A Study to Evaluate Flexible Dose of Paliperidone Extended Release (ER) and Clinical Response in Participants With Schizophrenia
The purpose of this study is to evaluate the effectiveness of paliperidone ER for the treatment of schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self) participants.
|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|
- Percentage of Responders as Per Clinical Global Impression - Improvement (CGI-I) Scale [ Time Frame: Week 12 ] [ Designated as safety issue: No ]The CGI-I is a 7-point scale that requires the clinician to assess how much the participant's illness has improved or worsened relative to a baseline state at the beginning of the intervention and rated as: 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse. Responders were defined as participants evaluated as "1: very much improved" or "2: much improved" on the CGI-I scale at Week 12.
- Change From Baseline in Clinical Global Impression - Severity (CGI-S) Score at Week 12 [ Time Frame: Baseline, Week 12 ] [ Designated as safety issue: No ]The CGI-S rating scale is a 7 point global assessment that measures the clinician's impression of the severity of illness exhibited by a participant. A rating of 1 is equivalent to "Normal, not at all ill" and a rating of 7 is equivalent to "Among the most extremely ill participants". Higher scores indicate worsening.
- Number of Participants With Clinical Global Impression - Improvement (CGI-I) Score [ Time Frame: Week 12 ] [ Designated as safety issue: No ]The CGI-I is a 7-point scale that requires the clinician to assess how much the participant's illness has improved or worsened relative to a baseline state at the beginning of the intervention and rated as: 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse.
- Change From Baseline in Personal and Social Performance (PSP) Score at Week 12 [ Time Frame: Baseline, Week 12 ] [ Designated as safety issue: No ]The PSP is 100-point validated clinician-rated scale that assesses degree of difficulty in 4 areas of functioning: socially useful activities, personal and social relationships, self-care, disturbing and aggressive behaviors rated on 6-point scale (1=absent to 6=very severe).Total transformed score from 1 to 100 is generated from raw score based on clinical interpretation of scores generated in 4 areas of functioning, with higher transformed score indicating better function. Total score is divided into 3 levels: 71-100 (mild difficulty); 31-70 (marked difficulty) and 1-30 (severe difficulty).
- Change From Baseline in Drug Attitude Inventory (DAI-10) Score at Week 12 [ Time Frame: Baseline, Week 12 ] [ Designated as safety issue: No ]The DAI-10 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 participants. It is the binary scale assessing the participant's subjective response (SR). A 'compliant' response is scored as +1; a dysphoric response is scored as -1. A positive sum of items indicates a positive SR; a negative sum of scores indicates a negative SR (non-compliant). The final score is the grand total of the positive and negative points. Total score ranges from (-) 10 to (+) 10, higher score indicates positive SR (compliant) and lower score indicates negative SR (non-compliant).
|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 Extended Release (ER)||
Drug: Paliperidone ER
Participants will receive paliperidone ER 6 milligram (mg) orally once daily up to Week 12. Dose adjustment will be done at Week 2, 4 and 8 as per investigator's discretion based upon participant's CGI-I score.
This is a multi-center (when more than one hospital or medical school team work on a medical research study), open-label (all people know the identity of the intervention), prospective (study following participants forward in time), non-comparative study. The total study duration will be 12 weeks for each participant and will include following visits: Screening, Week 2, 4, 8, and 12 (end of treatment or early withdrawal). The effectiveness of paliperidone ER will be evaluated at Week 12 by the proportion of responders who are evaluated as "very much improved" or "much improved" on the Clinical Global Impression improvement (CGI-I) Scale. Participants' safety will also be monitored throughout the study.