Status:
COMPLETED
Efficacy Study of Paliperidone to Evaluate Subjective Change in Well-being and Drug Attitude in Schizophrenic Participants
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 improvement and efficacy of paliperidone extended-release for subjective well-being and drug attitudes of participants, when switching from oral antipsychotics...
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), and non-compara...
Eligibility Criteria
Inclusion
- Participants who are diagnosed with schizophrenia (diagnosis criteria: Diagnostic and Statistical Manual of Mental Disorders, fourth edition \[DSM-IV\])
- Participants who need to change the antipsychotic drug to another one for the following reasons among the participants treated with an antipsychotic drug for more than two weeks before the screening-Lack of efficacy, lack of tolerance or lack of compliance
- Participants who are capable of and willing to fill out the questionnaire for themselves
- Childbearing potential women who consent to the use of the consistently permissible contraception (oral contraceptive, contraceptive injection, intrauterine device, double barrier method and contraceptive patch)
- Participants who are compliant with self-medication or can receive consistent help or support
Exclusion
- Participants with the past history of neuroleptic malignant syndrome (NMS), or with allergy or hypersensitivity to risperidone or paliperidone
- Participants who have taken clozapine within one month before screening
- Participants who are suspicious of having clinically significant risk including suicide or aggressive behavior and are expected to unable to complete the study (based on the investigator's judgment)
- Participants with severe preexisting gastrointestinal narrowing (pathologic or iatrogenic) or participants who cannot 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 with a known or suspected history (for 6 months and longer) of substance dependence according to the DSM-IV criteria
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2011
Estimated Enrollment :
289 Patients enrolled
Trial Details
Trial ID
NCT00784238
Start Date
April 1 2008
End Date
January 1 2011
Last Update
March 27 2014
Active Locations (11)
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1
Busan, South Korea
2
Changnyeong, South Korea
3
Chungcheongbuk-Do, South Korea
4
Daegu, South Korea