A Study to Evaluate Effectiveness and Safety of ER OROS Paliperidone in Patients With Schizophrenia
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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 Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | A Placebo-Controlled Double Blind Comparative Study of JNS007ER in Patients With Schizophrenia |
- Change From Baseline in the Total Positive and Negative Syndrome Scale (PANSS). [ Time Frame: Baseline and 6 weeks ] [ Designated as safety issue: No ]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 Positive and Negative Syndrome Scale (PANSS) - Positive Subscale Score [ Time Frame: Baseline and 6 weeks ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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| Ages Eligible for Study: | 20 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Show 59 Study Locations| Study Director: | Janssen Pharmaceutical K.K. Clinical Trial | Janssen Pharmaceutical K.K. |
More Information
Additional Information:
No publications provided
| Responsible Party: | Janssen Pharmaceutical K.K. |
| ClinicalTrials.gov Identifier: | NCT00396565 History of Changes |
| Other Study ID Numbers: | CR012625, JNS007ER-JPN-S31 |
| Study First Received: | November 3, 2006 |
| Results First Received: | March 27, 2012 |
| Last Updated: | January 28, 2013 |
| Health Authority: | Japan: Japan Pharmaceuticals And Medical Devices Evaluation Center |
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 and Disorders with Psychotic Features Mental Disorders Olanzapine 9-hydroxy-risperidone Antipsychotic Agents Tranquilizing Agents Central Nervous System Depressants Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents |
Therapeutic Uses Psychotropic Drugs Serotonin Uptake Inhibitors Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Serotonin Agents Antiemetics Autonomic Agents Peripheral Nervous System Agents Gastrointestinal Agents |
ClinicalTrials.gov processed this record on June 18, 2013