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An Open-label, Prospective, Non-Comparative Study to Evaluate Subjective Well-Being and Responses in Patients With Schizophrenia Who Had Switched to Paliperidone Extended-Release Tablets
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 in participants with schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self).
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-comparative study, in participants with schizophrenia. The study consists of following parts: Screening (that is, 14 days before study commences on Day 1); Acute Treatment phase (24 weeks); Extension phase 1 (24 weeks), which will be followed by additional Extension phase 2 (48 weeks). Total study duration per participant will be 96 weeks. Efficacy will primarily be evaluated by change from Baseline in Subjective Well-being Under Neuroleptic (SWN-20) Scale score and change from Baseline in Drug Attitude Inventory scores. Participants' safety will be monitored throughout the study.
Age
18 - 65 years
Sex
ALL
Healthy Volunteers
No
Busan, South Korea
Changnyeong, South Korea
Chungcheongbuk-Do, South Korea
Daegu, South Korea
Daejeon, South Korea
Hwasun Gun, South Korea
Iksan, South Korea
Jeonju, South Korea
Junam, South Korea
Kwangjoo, South Korea
Start Date
April 1, 2008
Primary Completion Date
December 1, 2010
Completion Date
January 1, 2011
Last Updated
March 27, 2014
289
ACTUAL participants
Paliperidone
DRUG
Lead Sponsor
Janssen Korea, Ltd., Korea
NCT07455929
NCT06740383
Data Source & Attribution
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