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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00396565
First Posted: November 7, 2006
Last Update Posted: April 29, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Janssen Pharmaceutical K.K.
  Purpose
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.

Condition Intervention Phase
Schizophrenia Drug: ER OROS paliperidone Drug: Placebo Drug: Olanzapine Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Placebo-Controlled Double Blind Comparative Study of JNS007ER in Patients With Schizophrenia

Resource links provided by NLM:


Further study details as provided by Janssen Pharmaceutical K.K.:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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).

  • 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).

  • 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).

  • 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).

  • 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.


Enrollment: 394
Study Start Date: July 2006
Study Completion Date: November 2007
Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ER OROS paliperidone
Extended Release (ER) Osmotic Controlled-Release Oral Delivery System (OROS) paliperidone
Drug: ER OROS paliperidone
Type= exact number, unit= mg, number= 3, form= tablet, route= oral use. Two tablets once daily for 6 weeks.
Placebo Comparator: Placebo Drug: Placebo
Form= tablet, route= oral use. Two tablets once daily for 6 weeks.
Active Comparator: Olanzapine Drug: Olanzapine
Type= exact number, unit= mg, number= 2.5, form= tablet, route= oral use. Four tablets once daily for 6 weeks.

Detailed Description:
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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00396565


  Show 56 Study Locations
Sponsors and Collaborators
Janssen Pharmaceutical K.K.
Investigators
Study Director: Janssen Pharmaceutical K.K. Clinical Trial Janssen Pharmaceutical K.K.
  More Information

Additional Information:
Responsible Party: Janssen Pharmaceutical K.K.
ClinicalTrials.gov Identifier: NCT00396565     History of Changes
Other Study ID Numbers: CR012625
JNS007ER-JPN-S31 ( Other Identifier: Janssen Pharmaceutical K.K., Japan )
First Submitted: November 3, 2006
First Posted: November 7, 2006
Results First Submitted: March 27, 2012
Results First Posted: July 3, 2012
Last Update Posted: April 29, 2014
Last Verified: April 2014

Keywords provided by Janssen Pharmaceutical K.K.:
Schizophrenia
JNS007ER
Positive and Negative Syndrome Scale (PANSS)
Paliperidone
Extended Release Osmotic Controlled-Release Oral Delivery System (OROS) paliperidone

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Olanzapine
Paliperidone Palmitate
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Serotonin 5-HT2 Receptor Antagonists
Serotonin Antagonists
Dopamine D2 Receptor Antagonists
Dopamine Antagonists
Dopamine Agents