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

Phase 3

Completed

• Conditions: Schizophrenia
• Interventions: Drug: ER OROS paliperidone; Drug: Placebo; Drug: Olanzapine

• Registration Number: NCT00396565
• Lead Sponsor: Janssen Pharmaceutical K.K.

Brief Summary

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.

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.

Study Timeline

• Study Start: 2006-07
• Study First Submitted: 2006-11-03
• Study First Submitted QC: 2006-11-03
• Study First Posted: 2006-11-07
• Primary Completion: 2007-11
• Study Completion: 2007-11
• Results First Submitted: 2012-03-27
• Results First Submitted QC: 2012-05-30
• Results First Posted: 2012-07-03
• Status Verified: 2014-04
• Last Update Submitted: 2014-04-10
• Last Update Posted: 2014-04-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 394

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ER OROS paliperidone	ER OROS paliperidone	Extended Release (ER) Osmotic Controlled-Release Oral Delivery System (OROS) paliperidone
Placebo	Placebo	-
Olanzapine	Olanzapine	-

Primary Outcome Measures

Name	Time	Method
Change From Baseline in the Total Positive and Negative Syndrome Scale (PANSS).	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

Name	Time	Method
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Positive Subscale Score	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	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	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])	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)	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.