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Efficacy Study of Paliperidone to Evaluate Subjective Change in Well-being and Drug Attitude in Schizophrenic Participants (Power)

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ClinicalTrials.gov Identifier: NCT00784238
Recruitment Status : Completed
First Posted : November 3, 2008
Results First Posted : March 27, 2014
Last Update Posted : March 27, 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 289
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Paliperidone
Hide Arm/Group Description Paliperidone Extended-Release (ER) oral tablet was administered once daily at a starting dose of 6 milligram (mg) for 24 weeks, wherein dose range was 3 to 12 mg per day.
Period Title: Overall Study
Started 289
Completed 170
Not Completed 119
Reason Not Completed
Adverse Event             14
Death             2
Lack of Efficacy             33
Lost to Follow-up             29
Pregnancy             1
Withdrawal by Subject             26
Other             14
Arm/Group Title Paliperidone
Hide Arm/Group Description Paliperidone Extended-Release (ER) oral tablet was administered once daily at a starting dose of 6 milligram (mg) for 24 weeks, wherein dose range was 3 to 12 mg per day.
Overall Number of Baseline Participants 289
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 289 participants
36.4  (10.09)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 289 participants
Female
153
  52.9%
Male
136
  47.1%
1.Primary Outcome
Title Subjective Well-being Under Neuroleptic (SWN-20) Scale Total Score at Week 24
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.
Time Frame Week 24
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
Hide Arm/Group Description:
Paliperidone Extended-Release (ER) oral tablet was administered once daily at a starting dose of 6 milligram (mg) for 24 weeks, wherein dose range was 3 to 12 mg per day.
Overall Number of Participants Analyzed 284
Mean (Standard Deviation)
Unit of Measure: Units on a scale
77.89  (17.95)
2.Primary Outcome
Title Change From Baseline in Subjective Well-being Under Neuroleptic (SWN-20) Scale at Week 24
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 was calculated as value at Baseline minus value at Week 24. Data for three groups is presented here, based on participants' transition to Paliperidone ER from other oral antipsychotics.
Time Frame Baseline and Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
The 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 (Lack of Efficacy Group) Paliperidone (Lack of Tolerability Group) Paliperidone (Lack of Compliance Group)
Hide Arm/Group Description:
Paliperidone ER tablet at a dose ranging from 3 to 12 milligram (mg) per day was given orally for 24 weeks 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 at a dose ranging from 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 or safety problem in the existing antipsychotic drug).
Paliperidone ER tablet at a dose ranging from 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 179 47 58
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Baseline 74.59  (17.81) 76.51  (17.61) 81.19  (15.68)
Change at Week 24 -1.59  (13.75) -2.66  (13.72) -0.93  (16.93)
3.Primary Outcome
Title Change From Baseline in Mental Functioning Subscale Score Based on Subjective Well-being Under Neuroleptic (SWN-20) Scale at Week 24
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. Mental functioning subscale score ranges from 0 to 24 and higher score indicates improvement of disease. Change from Baseline was calculated as value at Baseline minus value at Week 24. Data for three groups is presented here, based on participants' transition to Paliperidone ER from other oral antipsychotics.
Time Frame Baseline and Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
The 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 (Lack of Efficacy Group) Paliperidone (Lack of Tolerability Group) Paliperidone (Lack of Compliance Group)
Hide Arm/Group Description:
Paliperidone ER tablet at a dose ranging from 3 to 12 milligram (mg) per day was given orally for 24 weeks 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 at a dose ranging from 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 or safety problem in the existing antipsychotic drug).
Paliperidone ER tablet at a dose ranging from 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 179 47 58
Mean (Standard Deviation)
Unit of Measure: Units on a scale
-0.14  (3.56) -0.51  (3.62) -0.24  (4.79)
4.Primary Outcome
Title Change From Baseline in Self-Control Subscale Score Based on Subjective Well-being Under Neuroleptic (SWN-20) Scale at Week 24
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. Self-Control subscale score ranges from 0 to 24 and higher score indicates improvement of disease. Change from Baseline was calculated as value at Baseline minus value at Week 24. Data for three groups is presented here, based on participants' transition to Paliperidone ER from other oral antipsychotics.
Time Frame Baseline and Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
The 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 (Lack of Efficacy Group) Paliperidone (Lack of Tolerability Group) Paliperidone (Lack of Compliance Group)
Hide Arm/Group Description:
Paliperidone ER tablet at a dose ranging from 3 to 12 milligram (mg) per day was given orally for 24 weeks 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 at a dose ranging from 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 or safety problem in the existing antipsychotic drug).
Paliperidone ER tablet at a dose ranging from 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 179 47 58
Mean (Standard Deviation)
Unit of Measure: Units on a scale
-0.72  (3.74) -0.62  (4.05) -0.29  (4.07)
5.Primary Outcome
Title Change From Baseline in Emotional Regulation Subscale Score Based on Subjective Well-being Under Neuroleptic (SWN-20) Scale at Week 24
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. Emotional Regulation subscale score ranges from 0 to 24 and higher score indicates improvement of disease. Change from Baseline was calculated as value at Baseline minus value at Week 24. Data for three groups is presented here, based on participants' transition to Paliperidone ER from other oral antipsychotics.
Time Frame Baseline and Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
The 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 (Lack of Efficacy Group) Paliperidone (Lack of Tolerability Group) Paliperidone (Lack of Compliance Group)
Hide Arm/Group Description:
Paliperidone ER tablet at a dose ranging from 3 to 12 milligram (mg) per day was given orally for 24 weeks 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 at a dose ranging from 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 or safety problem in the existing antipsychotic drug).
Paliperidone ER tablet at a dose ranging from 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 179 47 58
Mean (Standard Deviation)
Unit of Measure: Units on a scale
-0.07  (3.61) 0.11  (4.07) 0.45  (3.97)
6.Primary Outcome
Title Change From Baseline in Physical Functioning Subscale Score Based on Subjective Well-being Under Neuroleptic (SWN-20) Scale at Week 24
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. Physical Functioning subscale score ranges from 0 to 24 and higher score indicates improvement of disease. Change from Baseline was calculated as value at Baseline minus value at Week 24. Data for three groups is presented here, based on participants' transition to Paliperidone ER from other oral antipsychotics.
Time Frame Baseline and Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
The 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 (Lack of Efficacy Group) Paliperidone (Lack of Tolerability Group) Paliperidone (Lack of Compliance Group)
Hide Arm/Group Description:
Paliperidone ER tablet at a dose ranging from 3 to 12 milligram (mg) per day was given orally for 24 weeks 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 at a dose ranging from 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 or safety problem in the existing antipsychotic drug).
Paliperidone ER tablet at a dose ranging from 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 179 47 58
Mean (Standard Deviation)
Unit of Measure: Units on a scale
-0.11  (4.15) -0.68  (4.25) 0.47  (4.50)
7.Primary Outcome
Title Change From Baseline in Social Integration Subscale Score Based on Subjective Well-being Under Neuroleptic (SWN-20) Scale at Week 24
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. Social integration subscale score ranges from 0 to 24 and higher score indicates improvement of disease. Change from Baseline was calculated as value at Baseline minus value at Week 24. Data for three groups is presented here, based on participants' transition to Paliperidone ER from other oral antipsychotics.
Time Frame Baseline and Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
The 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 (Lack of Efficacy Group) Paliperidone (Lack of Tolerability Group) Paliperidone (Lack of Compliance Group)
Hide Arm/Group Description:
Paliperidone ER tablet at a dose ranging from 3 to 12 milligram (mg) per day was given orally for 24 weeks 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 at a dose ranging from 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 or safety problem in the existing antipsychotic drug).
Paliperidone ER tablet at a dose ranging from 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 179 47 58
Mean (Standard Deviation)
Unit of Measure: Units on a scale
-0.55  (3.33) -0.96  (3.26) -1.31  (4.04)
8.Primary Outcome
Title Drug Attitude Inventory (DAI-10) Total Score at Week 24
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).
Time Frame Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
The 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
Hide Arm/Group Description:
Paliperidone Extended-Release (ER) oral tablet was administered once daily at a starting dose of 6 milligram (mg) for 24 weeks, wherein dose range was 3 to 12 mg per day.
Overall Number of Participants Analyzed 284
Mean (Standard Deviation)
Unit of Measure: Units on a scale
3.58  (4.73)
9.Primary Outcome
Title Change From Baseline in Drug Attitude Inventory (DAI-10) at Week 24
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 was calculated as value at Baseline minus value at Week 24. Data for three groups is presented here, based on participants' transition to Paliperidone ER from other oral antipsychotics.
Time Frame Baseline and Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
The 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 (Lack of Efficacy Group) Paliperidone (Lack of Tolerability Group) Paliperidone (Lack of Compliance Group)
Hide Arm/Group Description:
Paliperidone ER tablet at a dose ranging from 3 to 12 milligram (mg) per day was given orally for 24 weeks 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 at a dose ranging from 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 or safety problem in the existing antipsychotic drug).
Paliperidone ER tablet at a dose ranging from 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 179 47 58
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Baseline 3.12  (4.65) 3.49  (4.67) 2.50  (4.88)
Change at Week 24 -0.46  (4.70) -0.21  (4.92) -1.00  (5.03)
10.Secondary Outcome
Title Change From Baseline in Symptom Checklist 90-R (SCL90-R) at Week 24
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. Change from Baseline was calculated as value at Baseline minus value at Week 24. Data for three groups is presented here, based on participants' transition to Paliperidone ER from other oral antipsychotics.
Time Frame Baseline and Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
The 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 (Lack of Efficacy Group) Paliperidone (Lack of Tolerability Group) Paliperidone (Lack of Compliance Group)
Hide Arm/Group Description:
Paliperidone ER tablet at a dose ranging from 3 to 12 milligram (mg) per day was given orally for 24 weeks 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 at a dose ranging from 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 or safety problem in the existing antipsychotic drug).
Paliperidone ER tablet at a dose ranging from 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 179 47 57
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Baseline 109.65  (67.00) 107.23  (72.17) 83.39  (60.41)
Change at Week 24 2.42  (30.44) 9.40  (32.31) 1.16  (17.83)
11.Secondary Outcome
Title Change From Baseline in Krawiecka Scale Score at Week 24
Hide Description Psychopathology of participants was assessed by Krawiecka scale. Psychopathology of participants was assessed by Krawiecka scale, score ranges from 0 to 16. Higher score indicates worsening of disease. Change from Baseline was calculated as value at Baseline minus value at Week 24. Data for three groups is presented here, based on participants' transition to Paliperidone ER from other oral antipsychotics.
Time Frame Baseline and Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
The 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 (Lack of Efficacy Group) Paliperidone (Lack of Tolerability Group) Paliperidone (Lack of Compliance Group)
Hide Arm/Group Description:
Paliperidone ER tablet at a dose ranging from 3 to 12 milligram (mg) per day was given orally for 24 weeks 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 at a dose ranging from 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 or safety problem in the existing antipsychotic drug).
Paliperidone ER tablet at a dose ranging from 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 179 47 58
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Baseline 4.78  (3.12) 3.45  (2.82) 3.86  (2.96)
Change at Week 24 0.94  (2.90) 1.09  (2.80) 1.09  (3.00)
12.Secondary Outcome
Title Change From Baseline in Total Personal and Social Performance (PSP) Score at Week 24
Hide Description The PSP scale assesses the degree of 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 (1, absent to 6, very severe) in each of the 4 domains. Participants with a score of 71 to 100 have a mild degree of difficulty; from 31 to 70, varying degrees of disability; less or equal to 30, functioning so poorly as to require intensive supervision. Change from Baseline was calculated as value at Baseline minus value at Week 24. Data for three groups is presented here, based on participants' transition to Paliperidone ER from other oral antipsychotics.
Time Frame Baseline and Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
The 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 (Lack of Efficacy Group) Paliperidone (Lack of Tolerability Group) Paliperidone (Lack of Compliance Group)
Hide Arm/Group Description:
Paliperidone ER tablet at a dose ranging from 3 to 12 milligram (mg) per day was given orally for 24 weeks 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 at a dose ranging from 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 or safety problem in the existing antipsychotic drug).
Paliperidone ER tablet at a dose ranging from 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 179 47 58
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Baseline 52.15  (15.44) 57.91  (16.31) 58.71  (12.62)
Change at Week 24 -6.50  (14.36) -7.23  (12.49) -6.28  (10.70)
13.Secondary Outcome
Title Change From Baseline in Sleep Quality Based on Visual Analog Scale at Week 24
Hide Description Sleep quality was assessed by an 11-point visual analog scale that rates how well participants slept. Participants indicated on the scale (from 0 to 100 millimeter) how well they slept in the previous 7 days (from 0: "very badly" to 100: "very well"). Change from Baseline was calculated as value at Baseline minus value at Week 24. Data for three groups is presented here, based on participants' transition to Paliperidone ER from other oral antipsychotics.
Time Frame Baseline and Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
The 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 (Lack of Efficacy Group) Paliperidone (Lack of Tolerability Group) Paliperidone (Lack of Compliance Group)
Hide Arm/Group Description:
Paliperidone ER tablet at a dose ranging from 3 to 12 milligram (mg) per day was given orally for 24 weeks 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 at a dose ranging from 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 or safety problem in the existing antipsychotic drug).
Paliperidone ER tablet at a dose ranging from 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 179 47 58
Mean (Standard Deviation)
Unit of Measure: Millimeter (mm)
Baseline 61.84  (29.34) 71.55  (24.92) 69.31  (23.48)
Change at Week 24 -0.84  (31.22) -0.43  (30.25) -0.67  (22.42)
14.Secondary Outcome
Title Change From Baseline in Daytime Drowsiness Based on Visual Analog Scale at Week 24
Hide Description Daytime drowsiness was assessed by an 11-point visual analog scale that rates how well participants slept. Participants indicated on the scale (from 0 to 100 millimeter) how often they felt drowsy in the previous 7 days (from 0: "very badly" to 100: "very well"). Change from Baseline was calculated as value at Baseline minus value at Week 24. Data for three groups is presented here, based on participants' transition to Paliperidone ER from other oral antipsychotics.
Time Frame Baseline and Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
The 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 (Lack of Efficacy Group) Paliperidone (Lack of Tolerability Group) Paliperidone (Lack of Compliance Group)
Hide Arm/Group Description:
Paliperidone ER tablet at a dose ranging from 3 to 12 milligram (mg) per day was given orally for 24 weeks 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 at a dose ranging from 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 or safety problem in the existing antipsychotic drug).
Paliperidone ER tablet at a dose ranging from 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 179 47 58
Mean (Standard Deviation)
Unit of Measure: Millimeter (mm)
Baseline 40.57  (31.79) 45.96  (31.18) 46.55  (28.65)
Change at Week 24 -1.18  (32.17) 3.94  (28.02) 10.05  (25.75)
Time Frame Baseline up to Week 96
Adverse Event Reporting Description Safety population included all the participants who received paliperidone extended-release (ER) at least once.
 
Arm/Group Title Paliperidone
Hide Arm/Group Description Paliperidone Extended-Release (ER) oral tablet was administered once daily at a starting dose of 6 milligram (mg) for 24 weeks, wherein 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   21/289 (7.27%) 
General disorders   
Condition Aggravated * 1  1/289 (0.35%) 
Injury, poisoning and procedural complications   
Ankle Fracture * 1  1/289 (0.35%) 
Road Traffic Accident * 1  1/289 (0.35%) 
Investigations   
Hepatic Enzyme Increased * 1  1/289 (0.35%) 
Musculoskeletal and connective tissue disorders   
Muscle Rigidity * 1  1/289 (0.35%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Uterine Leiomyoma * 1  1/289 (0.35%) 
Nervous system disorders   
Dizziness * 1  1/289 (0.35%) 
Dystonia * 1  1/289 (0.35%) 
Pregnancy, puerperium and perinatal conditions   
Ectopic Pregnancy * 1  1/289 (0.35%) 
Psychiatric disorders   
Acute Psychosis * 1  1/289 (0.35%) 
Completed Suicide * 1  2/289 (0.69%) 
Delusion * 1  1/289 (0.35%) 
Hallucination, Auditory * 1  3/289 (1.04%) 
Insomnia * 1  1/289 (0.35%) 
Psychotic Behaviour * 1  2/289 (0.69%) 
Psychotic Disorder * 1  1/289 (0.35%) 
Schizophrenia * 1  4/289 (1.38%) 
Schizophrenia, Paranoid Type * 1  1/289 (0.35%) 
Social Avoidant Behaviour * 1  1/289 (0.35%) 
Suicidal Ideation * 1  1/289 (0.35%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 16.0
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   112/289 (38.75%) 
Gastrointestinal disorders   
Constipation * 1  11/289 (3.81%) 
Dry Mouth * 1  8/289 (2.77%) 
Dyspepsia * 1  7/289 (2.42%) 
Nausea * 1  8/289 (2.77%) 
Investigations   
Weight Increased * 1  6/289 (2.08%) 
Musculoskeletal and connective tissue disorders   
Muscle Rigidity * 1  7/289 (2.42%) 
Nervous system disorders   
Akathisia * 1  24/289 (8.30%) 
Bradykinesia * 1  12/289 (4.15%) 
Dizziness * 1  11/289 (3.81%) 
Dystonia * 1  9/289 (3.11%) 
Essential Tremor * 1  6/289 (2.08%) 
Extrapyramidal Disorder * 1  14/289 (4.84%) 
Headache * 1  10/289 (3.46%) 
Sedation * 1  6/289 (2.08%) 
Somnolence * 1  7/289 (2.42%) 
Tremor * 1  14/289 (4.84%) 
Psychiatric disorders   
Insomnia * 1  14/289 (4.84%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 16.0
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: Senior Clinical research Associate
Organization: Clinical Research Team, Medical Affairs Korea
Phone: 82-2-2094-4804
Responsible Party: Janssen Korea, Ltd., Korea
ClinicalTrials.gov Identifier: NCT00784238     History of Changes
Other Study ID Numbers: CR015391
R076477SCH4028
First Submitted: October 31, 2008
First Posted: November 3, 2008
Results First Submitted: February 7, 2014
Results First Posted: March 27, 2014
Last Update Posted: March 27, 2014