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A Study to Evaluate Flexible Dose of Paliperidone Extended Release (ER) and Clinical Response in Participants With Schizophrenia

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ClinicalTrials.gov Identifier: NCT01577160
Recruitment Status : Completed
First Posted : April 13, 2012
Results First Posted : January 14, 2014
Last Update Posted : January 14, 2014
Sponsor:
Information provided by (Responsible Party):
Johnson & Johnson Taiwan Ltd

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Schizophrenia
Intervention Drug: Paliperidone ER
Enrollment 353
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Paliperidone ER
Hide Arm/Group Description Participants received paliperidone ER 6 milligram (mg) orally once daily up to Week 12. Dose adjustment was done at Week 2, 4 and 8 as per Investigator’s discretion based upon participant’s Clinical Global Impression - Improvement (CGI-I) score.
Period Title: Overall Study
Started 353
Completed 255
Not Completed 98
Reason Not Completed
Adverse Event             9
Lack of Efficacy             15
Lost to Follow-up             40
Withdrawal by Subject             18
Subject Uncooperative             7
Other             9
Arm/Group Title Paliperidone ER
Hide Arm/Group Description Participants received paliperidone ER 6 milligram (mg) orally once daily up to Week 12. Dose adjustment was done at Week 2, 4 and 8 as per Investigator’s discretion based upon participant’s CGI-I score.
Overall Number of Baseline Participants 353
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 353 participants
41.1  (11.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 353 participants
Female
132
  37.4%
Male
221
  62.6%
1.Primary Outcome
Title Percentage of Responders as Per Clinical Global Impression - Improvement (CGI-I) Scale
Hide Description 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.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT) population included all participants who received at least 1 dose of study drug and had at least one post-baseline assessment. Here 'N' (Number of Participants Analyzed) signifies those participants evaluable for this measure.
Arm/Group Title Paliperidone Extended Release (ER)
Hide Arm/Group Description:
Participants received paliperidone ER 6 milligram (mg) orally once daily up to Week 12. Dose adjustment was done at Week 2, 4 and 8 as per Investigator’s discretion based upon participant’s CGI-I score.
Overall Number of Participants Analyzed 255
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
21.6
(16.68 to 27.13)
2.Secondary Outcome
Title Change From Baseline in Clinical Global Impression - Severity (CGI-S) Score at Week 12
Hide Description 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.
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants who received at least 1 dose of study drug and had at least one post-baseline assessment. Here, 'n' signifies those participants who were evaluable for this outcome measure at specified time point.
Arm/Group Title Paliperidone Extended Release (ER)
Hide Arm/Group Description:
Participants received paliperidone ER 6 milligram (mg) orally once daily up to Week 12. Dose adjustment was done at Week 2, 4 and 8 as per Investigator’s discretion based upon participant’s CGI-I score.
Overall Number of Participants Analyzed 331
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline (n=331) 5.0  (0.8)
Change at Week 12 (n=255) -1.4  (1.0)
3.Secondary Outcome
Title Number of Participants With Clinical Global Impression - Improvement (CGI-I) Score
Hide Description 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.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants who received at least 1 dose of study drug and had at least one post-baseline assessment. Here 'N' (Number of Participants Analyzed) signifies those participants evaluable for this measure.
Arm/Group Title Paliperidone Extended Release (ER)
Hide Arm/Group Description:
Participants received paliperidone ER 6 milligram (mg) orally once daily up to Week 12. Dose adjustment was done at Week 2, 4 and 8 as per Investigator’s discretion based upon participant’s CGI-I score.
Overall Number of Participants Analyzed 255
Measure Type: Number
Unit of Measure: participants
Very much improved 3
Much improved 52
Minimally improved 119
No change 67
Minimally worse 10
Much worse 2
Very much worse 2
4.Secondary Outcome
Title Change From Baseline in Personal and Social Performance (PSP) Score at Week 12
Hide Description 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).
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants who received at least 1 dose of study drug and had at least one post-baseline assessment. Here, 'n' signifies those participants who were evaluable for this outcome measure at specified time point.
Arm/Group Title Paliperidone Extended Release (ER)
Hide Arm/Group Description:
Participants received paliperidone ER 6 milligram (mg) orally once daily up to Week 12. Dose adjustment was done at Week 2, 4 and 8 as per Investigator’s discretion based upon participant’s CGI-I score.
Overall Number of Participants Analyzed 331
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline (n=331) 42.6  (14.9)
Change at Week 12 (n=267) 14.3  (13.0)
5.Secondary Outcome
Title Change From Baseline in Drug Attitude Inventory (DAI-10) Score at Week 12
Hide Description 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).
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants who received at least 1 dose of study drug and had at least one post-baseline assessment. Here, 'n' signifies those participants who were evaluable for this outcome measure at specified time point.
Arm/Group Title Paliperidone Extended Release (ER)
Hide Arm/Group Description:
Participants received paliperidone ER 6 milligram (mg) orally once daily up to Week 12. Dose adjustment was done at Week 2, 4 and 8 as per Investigator’s discretion based upon participant’s CGI-I score.
Overall Number of Participants Analyzed 331
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline (n=331) 2.5  (4.6)
Change at Week 12 (n=267) 1.0  (4.9)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Paliperidone ER
Hide Arm/Group Description Participants received paliperidone ER 6 milligram (mg) orally once daily up to Week 12. Dose adjustment was done at Week 2, 4 and 8 as per Investigator’s discretion based upon participant’s CGI-I score.
All-Cause Mortality
Paliperidone ER
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Paliperidone ER
Affected / at Risk (%)
Total   0/353 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
Paliperidone ER
Affected / at Risk (%)
Total   140/353 (39.66%) 
Gastrointestinal disorders   
Constipation * 1  40/353 (11.33%) 
General disorders   
Pyrexia * 1  8/353 (2.27%) 
Infections and infestations   
Nasopharyngitis * 1  18/353 (5.10%) 
Upper Respiratory Tract Infection * 1  18/353 (5.10%) 
Injury, poisoning and procedural complications   
Wound * 1  9/353 (2.55%) 
Nervous system disorders   
Extrapyramidal Disorder * 1  34/353 (9.63%) 
Headache * 1  9/353 (2.55%) 
Psychiatric disorders   
Anxiety * 1  25/353 (7.08%) 
Delusion * 1  8/353 (2.27%) 
Depression * 1  9/353 (2.55%) 
Insomnia * 1  56/353 (15.86%) 
Respiratory, thoracic and mediastinal disorders   
Cough * 1  13/353 (3.68%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA Version 12.0
Some Adverse Events summaries were reported based on estimates due to the fact that they were not prepared in the original study report and the relevant definitions of the data elements were not available for these summaries to be regenerated.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Medical Director
Organization: Janssen Research & Development
Phone: 886 2 23762155
Responsible Party: Johnson & Johnson Taiwan Ltd
ClinicalTrials.gov Identifier: NCT01577160     History of Changes
Other Study ID Numbers: CR015664
R076477SCH4034 ( Other Identifier: Johnson & Johnson Taiwan Ltd )
PAL-TWN-MA2 ( Other Identifier: Johnson & Johnson Taiwan Ltd )
First Submitted: April 12, 2012
First Posted: April 13, 2012
Results First Submitted: November 25, 2013
Results First Posted: January 14, 2014
Last Update Posted: January 14, 2014