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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
394
Type= exact number, unit= mg, number= 3, form= tablet, route= oral use. Two tablets once daily for 6 weeks.
Form= tablet, route= oral use. Two tablets once daily for 6 weeks.
Type= exact number, unit= mg, number= 2.5, form= tablet, route= oral use. Four tablets once daily for 6 weeks.
Change From Baseline in the Total Positive and Negative Syndrome Scale (PANSS).
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).
Time frame: Baseline and 6 weeks
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Positive Subscale Score
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).
Time frame: Baseline and 6 weeks
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Negative Subscale Score
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).
Time frame: Baseline and 6 weeks
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - General Psychopathology Subscale Score
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).
Time frame: Baseline and 6 weeks
Proportion of Responders (≥30% Decrease in Total Positive and Negative Syndrome Scale [PANSS])
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).
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Unnamed facility
Aizu-Wakamatsu, Japan
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Fujioka, Japan
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Fujisawa, Japan
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Fukui, Japan
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Hadano, Japan
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Himeji, Japan
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Hiratsuka, Japan
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Hiroshima, Japan
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Ibaraki, Japan
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Ichikawa, Japan
...and 46 more locations
Time frame: Baseline and 6 weeks
Change From Baseline in Clinical Global Impression Scale (CGI-S)
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.
Time frame: Baseline and 6 weeks