A Study to Evaluate Flexible Dose of Paliperidone Extended Release (ER) and Clinical Response in Participants With Schizophrenia
|ClinicalTrials.gov Identifier: NCT01577160|
Recruitment Status : Completed
First Posted : April 13, 2012
Results First Posted : January 14, 2014
Last Update Posted : January 14, 2014
|Condition or disease||Intervention/treatment||Phase|
|Schizophrenia||Drug: Paliperidone ER||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||353 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||May 2008|
|Actual Primary Completion Date :||April 2009|
|Actual Study Completion Date :||April 2009|
|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.
- Percentage of Responders as Per Clinical Global Impression - Improvement (CGI-I) Scale [ Time Frame: Week 12 ]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 ]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 ]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 ]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 ]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).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01577160
|Study Director:||Johnson & Johnson Taiwan Ltd Clinical Trial||Johnson & Johnson Taiwan Ltd|