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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Johnson & Johnson Taiwan Ltd
ClinicalTrials.gov Identifier:
NCT01577160
First received: April 12, 2012
Last updated: November 25, 2013
Last verified: November 2013
Results First Received: November 25, 2013  
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Schizophrenia
Intervention: Drug: Paliperidone ER

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Paliperidone ER 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.

Participant Flow:   Overall Study
    Paliperidone ER  
STARTED     353  
COMPLETED     255  
NOT COMPLETED     98  
Adverse Event                 9  
Lack of Efficacy                 15  
Lost to Follow-up                 40  
Withdrawal by Subject                 18  
Subject Uncooperative                 7  
Unspecified                 9  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Paliperidone ER 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.

Baseline Measures
    Paliperidone ER  
Number of Participants  
[units: participants]
  353  
Age  
[units: years]
Mean ± Standard Deviation
  41.1  ± 11.2  
Gender  
[units: participants]
 
Female     132  
Male     221  



  Outcome Measures
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1.  Primary:   Percentage of Responders as Per Clinical Global Impression - Improvement (CGI-I) Scale   [ Time Frame: Week 12 ]

2.  Secondary:   Change From Baseline in Clinical Global Impression - Severity (CGI-S) Score at Week 12   [ Time Frame: Baseline, Week 12 ]

3.  Secondary:   Number of Participants With Clinical Global Impression - Improvement (CGI-I) Score   [ Time Frame: Week 12 ]

4.  Secondary:   Change From Baseline in Personal and Social Performance (PSP) Score at Week 12   [ Time Frame: Baseline, Week 12 ]

5.  Secondary:   Change From Baseline in Drug Attitude Inventory (DAI-10) Score at Week 12   [ Time Frame: Baseline, Week 12 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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.


  More Information
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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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI 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


No publications provided


Responsible Party: Johnson & Johnson Taiwan Ltd
ClinicalTrials.gov Identifier: NCT01577160     History of Changes
Other Study ID Numbers: CR015664, R076477SCH4034, PAL-TWN-MA2
Study First Received: April 12, 2012
Results First Received: November 25, 2013
Last Updated: November 25, 2013
Health Authority: Taiwan : Food and Drug Administration