A Study to Evaluate Participants Satisfaction, Quality of Life and Effectiveness of Flexible-Dose of Paliperidone Extended Release (ER) in Participants With Schizophrenia, Previously Treated With Risperidone

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Janssen-Cilag Farmaceutica Ltda.
ClinicalTrials.gov Identifier:
NCT01010776
First received: November 5, 2009
Last updated: September 17, 2013
Last verified: September 2013
Results First Received: April 15, 2013  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Schizophrenia
Intervention: Drug: Paliperidone Extended Release (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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Paliperidone Extended Release (ER) Paliperidone ER tablets in the flexible dose ranging from 3 to 12 milligram (mg) was administered orally once daily for 26 weeks of main phase and for additional 26 weeks of Extension Phase to participants who continued with Extension Phase. Dosage was adjusted as per the Investigator’s discretion.

Participant Flow for 3 periods

Period 1:   Main Phase
    Paliperidone Extended Release (ER)  
STARTED     223  
Treated     218  
COMPLETED     174  
NOT COMPLETED     49  
Withdrawal by Subject                 14  
Lack of Efficacy                 8  
Adverse Event                 7  
Lost to Follow-up                 6  
Non-compliance to study medication                 5  
Selection failure                 2  
Inform consent withdrawal                 1  
Not specified                 1  
Did not received study medication                 5  

Period 2:   In-Between Main Phase & Extension Phase
    Paliperidone Extended Release (ER)  
STARTED     174  
COMPLETED     159  
NOT COMPLETED     15  
Extension phase was optional                 15  

Period 3:   Extension Phase
    Paliperidone Extended Release (ER)  
STARTED     159  
COMPLETED     156  
NOT COMPLETED     3  
Not specified                 3  



  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.
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Reporting Groups
  Description
Paliperidone ER - Main Phase Plus Extension Phase Paliperidone ER tablets in the flexible dose ranging from 3 to 12 milligram (mg) was administered orally once daily for 26 weeks of main phase and for additional 26 weeks of Extension Phase to participants who continued with Extension Phase. Dosage was adjusted as per the Investigator’s discretion.

Baseline Measures
    Paliperidone ER - Main Phase Plus Extension Phase  
Number of Participants  
[units: participants]
  218  
Age  
[units: Years]
Mean ± Standard Deviation
  37.87  ± 11.01  
Age, Customized  
[units: Participants]
 
18-21 years     14  
22-29 years     50  
30-39 years     51  
40-49 years     67  
50-60 years     35  
61-69 years     1  
Gender  
[units: Participants]
 
Female     79  
Male     139  
Race/Ethnicity, Customized  
[units: Participants]
 
White/Caucasian     120  
Black     52  
Oriental     3  
Mulatto     9  
Brown     34  
Positive and Negative Syndrome Scale (PANSS) Total Score [1]
[units: Units on a scale]
Mean ± Standard Deviation
  94.49  ± 12.38  
Positive and Negative PANSS Subscales Score [2]
[units: Units on a scale]
Mean ± Standard Deviation
 
Positive PANSS Subscale Score     27.37  ± 6.48  
Negative PANSS Subscale Score     19.76  ± 5.79  
Personal and Social Performance (PSP) Scale Score [3]
[units: Units on a scale]
Mean ± Standard Deviation
  44.39  ± 13.11  
Pittsburg Sleep Quality Index (PSQI) [4]
[units: Units on a scale]
Mean ± Standard Deviation
  6.7  ± 4.1  
[1] The PANSS is a 30-item scale designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items and ranges from 30 to 210. Higher scores indicate worsening.
[2] The PANSS positive subscale assesses 7 positive-symptoms of schizophrenia. Positive symptoms refer to an excess or distortion of normal functions. The symptoms are rated on a 7-point scale, with a range of 7 (absent) to 49 (extreme psychopathology). The PANSS negative subscale assesses seven negative-symptoms of schizophrenia. Negative symptoms represent a diminution or loss of normal functions. The symptoms are rated on a 7-point scale, with a range of 7 (absent) to 49 (extreme psychopathology).
[3] The PSP assesses the degree of a participant’s dysfunction within 4 domains of behavior: socially useful activities, personal and social relationships, self-care, and disturbing and aggressive behavior. The score ranges from 1 to 100, divided into 10 equal intervals to rate the degree of difficulty (i, absent to vi, very severe) in each of the 4 domains. Based on the four domains there will be one total score. Participants with a score of 71 to 100 have a mild degree of difficulty; from 31 to 70, varying degrees of disability; =< 30, functioning so poorly as to require intensive supervision.
[4] The PSQI evaluates sleep behavior by means of 7 components: sleep quality, sleep latency, sleep duration, usual sleep efficiency, sleep disorders, use of sleep medication and daytime dysfunction. The sum of the 7 component scores produces a global score of subjective sleep quality that varies from 0 to 21, with higher scores indicating worse sleep quality.



  Outcome Measures
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1.  Primary:   Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 26 - Main Phase   [ Time Frame: Baseline and Week 26 ]

2.  Primary:   Change From Baseline in PANSS Total Score at Week 52 - Main Phase Plus Extension Phase   [ Time Frame: Baseline and Week 52 ]

3.  Secondary:   Percentage of Participants With Treatment Response in PANSS Total Score - Main Phase   [ Time Frame: Week 26 ]

4.  Secondary:   Percentage of Participants With Treatment Response in PANSS Total Score - Main Phase Plus Extension Phase   [ Time Frame: Week 52 ]

5.  Secondary:   Change From Baseline in Positive and Negative PANSS Subscales Score at Week 4, 8, 13 and 26 - Main Phase   [ Time Frame: Baseline, Week 4, 8, 13 and 26 ]

6.  Secondary:   Change From Baseline in Positive and Negative PANSS Subscales Score at Week 4, 8, 13, 26, 39 and 52 - Main Phase Plus Extension Phase   [ Time Frame: Baseline, Week 4, 8, 13, 26, 39 and 52 ]

7.  Secondary:   Change From Baseline in Personal and Social Performance (PSP) Scale Score at Week 4, 8, 13 and 26 - Main Phase   [ Time Frame: Baseline, Week 4, 8, 13 and 26 ]

8.  Secondary:   Change From Baseline in PSP Scale Score at Week 4, 8, 13, 26, 39 and 52 - Main Phase Plus Extension Phase   [ Time Frame: Baseline, Week 4, 8, 13, 26, 39 and 52 ]

9.  Secondary:   Change From Baseline in Pittsburg Sleep Quality Index (PSQI) Score at Week 4, 8, 13 and 26 - Main Phase   [ Time Frame: Baseline, Week 4, 8, 13 and 26 ]

10.  Secondary:   Change From Baseline PSQI Score at Week 4, 8, 13, 26, 39 and 52 - Main Phase Plus Extension Phase   [ Time Frame: Baseline, Week 4, 8, 13, 26, 39 and 52 ]

11.  Secondary:   Number of Participants With Clinical Global Impression–Severity (CGI-S) Score - Main Phase   [ Time Frame: Baseline, Week 4, 8, 13 and 26 ]

12.  Secondary:   Number of Participants With Clinical Global Impression–Severity (CGI-S) Score - Extension Phase   [ Time Frame: Week 39 and 52 ]

13.  Secondary:   Percentage of Participants With Treatment Satisfaction - Main Phase   [ Time Frame: Baseline, Week 4, 8, 13 and 26 ]

14.  Secondary:   Percentage of Participants With Treatment Satisfaction-Main Phase Plus Extension Phase   [ Time Frame: Baseline, Week 4, 8, 13, 26, 39 and 52 ]

15.  Secondary:   36-Item Short-Form Health Survey (SF-36) Score - Main Phase   [ Time Frame: Baseline and Week 26 ]

16.  Secondary:   36-Item Short-Form Health Survey (SF-36) Score - Main Phase Plus Extension Phase   [ Time Frame: Baseline and Week 52 ]

17.  Other Pre-specified:   Change From Baseline in Extrapyradimal Symptoms Rating Scale (ESRS) Total Score at Week 4, 8, 13 and 26 - Main Phase   [ Time Frame: Baseline, Week 4, 8, 13 and 26 ]

18.  Other Pre-specified:   Change From Baseline in ESRS Total Score at Week 4, 8, 13, 26, 39 and 52 - Main Phase Plus Extension Phase   [ Time Frame: Baseline, Week 4, 8, 13, 26, 39 and 52 ]


  Serious Adverse Events


  Other Adverse Events


  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 less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
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.


Limitations and Caveats
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
No text entered.  


Results Point of Contact:  
Name/Title: Medical Group Manager
Organization: Jan-Cil Brazil
phone: 55 11 3030-2770


No publications provided


Responsible Party: Janssen-Cilag Farmaceutica Ltda.
ClinicalTrials.gov Identifier: NCT01010776     History of Changes
Other Study ID Numbers: CR013744, R076477SCH4011
Study First Received: November 5, 2009
Results First Received: April 15, 2013
Last Updated: September 17, 2013
Health Authority: Brazil: National Health Surveillance Agency