows whether drug or placebo is being taken, or at what dosage), randomized (patients are assigned different treatments based on chance), placebo- and active-controlled, parallel-group study. Patients will be randomized into 1 of 3 treatment groups to receive oral dosages of Extended Release (ER) Osmotic Controlled-Release Oral Delivery System (OROS) paliperidone 6 mg, olanzapine 10 mg, or placebo. They will receive two capsules of Paliperidone ER 3 mg, placebo or Olanzapine 5 mg once daily after breakfast for 6 weeks. The study will include a screening period, followed by double-blind treatment for 6 weeks.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients who have given their own consent in writing to participate in the study
  • Patients diagnosed with schizophrenia according to the diagnostic criteria of DSM-IV (Diagnostic and Statistical Manual of Mental Disorders, 295.30, 295.10, 295.20, 295.90, 295.60)
  • Patients who have acute symptoms of schizophrenia
  • Both inpatients and outpatients are acceptable

Exclusion criteria

  • A DSM-IV (Diagnostic and Statistical Manual of Mental Disorders) of a mental disease diagnosis other than schizophrenia
  • A DSM-IV diagnosis of substance-related disorder (except nicotine dependence and caffeine dependence) within 180 days before the screening test
  • Total PANSS (Positive and Negative Syndrome System) score at the screening test <70 or >120
  • Patients treated with three or more types of antipsychotic within 28 days before the screening test
  • Parkinson's disease (except for those with drug-induced extra pyramidal symptoms)
  • Patients with a complication of or a past history of cerebrovascular accident
  • Patients with a complication of or a past history of diabetes mellitus

Treatment and study plan

ER OROS paliperidone

Drug

Type= exact number, unit= mg, number= 3, form= tablet, route= oral use. Two tablets once daily for 6 weeks.

Placebo

Drug

Form= tablet, route= oral use. Two tablets once daily for 6 weeks.

Olanzapine

Drug

Type= exact number, unit= mg, number= 2.5, form= tablet, route= oral use. Four tablets once daily for 6 weeks.

Primary outcomes

  1. Change From Baseline in the Total Positive and Negative Syndrome Scale (PANSS).

    Time frame: Baseline and 6 weeks

    PANSS is a medical scale that assesses various symptoms of schizophrenia. The symptoms are rated on a 7-point scale from 1 (absent) to 7 (extreme psychopathology). The total score is the sum of all 30 PANSS items, with a range of 30 (absent) to 210 (extreme ill).

Secondary outcomes

  1. Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Positive Subscale Score

    Time frame: Baseline and 6 weeks

    The PANSS Positive Subscale assesses seven positive-symptoms of schizophrenia. Positive symptoms refer to an excess or distortion of normal functions. The symptoms are rated on a 7-point scale, with a range of 7 (absent) to 49 (extreme psychopathology).

  2. Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Negative Subscale Score

    Time frame: Baseline and 6 weeks

    The PANSS Negative Subscale assesses seven negative-symptoms of schizophrenia. Negative symptoms represent a diminution or loss of normal functions. The symptoms are rated on a 7-point scale, with a range of 7 (absent) to 49 (extreme psychopathology).

  3. Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - General Psychopathology Subscale Score

    Time frame: Baseline and 6 weeks

    The PANSS General Psychopathology Subscale Score assesses 16 general psychopathology symptoms. The symptoms are rated on a 7-point scale, with a range of 16 (absent) to 112 (extreme psychopathology).

  4. Proportion of Responders (≥30% Decrease in Total Positive and Negative Syndrome Scale [PANSS])

    Time frame: Baseline and 6 weeks

    Responders are subjects with 30% or more reduction from baseline in total PANSS score. PANSS is a medical scale that assesses various symptoms of schizophrenia. The symptoms are rated on a 7-point scale from 1 (absent) to 7 (extreme psychopathology). The total score is the sum of all 30 PANSS items, with a range of 30 (absent) to 210 (extreme ill).

  5. Change From Baseline in Clinical Global Impression Scale (CGI-S)

    Time frame: Baseline and 6 weeks

    The CGI-S rating scale is a 7-point global assessment with scores as follows: 1 - Not ill, 2 - Very Mild, 3 - Mild, 4 - Moderate, 5 - Marked, 6 - Severe, and 7 - Extremely Severe.

Sponsors and collaborators

Lead sponsor

Janssen Pharmaceutical K.K.

Industry

Registry information

Official study title

A Placebo-Controlled Double Blind Comparative Study of JNS007ER in Patients With Schizophrenia

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Nov 7, 2006
Registry last updated
Apr 29, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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