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

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ClinicalTrials.gov Identifier: NCT00761579
Recruitment Status : Completed
First Posted : September 29, 2008
Results First Posted : June 3, 2014
Last Update Posted : June 3, 2014
Sponsor:
Information provided by (Responsible Party):
Janssen Korea, Ltd., Korea

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Schizophrenia
Intervention Drug: Paliperidone
Enrollment 190
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Paliperidone
Hide Arm/Group Description 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.
Period Title: Overall Study
Started 190
Completed 98
Not Completed 92
Reason Not Completed
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
Arm/Group Title Paliperidone
Hide Arm/Group Description 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.
Overall Number of Baseline Participants 190
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 190 participants
33.9  (10.54)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 190 participants
Female
93
  48.9%
Male
97
  51.1%
Positive and Negative Syndrome Scale (PANSS) Total Score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 190 participants
79.42  (19.64)
[1]
Measure Description: 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.
Positive and Negative Syndrome Scale (PANSS) - Positive Subscale Score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 190 participants
18.96  (6.19)
[1]
Measure Description: 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).
Positive and Negative Syndrome Scale (PANSS) - Negative Subscale Score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 190 participants
20.61  (5.97)
[1]
Measure Description: 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).
Positive and Negative Syndrome Scale (PANSS) - General Psychopathology Subscale Score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 190 participants
18.00  (5.56)
[1]
Measure Description: 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).
Personal and Social Performance Scale (PSP) Score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 190 participants
54.08  (14.84)
[1]
Measure 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).
Drug Attitude Inventory (DAI-10)   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 190 participants
3.01  (4.31)
[1]
Measure Description: 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.
Subjective Well-being Under Neuroleptic (SWN-20) Scale Score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 190 participants
73.64  (16.87)
[1]
Measure Description: 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.
Daytime Drowsiness   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 190 participants
45.65  (29.97)
[1]
Measure Description: 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.
Sleep Quality   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 190 participants
61.90  (27.73)
[1]
Measure Description: 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.
Symptom Checklist 90-R (SCL90-R)   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 190 participants
91.72  (65.10)
[1]
Measure Description: 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.
1.Primary Outcome
Title Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 48
Hide Description 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. Change from Baseline is calculated as value at Baseline minus value at Week 48. Data for three groups is presented here, based on participants' transition to Paliperidone ER from other oral antipsychotics.
Time Frame Baseline and Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat (ITT) population for efficacy included all the participants who received paliperidone extended-release (ER) at least once and who had at least 1 post baseline efficacy assessment.
Arm/Group Title Paliperidone ER: Lack of Efficacy Paliperidone ER: Lack of Tolerability Paliperidone ER: Lack of Compliance
Hide Arm/Group Description:
Paliperidone ER tablet in dose range of 3 to 12 milligram (mg) per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy (switching of antipsychotic drug was clinically necessary because of no or insufficient response to treatment despite antipsychotic drug therapy at an adequate dose).
Paliperidone ER tablet in dose range of 3 to 12 mg per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability (switching of antipsychotic drug was necessary due to lack of tolerability in the existing antipsychotic drug).
Paliperidone ER tablet in dose range of 3 to 12 mg per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of compliance (switching of antipsychotic drug was necessary due to lack of compliance in the existing antipsychotic drug).
Overall Number of Participants Analyzed 144 21 25
Mean (Standard Deviation)
Unit of Measure: Units on a scale
11.57  (16.95) 6.43  (13.94) 16.36  (17.44)
2.Primary Outcome
Title Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Positive Subscale Score at Week 48
Hide Description 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). Change from Baseline is calculated as value at Baseline minus value at Week 48. Data for three groups is presented here, based on participants' transition to Paliperidone ER from other oral antipsychotics.
Time Frame Baseline and Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population for efficacy included all the participants who received paliperidone ER at least once and who had at least 1 post baseline efficacy assessment.
Arm/Group Title Paliperidone ER: Lack of Efficacy Paliperidone ER: Lack of Tolerability Paliperidone ER: Lack of Compliance
Hide Arm/Group Description:
Paliperidone ER tablet in dose range of 3 to 12 milligram (mg) per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy (switching of antipsychotic drug was clinically necessary because of no or insufficient response to treatment despite antipsychotic drug therapy at an adequate dose).
Paliperidone ER tablet in dose range of 3 to 12 mg per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability (switching of antipsychotic drug was necessary due to lack of tolerability in the existing antipsychotic drug).
Paliperidone ER tablet in dose range of 3 to 12 mg per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of compliance (switching of antipsychotic drug was necessary due to lack of compliance in the existing antipsychotic drug).
Overall Number of Participants Analyzed 144 21 25
Mean (Standard Deviation)
Unit of Measure: Units on a scale
3.53  (5.23) 1.05  (2.75) 5.00  (6.40)
3.Primary Outcome
Title Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Negative Subscale Score at Week 48
Hide Description 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). Change from Baseline is calculated as value at Baseline minus value at Week 48. Data for three groups is presented here, based on participants' transition to Paliperidone ER from other oral antipsychotics.
Time Frame Baseline and Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population for efficacy included all the participants who received paliperidone ER at least once and who had at least 1 post baseline efficacy assessment.
Arm/Group Title Paliperidone ER: Lack of Efficacy Paliperidone ER: Lack of Tolerability Paliperidone ER: Lack of Compliance
Hide Arm/Group Description:
Paliperidone ER tablet in dose range of 3 to 12 milligram (mg) per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy (switching of antipsychotic drug was clinically necessary because of no or insufficient response to treatment despite antipsychotic drug therapy at an adequate dose).
Paliperidone ER tablet in dose range of 3 to 12 mg per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability (switching of antipsychotic drug was necessary due to lack of tolerability in the existing antipsychotic drug).
Paliperidone ER tablet in dose range of 3 to 12 mg per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of compliance (switching of antipsychotic drug was necessary due to lack of compliance in the existing antipsychotic drug).
Overall Number of Participants Analyzed 144 21 25
Mean (Standard Deviation)
Unit of Measure: Units on a scale
2.53  (4.60) 2.19  (4.07) 3.36  (5.51)
4.Primary Outcome
Title Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - General Psychopathology Subscale Score at Week 48
Hide Description 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). Change from Baseline is calculated as value at Baseline minus value at Week 48. Data for three groups is presented here, based on participants' transition to Paliperidone ER from other oral antipsychotics.
Time Frame Baseline and Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population for efficacy included all the participants who received paliperidone ER at least once and who had at least 1 post baseline efficacy assessment.
Arm/Group Title Paliperidone ER: Lack of Efficacy Paliperidone ER: Lack of Tolerability Paliperidone ER: Lack of Compliance
Hide Arm/Group Description:
Paliperidone ER tablet in dose range of 3 to 12 milligram (mg) per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy (switching of antipsychotic drug was clinically necessary because of no or insufficient response to treatment despite antipsychotic drug therapy at an adequate dose).
Paliperidone ER tablet in dose range of 3 to 12 mg per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability (switching of antipsychotic drug was necessary due to lack of tolerability in the existing antipsychotic drug).
Paliperidone ER tablet in dose range of 3 to 12 mg per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of compliance (switching of antipsychotic drug was necessary due to lack of compliance in the existing antipsychotic drug).
Overall Number of Participants Analyzed 144 21 25
Mean (Standard Deviation)
Unit of Measure: Units on a scale
5.51  (9.41) 3.19  (8.68) 8.00  (8.30)
5.Secondary Outcome
Title Change From Baseline in Personal and Social Performance Scale (PSP) Score at Week 48
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). Change from Baseline is calculated as value at Baseline minus value at Week 48. Data for three groups is presented here, based on participants' transition to Paliperidone ER from other oral antipsychotics.
Time Frame Baseline and Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population for efficacy included all the participants who received paliperidone ER at least once and who had at least 1 post baseline efficacy assessment.
Arm/Group Title Paliperidone ER: Lack of Efficacy Paliperidone ER: Lack of Tolerability Paliperidone ER: Lack of Compliance
Hide Arm/Group Description:
Paliperidone ER tablet in dose range of 3 to 12 milligram (mg) per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy (switching of antipsychotic drug was clinically necessary because of no or insufficient response to treatment despite antipsychotic drug therapy at an adequate dose).
Paliperidone ER tablet in dose range of 3 to 12 mg per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability (switching of antipsychotic drug was necessary due to lack of tolerability in the existing antipsychotic drug).
Paliperidone ER tablet in dose range of 3 to 12 mg per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of compliance (switching of antipsychotic drug was necessary due to lack of compliance in the existing antipsychotic drug).
Overall Number of Participants Analyzed 144 21 25
Mean (Standard Deviation)
Unit of Measure: Units on a scale
-6.73  (14.16) -2.38  (9.86) -11.36  (13.90)
6.Secondary Outcome
Title Change From Baseline in Drug Attitude Inventory (DAI-10) at Week 48
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. 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, higher score indicates positive SR (compliant) and lower score indicates negative SR (non-compliant). Change from Baseline is calculated as value at Baseline minus value at Week 48. Data for three groups is presented here, based on participants' transition to Paliperidone ER from other oral antipsychotics.
Time Frame Baseline and Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population for efficacy included all the participants who received paliperidone ER at least once and who had at least 1 post baseline efficacy assessment. "N" (number of participants analyzed) signifies the participants evaluable for this measure.
Arm/Group Title Paliperidone ER: Lack of Efficacy Paliperidone ER: Lack of Tolerability Paliperidone ER: Lack of Compliance
Hide Arm/Group Description:
Paliperidone ER tablet in dose range of 3 to 12 milligram (mg) per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy (switching of antipsychotic drug was clinically necessary because of no or insufficient response to treatment despite antipsychotic drug therapy at an adequate dose).
Paliperidone ER tablet in dose range of 3 to 12 mg per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability (switching of antipsychotic drug was necessary due to lack of tolerability in the existing antipsychotic drug).
Paliperidone ER tablet in dose range of 3 to 12 mg per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of compliance (switching of antipsychotic drug was necessary due to lack of compliance in the existing antipsychotic drug).
Overall Number of Participants Analyzed 140 21 24
Mean (Standard Deviation)
Unit of Measure: Units on a scale
-0.01  (4.72) -0.95  (4.27) 0.08  (4.19)
7.Secondary Outcome
Title Change From Baseline in Subjective Well-being Under Neuroleptic (SWN-20) Scale Score at Week 48
Hide Description 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. Change from Baseline is calculated as value at Baseline minus value at Week 48. Data for three groups is presented here, based on participants' transition to Paliperidone ER from other oral antipsychotics.
Time Frame Baseline and Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population for efficacy included all the participants who received paliperidone ER at least once and who had at least 1 post baseline efficacy assessment. 'N' (number of participants analyzed) signifies the participants evaluable for this measure.
Arm/Group Title Paliperidone ER: Lack of Efficacy Paliperidone ER: Lack of Tolerability Paliperidone ER: Lack of Compliance
Hide Arm/Group Description:
Paliperidone ER tablet in dose range of 3 to 12 milligram (mg) per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy (switching of antipsychotic drug was clinically necessary because of no or insufficient response to treatment despite antipsychotic drug therapy at an adequate dose).
Paliperidone ER tablet in dose range of 3 to 12 mg per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability (switching of antipsychotic drug was necessary due to lack of tolerability in the existing antipsychotic drug).
Paliperidone ER tablet in dose range of 3 to 12 mg per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of compliance (switching of antipsychotic drug was necessary due to lack of compliance in the existing antipsychotic drug).
Overall Number of Participants Analyzed 140 21 25
Mean (Standard Deviation)
Unit of Measure: Units on a scale
-1.17  (14.37) -5.05  (14.03) 2.40  (11.85)
8.Secondary Outcome
Title Change From Baseline in Daytime Drowsiness at Week 48
Hide Description 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. Change from Baseline is calculated as value at Baseline minus value at Week 48. Data for three groups is presented here, based on participants' transition to Paliperidone ER from other oral antipsychotics.
Time Frame Baseline and Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population for efficacy included all the participants who received paliperidone ER at least once and who had at least 1 post baseline efficacy assessment. 'N' (number of participants analyzed) signifies the participants evaluable for this measure.
Arm/Group Title Paliperidone ER: Lack of Efficacy Paliperidone ER: Lack of Tolerability Paliperidone ER: Lack of Compliance
Hide Arm/Group Description:
Paliperidone ER tablet in dose range of 3 to 12 milligram (mg) per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy (switching of antipsychotic drug was clinically necessary because of no or insufficient response to treatment despite antipsychotic drug therapy at an adequate dose).
Paliperidone ER tablet in dose range of 3 to 12 mg per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability (switching of antipsychotic drug was necessary due to lack of tolerability in the existing antipsychotic drug).
Paliperidone ER tablet in dose range of 3 to 12 mg per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of compliance (switching of antipsychotic drug was necessary due to lack of compliance in the existing antipsychotic drug).
Overall Number of Participants Analyzed 140 21 25
Mean (Standard Deviation)
Unit of Measure: millimeter (mm)
5.40  (34.11) 2.10  (27.76) 11.40  (24.61)
9.Secondary Outcome
Title Change From Baseline in Sleep Quality at Week 48
Hide Description 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. Change from Baseline is calculated as value at Baseline minus value at Week 48. Data for three groups is presented here, based on participants' transition to Paliperidone ER from other oral antipsychotics.
Time Frame Baseline and Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population for efficacy included all the participants who received paliperidone ER at least once and who had at least 1 post baseline efficacy assessment. 'N' (number of participants analyzed) signifies the participants evaluable for this measure.
Arm/Group Title Paliperidone ER: Lack of Efficacy Paliperidone ER: Lack of Tolerability Paliperidone ER: Lack of Compliance
Hide Arm/Group Description:
Paliperidone ER tablet in dose range of 3 to 12 milligram (mg) per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy (switching of antipsychotic drug was clinically necessary because of no or insufficient response to treatment despite antipsychotic drug therapy at an adequate dose).
Paliperidone ER tablet in dose range of 3 to 12 mg per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability (switching of antipsychotic drug was necessary due to lack of tolerability in the existing antipsychotic drug).
Paliperidone ER tablet in dose range of 3 to 12 mg per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of compliance (switching of antipsychotic drug was necessary due to lack of compliance in the existing antipsychotic drug).
Overall Number of Participants Analyzed 140 21 25
Mean (Standard Deviation)
Unit of Measure: millimeter (mm)
1.50  (32.94) -7.76  (31.20) 3.40  (35.34)
10.Secondary Outcome
Title Change From Baseline in Symptom Checklist 90-R (SCL90-R) at Week 48
Hide Description 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. Total scale score range from 0 to 360. Higher scores indicate worsening of disease. Change from Baseline is calculated as value at Baseline minus value at Week 48. Data for three groups is presented here, based on participants' transition to Paliperidone ER from other oral antipsychotics.
Time Frame Baseline and Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population for efficacy included all the participants who received paliperidone ER at least once and who had at least 1 post baseline efficacy assessment. 'N' (number of participants analyzed) signifies the participants evaluable for this measure.
Arm/Group Title Paliperidone ER: Lack of Efficacy Paliperidone ER: Lack of Tolerability Paliperidone ER: Lack of Compliance
Hide Arm/Group Description:
Paliperidone ER tablet in dose range of 3 to 12 milligram (mg) per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy (switching of antipsychotic drug was clinically necessary because of no or insufficient response to treatment despite antipsychotic drug therapy at an adequate dose).
Paliperidone ER tablet in dose range of 3 to 12 mg per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability (switching of antipsychotic drug was necessary due to lack of tolerability in the existing antipsychotic drug).
Paliperidone ER tablet in dose range of 3 to 12 mg per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of compliance (switching of antipsychotic drug was necessary due to lack of compliance in the existing antipsychotic drug).
Overall Number of Participants Analyzed 140 21 25
Mean (Standard Deviation)
Unit of Measure: Units on a scale
14.88  (48.32) 12.38  (32.01) 25.44  (44.41)
Time Frame Baseline up to Week 48
Adverse Event Reporting Description Safety population included all the eligible participants who received paliperidone extended-release (ER) at least once .
 
Arm/Group Title Paliperidone
Hide Arm/Group Description 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.
All-Cause Mortality
Paliperidone
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Paliperidone
Affected / at Risk (%)
Total   23/190 (12.11%) 
Gastrointestinal disorders   
Inguinal Hernia * 1  1/190 (0.53%) 
General disorders   
Asthenia * 1  1/190 (0.53%) 
Pyrexia * 1  1/190 (0.53%) 
Injury, poisoning and procedural complications   
Fall * 1  1/190 (0.53%) 
Lumbar Vertebral Fracture * 1  1/190 (0.53%) 
Overdose * 1  1/190 (0.53%) 
Subdural Haemorrhage * 1  1/190 (0.53%) 
Musculoskeletal and connective tissue disorders   
Neck Pain * 1  1/190 (0.53%) 
Nervous system disorders   
Syncope * 1  1/190 (0.53%) 
Psychiatric disorders   
Agitated Depression * 1  1/190 (0.53%) 
Alcoholism * 1  1/190 (0.53%) 
Anxiety * 1  1/190 (0.53%) 
Completed Suicide * 1  2/190 (1.05%) 
Confusional State * 1  1/190 (0.53%) 
Depressive Symptom * 1  2/190 (1.05%) 
Hallucination, Auditory * 1  1/190 (0.53%) 
Persecutory Delusion * 1  1/190 (0.53%) 
Schizophrenia * 1  6/190 (3.16%) 
Suicidal Behaviour * 1  1/190 (0.53%) 
Suicide Attempt * 1  2/190 (1.05%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
Paliperidone
Affected / at Risk (%)
Total   109/190 (57.37%) 
Endocrine disorders   
Hyperprolactinaemia * 1  11/190 (5.79%) 
Eye disorders   
Vision Blurred * 1  4/190 (2.11%) 
Gastrointestinal disorders   
Constipation * 1  6/190 (3.16%) 
Dry Mouth * 1  7/190 (3.68%) 
Dyspepsia * 1  4/190 (2.11%) 
Vomiting * 1  4/190 (2.11%) 
General disorders   
Fatigue * 1  7/190 (3.68%) 
Gait Disturbance * 1  5/190 (2.63%) 
Investigations   
Weight Decreased * 1  5/190 (2.63%) 
Weight Increased * 1  29/190 (15.26%) 
Musculoskeletal and connective tissue disorders   
Muscle Rigidity * 1  14/190 (7.37%) 
Nervous system disorders   
Akathisia * 1  35/190 (18.42%) 
Bradykinesia * 1  11/190 (5.79%) 
Dizziness * 1  8/190 (4.21%) 
Dysarthria * 1  5/190 (2.63%) 
Dyskinesia * 1  5/190 (2.63%) 
Dystonia * 1  6/190 (3.16%) 
Headache * 1  5/190 (2.63%) 
Paraesthesia * 1  4/190 (2.11%) 
Sedation * 1  6/190 (3.16%) 
Somnolence * 1  7/190 (3.68%) 
Tremor * 1  14/190 (7.37%) 
Psychiatric disorders   
Anxiety * 1  4/190 (2.11%) 
Insomnia * 1  13/190 (6.84%) 
Reproductive system and breast disorders   
Amenorrhoea * 1  7/190 (3.68%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA
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
Layout table for Results Point of Contact information
Name/Title: Senior Clinical Research Associate
Organization: Clinical Research Team, Medical Affairs Korea
Phone: 82-2094-4804
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Responsible Party: Janssen Korea, Ltd., Korea
ClinicalTrials.gov Identifier: NCT00761579     History of Changes
Other Study ID Numbers: CR015250
PAL-KOR-4002
First Submitted: September 25, 2008
First Posted: September 29, 2008
Results First Submitted: January 16, 2014
Results First Posted: June 3, 2014
Last Update Posted: June 3, 2014