Status:
COMPLETED
A Randomized, Active-controlled, Double-blind, Parallel-Goup Study of the Efficacy and Safety of Extended Release(ER) Paliperidone in the Treatment of Schizophrenia
Lead Sponsor:
Xian-Janssen Pharmaceutical Ltd.
Conditions:
Acute Schizophrenia
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief Summary
This is a randomized (patients are assigned different treatments based on chance), double-blind (neither the patient nor the physician knows whether drug or placebo is being taken, or at what dosage),...
Detailed Description
The study hypothesis is that the effect of extended release OROS paliperidone is not worse than that of Olanzapine in the treatment of schizophrenia as measured by the change in PANSS from baseline to...
Eligibility Criteria
Inclusion
- Patients (or their legally acceptable representatives) must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study
- DSM-IV diagnosis of schizophrenia (295.10, 295.20, 295.30, 295.60, 295.90) at entry
- Total PANSS score at screening and baseline between 60 and 120, inclusive
- Female patients must be postmenopausal for at least 1 year, surgically sterile, or practicing an effective method of birth control (e.g., prescription oral contraceptives, contraceptive injections, intrauterine device, double-barrier method, contraceptive patch) before entry (and agree to continue that method throughout the study) - abstinence is not an acceptable method
- have a negative urine b hCG pregnancy test at screening
- Capable of self-administering study drug, or has consistent help and support available throughout the study to do this
Exclusion
- A DSM-IV (Diagnostic and Statistical Manual of Mental Disorders) Axis I diagnosis other than schizophrenia
- Inability to swallow the study drug whole with the aid of water (participants may not chew, divide, dissolve, or crush the study drug, as this may affect the release profile)
- Previous history of a lack of response to any antipsychotic (lack of response defined as subject having had least twice a documented medical history of no clinical response despite adequate doses and durations of treatment, or the inability to tolerate effective doses)
- Significant risk of suicidal or violent behavior
- Injection of a depot antipsychotic within 120 days before screening, or use of paliperidone palmitate within 10 months before screening
- Use of monoamine oxidase inhibitors within 4 weeks before screening
- Use of antidepressants other than monoamine oxidase inhibitors or mood stabilizers (e.g., antiepileptics, lithium) within 2 weeks before screening
- Received electroconvulsive therapy within 3 months before screening
Key Trial Info
Start Date :
June 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2007
Estimated Enrollment :
288 Patients enrolled
Trial Details
Trial ID
NCT00350467
Start Date
June 1 2006
End Date
September 1 2007
Last Update
May 19 2011
Active Locations (7)
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1
Beijing, Beijing Municipality, China
2
Guangzhou, Guangdong, China
3
Wuhan, Hubei, China
4
Nanjing, Jiangsu, China