Status:
COMPLETED
A Study to Evaluate Effectiveness and Safety of ER OROS Paliperidone in Patients With Schizophrenia
Lead Sponsor:
Janssen Pharmaceutical K.K.
Conditions:
Schizophrenia
Eligibility:
All Genders
20+ years
Phase:
PHASE3
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 Schiz...
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 base...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2007
Estimated Enrollment :
394 Patients enrolled
Trial Details
Trial ID
NCT00396565
Start Date
July 1 2006
End Date
November 1 2007
Last Update
April 29 2014
Active Locations (56)
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1
Aizu-Wakamatsu, Japan
2
Fujioka, Japan
3
Fujisawa, Japan
4
Fukui, Japan