Phase 3
Completed N=321
A Study to Evaluate Effectiveness and Safety of ER OROS Paliperidone in Patients With Schizophrenia
Source: ClinicalTrials.gov NCT00396565 ↗Enrolled (actual)
321
Serious AEs
2.2%
Results posted
Jul 2012
Primary outcomePrimary: Change From Baseline in the Total Positive and Negative Syndrome Scale (PANSS). — -9.1; 3.8; -9.9 scores on a scale — p=<0.0001
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in the Total Positive and Negative Syndrome Scale (PANSS). |
-9.1; 3.8; -9.9 | <0.0001 sig |
| SECONDARY Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Positive Subscale Score |
-2.6; 1.6; -2.4 | <0.0001 sig |
| SECONDARY Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Negative Subscale Score |
-2.4; 0.0; -2.8 | <0.0001 sig |
| SECONDARY Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - General Psychopathology Subscale Score |
-4.1; 2.2; -4.7 | <0.0001 sig |
| SECONDARY Proportion of Responders (≥30% Decrease in Total Positive and Negative Syndrome Scale [PANSS]) |
25.4; 9.4; 26.1 | 0.0007 sig |
| SECONDARY Change From Baseline in Clinical Global Impression Scale (CGI-S) |
-0.4; 0.2; -0.3 | <0.0001 sig |
Eligibility 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 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
Data sourced from ClinicalTrials.gov (NCT00396565). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.