Paliperidone Extended Release(ER) Effectiveness Study to Evaluate the Objective Symptom Change and Symptomatic Remission (PERFECT)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Janssen Korea, Ltd., Korea
ClinicalTrials.gov Identifier:
NCT00761579
First received: September 25, 2008
Last updated: May 1, 2014
Last verified: May 2014
Results First Received: January 16, 2014  
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

  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 Paliperidone oral tablet was administered once daily at a starting dose of either 3 milligram (mg) for 48 weeks, wherein recommended dose was 6 mg and dose range was 3 to 12 mg per day.

Participant Flow:   Overall Study
    Paliperidone  
STARTED     190  
COMPLETED     98  
NOT COMPLETED     92  
Adverse Event                 10  
Death                 2  
Lack of Efficacy                 21  
Lost to Follow-up                 16  
Pregnancy                 1  
Withdrawal by Subject                 34  
Lack of compliance                 2  
Protocol deviation                 1  
Drug overdose                 1  
Aggravation of depression                 1  
Aggravation of symptoms by changing drug                 1  
Lost survey form                 1  
Intake of prohibited concomitant drug                 1  



  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 Paliperidone oral tablet was administered once daily at a starting dose of either 3 milligram (mg) for 48 weeks, wherein recommended dose was 6 mg and dose range was 3 to 12 mg per day.

Baseline Measures
    Paliperidone  
Number of Participants  
[units: participants]
  190  
Age  
[units: years]
Mean ± Standard Deviation
  33.9  ± 10.54  
Gender  
[units: participants]
 
Female     93  
Male     97  
Positive and Negative Syndrome Scale (PANSS) Total Score [1]
[units: Units on a scale]
Mean ± Standard Deviation
  79.42  ± 19.64  
Positive and Negative Syndrome Scale (PANSS) - Positive Subscale Score [2]
[units: Units on a scale]
Mean ± Standard Deviation
  18.96  ± 6.19  
Positive and Negative Syndrome Scale (PANSS) - Negative Subscale Score [3]
[units: Units on a scale]
Mean ± Standard Deviation
  20.61  ± 5.97  
Positive and Negative Syndrome Scale (PANSS) - General Psychopathology Subscale Score [4]
[units: Units on a scale]
Mean ± Standard Deviation
  18.00  ± 5.56  
Personal and Social Performance Scale (PSP) Score [5]
[units: Units on a scale]
Mean ± Standard Deviation
  54.08  ± 14.84  
Drug Attitude Inventory (DAI-10) [6]
[units: Units on a scale]
Mean ± Standard Deviation
  3.01  ± 4.31  
Subjective Well-being Under Neuroleptic (SWN-20) Scale Score [7]
[units: Units on a scale]
Mean ± Standard Deviation
  73.64  ± 16.87  
Daytime Drowsiness [8]
[units: Units on a scale]
Mean ± Standard Deviation
  45.65  ± 29.97  
Sleep Quality [9]
[units: Units on a scale]
Mean ± Standard Deviation
  61.90  ± 27.73  
Symptom Checklist 90-R (SCL90-R) [10]
[units: Units on a scale]
Mean ± Standard Deviation
  91.72  ± 65.10  
[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 seven 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).
[3] 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).
[4] The PANSS General Psychopathology Subscale Score assesses 16 general psychopathology symptoms. The symptoms are rated on a 7-point scale, with a range of 16 (absent) to 112 (extreme psychopathology).
[5] 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).
[6] 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. A 'compliant' response is scored as +1; a dysphoric response is scored as -1. A positive sum of items indicates a positive subjective response (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.
[7] The SWN-20 scale is a 20 item scale that was originally designed to explore the subjective experience of psychotic participants. The SWN scale contains five sub-scales consisting of four items each: mental functioning (MF), self-control (SC), emotional regulation (ER), and social integration (SI), physical functioning (PF). The total score ranges from a minimum of 20 (poor subjective experience) to a maximum of 120 (excellent subjective experience). SWN scores appear to correlate with measure of objective psychopathology, quality of life and other self-ratings of mood.
[8] Daytime Drowsiness was assessed by an 11-point visual analog scale. Participants indicated on the 11-point visual analog scale (score ranging from 0 to 100 millimeter) how well they have slept in the previous 7 days, from 0 (very badly) to 100 (very well); and how often they have felt drowsy within the previous 7 days, from 0 (not at all) to 100 (all the time). Scores were averaged for the previous 7 days.
[9] Sleep quality was assessed by an 11-point visual analog scale. Participants indicated on the 11-point visual analog scale (score ranging from 0 to 100 millimeter) how well they have slept in the previous 7 days, from 0 (very badly) to 100 (very well); and how often they have felt drowsy within the previous 7 days, from 0 (not at all) to 100 (all the time). Scores were averaged for the previous 7 days.
[10] The SCL90-R (Derogatis, 1992) measures 9 domains, including somatization, obsessive-compulsive, interpersonal sensitivity, depression, anxiety, hostility, phobic anxiety, paranoid ideation, psychoticism, which provides a global index of distress, the Global Severity Index (GSI). SCL-90-R includes 90 items rated on 5-point scale, ranging from 0 (not at all) to 4 (extremely). Total scale score range from 0 to 360. Higher scores indicate worsening of disease.



  Outcome Measures
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1.  Primary:   Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 48   [ Time Frame: Baseline and Week 48 ]

2.  Primary:   Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Positive Subscale Score at Week 48   [ Time Frame: Baseline and Week 48 ]

3.  Primary:   Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Negative Subscale Score at Week 48   [ Time Frame: Baseline and Week 48 ]

4.  Primary:   Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - General Psychopathology Subscale Score at Week 48   [ Time Frame: Baseline and Week 48 ]

5.  Secondary:   Change From Baseline in Personal and Social Performance Scale (PSP) Score at Week 48   [ Time Frame: Baseline and Week 48 ]

6.  Secondary:   Change From Baseline in Drug Attitude Inventory (DAI-10) at Week 48   [ Time Frame: Baseline and Week 48 ]

7.  Secondary:   Change From Baseline in Subjective Well-being Under Neuroleptic (SWN-20) Scale Score at Week 48   [ Time Frame: Baseline and Week 48 ]

8.  Secondary:   Change From Baseline in Daytime Drowsiness at Week 48   [ Time Frame: Baseline and Week 48 ]

9.  Secondary:   Change From Baseline in Sleep Quality at Week 48   [ Time Frame: Baseline and Week 48 ]

10.  Secondary:   Change From Baseline in Symptom Checklist 90-R (SCL90-R) at Week 48   [ Time Frame: Baseline and Week 48 ]


  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: Senior Clinical Research Associate
Organization: Clinical Research Team, Medical Affairs Korea
phone: 82-2094-4804


No publications provided


Responsible Party: Janssen Korea, Ltd., Korea
ClinicalTrials.gov Identifier: NCT00761579     History of Changes
Other Study ID Numbers: CR015250, PAL-KOR-4002
Study First Received: September 25, 2008
Results First Received: January 16, 2014
Last Updated: May 1, 2014
Health Authority: Korea: Food and Drug Administration
Republic of Korea: Food and Drug Administration