A Study to Evaluate Flexible Dose of Paliperidone ER and Clinical Response in the Treatment of Patients With Schizophrenia
The purpose of this study is to evaluate the effectiveness of paliperidone ER for the treatment of schizophrenia patients.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||An Open Label, Prospective, Non-Comparative Study to Evaluate Flexible Dose of Paliperidone ER and Clinical Response in the Treatment of Subjects With Schizophrenia|
- The change from baseline in Clinical Global Impression-improvement (CGI-I) [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]CGI-I rating scale rates the change in the patient's mental state on a 7-point scale rating from 1 (very much improved) to 7 (very much worse) compared with baseline.
- The change from baseline in Clinical Global Impression-severity (CGI-S) [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]The CGI-S rating scale is used to rate the severity of a patient's psychotic condition on a 7-point scale ranging from 1 (not ill) to 7 (extremely severe).
- The proportion of patients who evaluated as "1.Very much improved" or "2.Much improved" on the CGI-I Scale [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- The change from baseline in Personal and Social Performance Scale (PSP) [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]The PSP scale measures the degree of disability the patient expresses in four domains of behavior: socially useful activities, personal and social relationships; self-care, and disturbing and aggressive behaviors. It is a 100-point rating scale, subdivided into 10 equal intervals to define the degree of disability. The patients with 71~100 points show mild difficulty and the patients with ≤ 30 points function so poorly that they require active care.
- Drug Attitude Inventory (DAI-10) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]Drug Attitude Inventory is a 10-item questionnaire to assess 1) subjective experience of drug and 2) attitudes and beliefs toward neuroleptics which may influence compliance in schizophrenia patients. Respondents must indicate 'true' or 'false' for each item.
|Study Start Date:||May 2008|
|Study Completion Date:||April 2009|
|Primary Completion Date:||April 2009 (Final data collection date for primary outcome measure)|
|Experimental: Paliperidone ER||
Drug: Paliperidone ER
Type= exact number, unit= mg, number= 6, form= tablet, route= oral use. Paliperidone ER 6 mg once daily.
This is a multi-center, open-label (all people know the identity of the intervention), prospective, non-comparative study. This clinical study is composed of the screening period and 12-week treatment phase. The effectiveness of paliperidone Extended-Release (ER) will be evaluated at week 12 by the proportion of responders who evaluated as "very much improved" or "much improved" on the Clinical Global Impression improvement (CGI-I) Scale.