PASS: Phase 4 Study to Evaluate Efficacy of Paliperidone Extended-Release(ER) in Schizophrenic Participants
Study Details
Study Description
Brief Summary
The purpose of this study is to investigate the efficacy of flexibly dosed paliperidone extended-release (mechanism to dissolve a drug over time in order to be released slower and steadier into the blood stream) in improving or maintaining the subjective symptoms of the participants in three participants' groups (that is, by the reason to switch: lack of efficacy group, lack of tolerability group, and lack of compliance group) who switched from other previous antipsychotic drugs to paliperidone extended-release tablets at flexible doses.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 4 |
Detailed Description
This is an open-label (all people know the identity of the intervention), prospective (study following participants forward in time), single arm, and non-comparative study of paliperidone Extended-release (ER) in participants switching from the previous oral antipsychotic to flexibly dosed paliperidone ER. The total study duration will be approximately of 24 weeks per participant. The study consists of 2 parts: Screening (that is, 14 days before study commences on Day 1); Treatment (24 weeks). Efficacy will primarily be evaluated by change from baseline in symptom checklist 90-R (SCL90-R) at Week 24. Participants' safety will be monitored throughout the study.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Paliperidone Paliperidone oral tablet will be administered once daily at a dose of 6 milligram (mg) for 24 weeks, wherein dose range was 3 to 12 mg per day. |
Drug: Paliperidone
Paliperidone oral tablet will be administered once daily at a dose of 6 milligram (mg) for 24 weeks, wherein dose range was 3 to 12 mg per day.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Change From Baseline in Symptom Checklist 90-R (SCL90-R) at Week 24 [Baseline and Week 24]
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.
Secondary Outcome Measures
- Change From Baseline in Total Personal and Social Performance (PSP) Score at Week 24 [Baseline and Week 24]
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.
- Change From Baseline in Subjective Well-being Under Neuroleptic (SWN-20) Scale at Week 24 [Baseline and Week 24]
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.
- Change From Baseline in Sleep Quality Based on Visual Analog Scale at Week 24 [Baseline and Week 24]
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 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.
- Change From Baseline in Daytime Drowsiness Based on Visual Analog Scale at Week 24 [Baseline and Week 24]
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 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.
- Change From Baseline in Krawiecka Scale Score at Week 24 [Baseline and Week 24]
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.
- Change From Baseline in Clinical Global Impression - Severity (CGI-S) Score at Week 24 [Baseline and Week 24]
The CGI-S rating scale is a 7 point global assessment that measures the clinician's impression of the severity of illness exhibited by a participant. A rating of 1 is equivalent to "Normal, not at all ill" and a rating of 7 is equivalent to "Among the most extremely ill participants". Higher scores indicate worsening. 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.
- Change From Baseline in Clinical Global Impression - Improvement (CGI-I) Score at Week 24 [Baseline and Week 24]
The CGI-I is a 7-point scale that requires the clinician to assess how much the participant's illness has improved or worsened relative to a baseline state at the beginning of the intervention and rated as: 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse. 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.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Childbearing potential women who consent to the use of the consistently permissible contraception (oral contraceptive, contraceptive injection, intrauterine device, double barrier method and contraceptive patch)
-
Participants who are compliant with self-medication or can receive consistent help or support
-
Participants who need to change the antipsychotic drug to another one for the following reasons among the participants treated with an antipsychotic drug for more than two weeks before the screening (1) Group of lack of efficacy: The antipsychotic drug is clinically required to be changed because there is no or little therapeutic response despite the appropriately dosed antipsychotic therapy (2) Group of lack of tolerance: The antipsychotic drug is required to be changed due to lack of tolerance to the existing antipsychotic drug or the safety issue (3) Group of lack of compliance: The antipsychotic drug is required to be changed due to lack of medication compliance or the participant wants to change the antipsychotic drug)
Exclusion Criteria:
-
Participants with the past history of neuroleptic malignant syndrome (NMS)
-
Participants who are suspicious of having clinically significant risk including suicide or aggressive behavior and are expected to unable to complete the study (based on the investigator's judgment)
-
Participants with severe preexisting gastrointestinal narrowing (pathologic or iatrogenic) or participants who cannot swallow the drug whole (The study drug must not be chewed, divided, melted or grinded because it can impact the study drug release profile
-
Female participants who are pregnant or are breast feeding
-
Participants who have participated in any investigational drug trial within 1 month prior to the screening visit
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Chunchun | Korea, Republic of | |||
| 2 | Incheon | Korea, Republic of | |||
| 3 | Inchun | Korea, Republic of | |||
| 4 | Kangwondo | Korea, Republic of | |||
| 5 | Kyunggido | Korea, Republic of | |||
| 6 | Kyungki | Korea, Republic of | |||
| 7 | Kyunki | Korea, Republic of | |||
| 8 | Seoul | Korea, Republic of |
Sponsors and Collaborators
- Janssen Korea, Ltd., Korea
Investigators
- Study Director: Janssen Korea, Ltd., Korea Clinical Trial, Janssen Korea, Ltd., Korea
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CR015253
- PAL-KOR-4003
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Paliperidone |
|---|---|
| Arm/Group Description | Paliperidone oral tablet was administered once daily at a dose of 6 milligram (mg) for 24 weeks, wherein dose range was 3 to 12 mg per day. |
| Period Title: Overall Study | |
| STARTED | 387 |
| COMPLETED | 246 |
| NOT COMPLETED | 141 |
Baseline Characteristics
| Arm/Group Title | Paliperidone |
|---|---|
| Arm/Group Description | Paliperidone oral tablet was administered once daily at a dose of 6 milligram (mg) for 24 weeks, wherein dose range was 3 to 12 mg per day. |
| Overall Participants | 387 |
| Age (years) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [years] |
36.73
(10.97)
|
| Sex: Female, Male (Count of Participants) | |
| Female |
214
55.3%
|
| Male |
173
44.7%
|
Outcome Measures
| Title | Change From Baseline in Symptom Checklist 90-R (SCL90-R) at Week 24 |
|---|---|
| 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 |
Outcome Measure Data
| 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. "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) |
|---|---|---|---|
| Arm/Group Description | Paliperidone Extended-release (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). |
| Measure Participants | 277 | 78 | 32 |
| Baseline |
99.84
(70.35)
|
73.03
(57.60)
|
67.66
(58.86)
|
| Change at Week 24 |
13.09
(57.78)
|
8.87
(33.17)
|
10.50
(42.33)
|
| Title | Change From Baseline in Total Personal and Social Performance (PSP) Score at Week 24 |
|---|---|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The 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 (Lack of Efficacy Group) | Paliperidone (Lack of Tolerability Group) | Paliperidone (Lack of Compliance Group) |
|---|---|---|---|
| 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 tolerability or safety problem in the existing antipsychotic drug). |
| Measure Participants | 277 | 78 | 32 |
| Baseline |
56.03
(15.51)
|
63.62
(11.76)
|
63.44
(16.07)
|
| Change at Week 24 |
-5.81
(11.73)
|
-3.77
(8.12)
|
-4.59
(11.32)
|
| Title | Change From Baseline in Subjective Well-being Under Neuroleptic (SWN-20) Scale at Week 24 |
|---|---|
| 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 |
Outcome Measure Data
| 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 participants evaluable for this measure. |
| Arm/Group Title | Paliperidone (Lack of Efficacy Group) | Paliperidone (Lack of Tolerability Group) | Paliperidone (Lack of Compliance Group) |
|---|---|---|---|
| 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 tolerability or safety problem in the existing antipsychotic drug). |
| Measure Participants | 276 | 78 | 32 |
| Baseline |
70.61
(17.09)
|
76.67
(18.40)
|
80.50
(17.01)
|
| Change at Week 24 |
-1.54
(14.62)
|
-2.33
(15.11)
|
-1.06
(13.87)
|
| Title | Change From Baseline in Sleep Quality Based on Visual Analog Scale at Week 24 |
|---|---|
| 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 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 |
Outcome Measure Data
| 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 participants evaluable for this measure. |
| Arm/Group Title | Paliperidone (Lack of Efficacy Group) | Paliperidone (Lack of Tolerability Group) | Paliperidone (Lack of Compliance Group) |
|---|---|---|---|
| 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 tolerability or safety problem in the existing antipsychotic drug). |
| Measure Participants | 277 | 77 | 32 |
| Baseline |
65.62
(30.52)
|
70.89
(24.90)
|
62.45
(30.96)
|
| Change at Week 24 |
1.74
(36.00)
|
3.66
(27.79)
|
-1.94
(34.18)
|
| Title | Change From Baseline in Daytime Drowsiness Based on Visual Analog Scale at Week 24 |
|---|---|
| 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 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 |
Outcome Measure Data
| 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 participants evaluable for this measure. |
| Arm/Group Title | Paliperidone (Lack of Efficacy Group) | Paliperidone (Lack of Tolerability Group) | Paliperidone (Lack of Compliance Group) |
|---|---|---|---|
| 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 tolerability or safety problem in the existing antipsychotic drug). |
| Measure Participants | 277 | 77 | 32 |
| Baseline |
43.27
(31.65)
|
39.40
(28.02)
|
44.47
(28.12)
|
| Change at Week 24 |
4.80
(33.31)
|
2.42
(30.84)
|
7.83
(36.24)
|
| Title | Change From Baseline in Krawiecka Scale Score at Week 24 |
|---|---|
| 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 |
Outcome Measure Data
| 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 (Lack of Efficacy Group) | Paliperidone (Lack of Tolerability Group) | Paliperidone (Lack of Compliance Group) |
|---|---|---|---|
| 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 tolerability or safety problem in the existing antipsychotic drug). |
| Measure Participants | 277 | 78 | 32 |
| Baseline |
5.38
(3.28)
|
4.74
(2.99)
|
4.38
(3.02)
|
| Change at Week 24 |
1.43
(2.62)
|
1.32
(1.94)
|
1.69
(2.72)
|
| Title | Change From Baseline in Clinical Global Impression - Severity (CGI-S) Score at Week 24 |
|---|---|
| Description | The CGI-S rating scale is a 7 point global assessment that measures the clinician's impression of the severity of illness exhibited by a participant. A rating of 1 is equivalent to "Normal, not at all ill" and a rating of 7 is equivalent to "Among the most extremely ill participants". Higher scores indicate worsening. 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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 (Lack of Efficacy Group) | Paliperidone (Lack of Tolerability Group) | Paliperidone (Lack of Compliance Group) |
|---|---|---|---|
| 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 tolerability or safety problem in the existing antipsychotic drug). |
| Measure Participants | 277 | 78 | 32 |
| Baseline |
3.77
(1.16)
|
3.46
(0.98)
|
3.25
(1.05)
|
| Change at Week 24 |
0.70
(1.04)
|
0.47
(0.86)
|
0.47
(0.95)
|
| Title | Change From Baseline in Clinical Global Impression - Improvement (CGI-I) Score at Week 24 |
|---|---|
| Description | The CGI-I is a 7-point scale that requires the clinician to assess how much the participant's illness has improved or worsened relative to a baseline state at the beginning of the intervention and rated as: 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse. 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The 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. "N" (number of participants analyzed) signifies participants evaluable for this measure. |
| Arm/Group Title | Paliperidone (Lack of Efficacy Group) | Paliperidone (Lack of Tolerability Group) | Paliperidone (Lack of Compliance Group) |
|---|---|---|---|
| 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 tolerability or safety problem in the existing antipsychotic drug). |
| Measure Participants | 268 | 76 | 31 |
| Baseline |
3.63
(0.91)
|
3.66
(0.60)
|
3.48
(1.00)
|
| Change at Week 24 |
0.46
(1.23)
|
0.37
(0.96)
|
0.35
(1.17)
|
Adverse Events
| Time Frame | Baseline up to Week 24 | |
|---|---|---|
| Adverse Event Reporting Description | Safety population included all the eligible participants who received paliperidone extended-release (ER) at least once . | |
| Arm/Group Title | Paliperidone | |
| Arm/Group Description | Paliperidone oral tablet was administered once daily at a 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 (%) | # Events | |
| Total | / (NaN) | |
Serious Adverse Events |
||
| Paliperidone | ||
| Affected / at Risk (%) | # Events | |
| Total | 38/387 (9.8%) | |
| Cardiac disorders | ||
| Acute myocardial infarction | 1/387 (0.3%) | |
| Endocrine disorders | ||
| Hyperprolactinaemia | 1/387 (0.3%) | |
| Injury, poisoning and procedural complications | ||
| Overdose | 1/387 (0.3%) | |
| Musculoskeletal and connective tissue disorders | ||
| Intervertebral disc degeneration | 1/387 (0.3%) | |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||
| Colon cancer stage IV | 1/387 (0.3%) | |
| Metastases to liver | 1/387 (0.3%) | |
| Nervous system disorders | ||
| Headache | 1/387 (0.3%) | |
| Syncope | 1/387 (0.3%) | |
| Psychiatric disorders | ||
| Acute psychosis | 1/387 (0.3%) | |
| Aggression | 1/387 (0.3%) | |
| Anxiety | 1/387 (0.3%) | |
| Completed suicide | 5/387 (1.3%) | |
| Delusion | 3/387 (0.8%) | |
| Hallucination | 2/387 (0.5%) | |
| Hallucination, auditory | 3/387 (0.8%) | |
| Insomnia | 1/387 (0.3%) | |
| Panic attack | 1/387 (0.3%) | |
| Psychiatric symptom | 1/387 (0.3%) | |
| Psychotic disorder | 7/387 (1.8%) | |
| Schizophrenia | 5/387 (1.3%) | |
| Suicide attempt | 3/387 (0.8%) | |
| Surgical and medical procedures | ||
| Cholecystectomy | 1/387 (0.3%) | |
| Gastrectomy | 1/387 (0.3%) | |
Other (Not Including Serious) Adverse Events |
||
| Paliperidone | ||
| Affected / at Risk (%) | # Events | |
| Total | 209/387 (54%) | |
| Endocrine disorders | ||
| Hyperprolactinaemia | 8/387 (2.1%) | |
| Eye disorders | ||
| Oculogyration | 8/387 (2.1%) | |
| Gastrointestinal disorders | ||
| Constipation | 13/387 (3.4%) | |
| Nausea | 11/387 (2.8%) | |
| Infections and infestations | ||
| Nasopharyngitis | 9/387 (2.3%) | |
| Investigations | ||
| Weight decreased | 10/387 (2.6%) | |
| Weight increased | 36/387 (9.3%) | |
| Musculoskeletal and connective tissue disorders | ||
| Muscle rigidity | 15/387 (3.9%) | |
| Nervous system disorders | ||
| Akathisia | 44/387 (11.4%) | |
| Bradykinesia | 9/387 (2.3%) | |
| Dizziness | 16/387 (4.1%) | |
| Extrapyramidal disorder | 8/387 (2.1%) | |
| Headache | 33/387 (8.5%) | |
| Sedation | 10/387 (2.6%) | |
| Somnolence | 20/387 (5.2%) | |
| Tremor | 23/387 (5.9%) | |
| Psychiatric disorders | ||
| Anxiety | 22/387 (5.7%) | |
| Depression | 11/387 (2.8%) | |
| Hallucination, auditory | 8/387 (2.1%) | |
| Insomnia | 48/387 (12.4%) | |
| Reproductive system and breast disorders | ||
| Amenorrhoea | 15/387 (3.9%) | |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
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.
Results Point of Contact
| Name/Title | Senior Clinical Research Associate |
|---|---|
| Organization | Clinical Research Team, Medical Affairs Korea |
| Phone | 82-2-2094-4804 |
- CR015253
- PAL-KOR-4003