Status:
COMPLETED
PaliperidoNe Extended-Release [ER] Dosing and Clinical Response in Acute Schizophrenia
Lead Sponsor:
Janssen Korea, Ltd., Korea
Conditions:
Schizophrenia
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief Summary
The purpose of this study is to evaluate the efficacy of paliperidone extended-release (ER) in participants with schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment ...
Detailed Description
This is an open-label (all people know the identity of the intervention), multi-centric (conducted in more than one center), prospective (study following participants forward in time), single arm, and...
Eligibility Criteria
Inclusion
- Participants with Clinical Global Impression-Severity (CGI-S) score greater than or equal to 4 points (moderately ill) at Screening
- Childbearing potential women who consent to the consistent use of the acceptable contraception (oral contraceptive, contraceptive injection, intrauterine device, double barrier method and contraceptive patch)
- Participants who are capable of and willing to fill out the questionnaire for themselves
- Participants who are compliant with self-medication or can receive consistent help or support
- Have schizophrenia diagnosis by Diagnostic and Statistical Manual of Mental Disorders, fourth edition (DSM-IV)
Exclusion
- Participants with the past history of neuroleptic malignant syndrome (NMS)
- Participants with Treatment Resistance history who have failed to be properly treated with more than two other kinds of antipsychotic agents (at least 4 weeks of the therapeutic dose administration)
- Participants with severe (pathologic or iatrogenic) gastrointestinal stenosis or participants who can not swallow the drug whole (The study drug must not be chewed, divided, melted or grinded because it can impact the study drug release profile.)
- Participants who have been exposed to the study drug within one month before screening
- Participants with significant risk including suicide or aggressive behavior
Key Trial Info
Start Date :
February 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2010
Estimated Enrollment :
491 Patients enrolled
Trial Details
Trial ID
NCT00761189
Start Date
February 1 2008
End Date
July 1 2010
Last Update
March 5 2014
Active Locations (20)
Enter a location and click search to find clinical trials sorted by distance.
1
Bucheon-Si Gyeonggi-Do, South Korea
2
Changnyung, South Korea
3
Chunjoo, South Korea
4
Daejeon, South Korea