Trial Outcomes & Findings for Paliperidone Extended Release(ER) Effectiveness Study to Evaluate the Objective Symptom Change and Symptomatic Remission (NCT NCT00761579)
NCT ID: NCT00761579
Last Updated: 2014-06-03
Results Overview
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.
COMPLETED
PHASE4
190 participants
Baseline and Week 48
2014-06-03
Participant Flow
Participant milestones
| Measure |
Paliperidone
Paliperidone oral tablet was administered once daily at a starting dose of either 3 milligram (mg) for 48 weeks, wherein recommended dose was 6 mg and dose range was 3 to 12 mg per day.
|
|---|---|
|
Overall Study
STARTED
|
190
|
|
Overall Study
COMPLETED
|
98
|
|
Overall Study
NOT COMPLETED
|
92
|
Reasons for withdrawal
| Measure |
Paliperidone
Paliperidone oral tablet was administered once daily at a starting dose of either 3 milligram (mg) for 48 weeks, wherein recommended dose was 6 mg and dose range was 3 to 12 mg per day.
|
|---|---|
|
Overall Study
Adverse Event
|
10
|
|
Overall Study
Death
|
2
|
|
Overall Study
Lack of Efficacy
|
21
|
|
Overall Study
Lost to Follow-up
|
16
|
|
Overall Study
Pregnancy
|
1
|
|
Overall Study
Withdrawal by Subject
|
34
|
|
Overall Study
Lack of compliance
|
2
|
|
Overall Study
Protocol deviation
|
1
|
|
Overall Study
Drug overdose
|
1
|
|
Overall Study
Aggravation of depression
|
1
|
|
Overall Study
Aggravation of symptoms by changing drug
|
1
|
|
Overall Study
Lost survey form
|
1
|
|
Overall Study
Intake of prohibited concomitant drug
|
1
|
Baseline Characteristics
Paliperidone Extended Release(ER) Effectiveness Study to Evaluate the Objective Symptom Change and Symptomatic Remission
Baseline characteristics by cohort
| Measure |
Paliperidone
n=190 Participants
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.
|
|---|---|
|
Daytime Drowsiness
|
45.65 Units on a scale
STANDARD_DEVIATION 29.97 • n=5 Participants
|
|
Sleep Quality
|
61.90 Units on a scale
STANDARD_DEVIATION 27.73 • n=5 Participants
|
|
Age, Continuous
|
33.9 years
STANDARD_DEVIATION 10.54 • n=5 Participants
|
|
Sex: Female, Male
Female
|
93 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
97 Participants
n=5 Participants
|
|
Positive and Negative Syndrome Scale (PANSS) Total Score
|
79.42 Units on a scale
STANDARD_DEVIATION 19.64 • n=5 Participants
|
|
Positive and Negative Syndrome Scale (PANSS) - Positive Subscale Score
|
18.96 Units on a scale
STANDARD_DEVIATION 6.19 • n=5 Participants
|
|
Positive and Negative Syndrome Scale (PANSS) - Negative Subscale Score
|
20.61 Units on a scale
STANDARD_DEVIATION 5.97 • n=5 Participants
|
|
Positive and Negative Syndrome Scale (PANSS) - General Psychopathology Subscale Score
|
18.00 Units on a scale
STANDARD_DEVIATION 5.56 • n=5 Participants
|
|
Personal and Social Performance Scale (PSP) Score
|
54.08 Units on a scale
STANDARD_DEVIATION 14.84 • n=5 Participants
|
|
Drug Attitude Inventory (DAI-10)
|
3.01 Units on a scale
STANDARD_DEVIATION 4.31 • n=5 Participants
|
|
Subjective Well-being Under Neuroleptic (SWN-20) Scale Score
|
73.64 Units on a scale
STANDARD_DEVIATION 16.87 • n=5 Participants
|
|
Symptom Checklist 90-R (SCL90-R)
|
91.72 Units on a scale
STANDARD_DEVIATION 65.10 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 48Population: 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.
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.
Outcome measures
| Measure |
Paliperidone ER: Lack of Efficacy
n=144 Participants
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: Lack of Tolerability
n=21 Participants
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: Lack of Compliance
n=25 Participants
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).
|
|---|---|---|---|
|
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 48
|
11.57 Units on a scale
Standard Deviation 16.95
|
6.43 Units on a scale
Standard Deviation 13.94
|
16.36 Units on a scale
Standard Deviation 17.44
|
PRIMARY outcome
Timeframe: Baseline and Week 48Population: 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.
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.
Outcome measures
| Measure |
Paliperidone ER: Lack of Efficacy
n=144 Participants
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: Lack of Tolerability
n=21 Participants
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: Lack of Compliance
n=25 Participants
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).
|
|---|---|---|---|
|
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Positive Subscale Score at Week 48
|
3.53 Units on a scale
Standard Deviation 5.23
|
1.05 Units on a scale
Standard Deviation 2.75
|
5.00 Units on a scale
Standard Deviation 6.40
|
PRIMARY outcome
Timeframe: Baseline and Week 48Population: 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.
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.
Outcome measures
| Measure |
Paliperidone ER: Lack of Efficacy
n=144 Participants
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: Lack of Tolerability
n=21 Participants
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: Lack of Compliance
n=25 Participants
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).
|
|---|---|---|---|
|
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Negative Subscale Score at Week 48
|
2.53 Units on a scale
Standard Deviation 4.60
|
2.19 Units on a scale
Standard Deviation 4.07
|
3.36 Units on a scale
Standard Deviation 5.51
|
PRIMARY outcome
Timeframe: Baseline and Week 48Population: 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.
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.
Outcome measures
| Measure |
Paliperidone ER: Lack of Efficacy
n=144 Participants
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: Lack of Tolerability
n=21 Participants
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: Lack of Compliance
n=25 Participants
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).
|
|---|---|---|---|
|
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - General Psychopathology Subscale Score at Week 48
|
5.51 Units on a scale
Standard Deviation 9.41
|
3.19 Units on a scale
Standard Deviation 8.68
|
8.00 Units on a scale
Standard Deviation 8.30
|
SECONDARY outcome
Timeframe: Baseline and Week 48Population: 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.
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.
Outcome measures
| Measure |
Paliperidone ER: Lack of Efficacy
n=144 Participants
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: Lack of Tolerability
n=21 Participants
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: Lack of Compliance
n=25 Participants
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).
|
|---|---|---|---|
|
Change From Baseline in Personal and Social Performance Scale (PSP) Score at Week 48
|
-6.73 Units on a scale
Standard Deviation 14.16
|
-2.38 Units on a scale
Standard Deviation 9.86
|
-11.36 Units on a scale
Standard Deviation 13.90
|
SECONDARY outcome
Timeframe: Baseline and Week 48Population: 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.
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.
Outcome measures
| Measure |
Paliperidone ER: Lack of Efficacy
n=140 Participants
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: Lack of Tolerability
n=21 Participants
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: Lack of Compliance
n=24 Participants
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).
|
|---|---|---|---|
|
Change From Baseline in Drug Attitude Inventory (DAI-10) at Week 48
|
-0.01 Units on a scale
Standard Deviation 4.72
|
-0.95 Units on a scale
Standard Deviation 4.27
|
0.08 Units on a scale
Standard Deviation 4.19
|
SECONDARY outcome
Timeframe: Baseline and Week 48Population: 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.
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.
Outcome measures
| Measure |
Paliperidone ER: Lack of Efficacy
n=140 Participants
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: Lack of Tolerability
n=21 Participants
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: Lack of Compliance
n=25 Participants
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).
|
|---|---|---|---|
|
Change From Baseline in Subjective Well-being Under Neuroleptic (SWN-20) Scale Score at Week 48
|
-1.17 Units on a scale
Standard Deviation 14.37
|
-5.05 Units on a scale
Standard Deviation 14.03
|
2.40 Units on a scale
Standard Deviation 11.85
|
SECONDARY outcome
Timeframe: Baseline and Week 48Population: 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.
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.
Outcome measures
| Measure |
Paliperidone ER: Lack of Efficacy
n=140 Participants
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: Lack of Tolerability
n=21 Participants
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: Lack of Compliance
n=25 Participants
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).
|
|---|---|---|---|
|
Change From Baseline in Daytime Drowsiness at Week 48
|
5.40 millimeter (mm)
Standard Deviation 34.11
|
2.10 millimeter (mm)
Standard Deviation 27.76
|
11.40 millimeter (mm)
Standard Deviation 24.61
|
SECONDARY outcome
Timeframe: Baseline and Week 48Population: 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.
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.
Outcome measures
| Measure |
Paliperidone ER: Lack of Efficacy
n=140 Participants
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: Lack of Tolerability
n=21 Participants
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: Lack of Compliance
n=25 Participants
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).
|
|---|---|---|---|
|
Change From Baseline in Sleep Quality at Week 48
|
1.50 millimeter (mm)
Standard Deviation 32.94
|
-7.76 millimeter (mm)
Standard Deviation 31.20
|
3.40 millimeter (mm)
Standard Deviation 35.34
|
SECONDARY outcome
Timeframe: Baseline and Week 48Population: 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.
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.
Outcome measures
| Measure |
Paliperidone ER: Lack of Efficacy
n=140 Participants
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: Lack of Tolerability
n=21 Participants
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: Lack of Compliance
n=25 Participants
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).
|
|---|---|---|---|
|
Change From Baseline in Symptom Checklist 90-R (SCL90-R) at Week 48
|
14.88 Units on a scale
Standard Deviation 48.32
|
12.38 Units on a scale
Standard Deviation 32.01
|
25.44 Units on a scale
Standard Deviation 44.41
|
Adverse Events
Paliperidone
Serious adverse events
| Measure |
Paliperidone
n=190 participants at risk
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.
|
|---|---|
|
Gastrointestinal disorders
Inguinal Hernia
|
0.53%
1/190 • Baseline up to Week 48
Safety population included all the eligible participants who received paliperidone extended-release (ER) at least once .
|
|
General disorders
Asthenia
|
0.53%
1/190 • Baseline up to Week 48
Safety population included all the eligible participants who received paliperidone extended-release (ER) at least once .
|
|
General disorders
Pyrexia
|
0.53%
1/190 • Baseline up to Week 48
Safety population included all the eligible participants who received paliperidone extended-release (ER) at least once .
|
|
Injury, poisoning and procedural complications
Fall
|
0.53%
1/190 • Baseline up to Week 48
Safety population included all the eligible participants who received paliperidone extended-release (ER) at least once .
|
|
Injury, poisoning and procedural complications
Lumbar Vertebral Fracture
|
0.53%
1/190 • Baseline up to Week 48
Safety population included all the eligible participants who received paliperidone extended-release (ER) at least once .
|
|
Injury, poisoning and procedural complications
Overdose
|
0.53%
1/190 • Baseline up to Week 48
Safety population included all the eligible participants who received paliperidone extended-release (ER) at least once .
|
|
Injury, poisoning and procedural complications
Subdural Haemorrhage
|
0.53%
1/190 • Baseline up to Week 48
Safety population included all the eligible participants who received paliperidone extended-release (ER) at least once .
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
0.53%
1/190 • Baseline up to Week 48
Safety population included all the eligible participants who received paliperidone extended-release (ER) at least once .
|
|
Nervous system disorders
Syncope
|
0.53%
1/190 • Baseline up to Week 48
Safety population included all the eligible participants who received paliperidone extended-release (ER) at least once .
|
|
Psychiatric disorders
Agitated Depression
|
0.53%
1/190 • Baseline up to Week 48
Safety population included all the eligible participants who received paliperidone extended-release (ER) at least once .
|
|
Psychiatric disorders
Alcoholism
|
0.53%
1/190 • Baseline up to Week 48
Safety population included all the eligible participants who received paliperidone extended-release (ER) at least once .
|
|
Psychiatric disorders
Anxiety
|
0.53%
1/190 • Baseline up to Week 48
Safety population included all the eligible participants who received paliperidone extended-release (ER) at least once .
|
|
Psychiatric disorders
Completed Suicide
|
1.1%
2/190 • Baseline up to Week 48
Safety population included all the eligible participants who received paliperidone extended-release (ER) at least once .
|
|
Psychiatric disorders
Confusional State
|
0.53%
1/190 • Baseline up to Week 48
Safety population included all the eligible participants who received paliperidone extended-release (ER) at least once .
|
|
Psychiatric disorders
Depressive Symptom
|
1.1%
2/190 • Baseline up to Week 48
Safety population included all the eligible participants who received paliperidone extended-release (ER) at least once .
|
|
Psychiatric disorders
Hallucination, Auditory
|
0.53%
1/190 • Baseline up to Week 48
Safety population included all the eligible participants who received paliperidone extended-release (ER) at least once .
|
|
Psychiatric disorders
Persecutory Delusion
|
0.53%
1/190 • Baseline up to Week 48
Safety population included all the eligible participants who received paliperidone extended-release (ER) at least once .
|
|
Psychiatric disorders
Schizophrenia
|
3.2%
6/190 • Baseline up to Week 48
Safety population included all the eligible participants who received paliperidone extended-release (ER) at least once .
|
|
Psychiatric disorders
Suicidal Behaviour
|
0.53%
1/190 • Baseline up to Week 48
Safety population included all the eligible participants who received paliperidone extended-release (ER) at least once .
|
|
Psychiatric disorders
Suicide Attempt
|
1.1%
2/190 • Baseline up to Week 48
Safety population included all the eligible participants who received paliperidone extended-release (ER) at least once .
|
Other adverse events
| Measure |
Paliperidone
n=190 participants at risk
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.
|
|---|---|
|
Endocrine disorders
Hyperprolactinaemia
|
5.8%
11/190 • Baseline up to Week 48
Safety population included all the eligible participants who received paliperidone extended-release (ER) at least once .
|
|
Eye disorders
Vision Blurred
|
2.1%
4/190 • Baseline up to Week 48
Safety population included all the eligible participants who received paliperidone extended-release (ER) at least once .
|
|
Gastrointestinal disorders
Constipation
|
3.2%
6/190 • Baseline up to Week 48
Safety population included all the eligible participants who received paliperidone extended-release (ER) at least once .
|
|
Gastrointestinal disorders
Dry Mouth
|
3.7%
7/190 • Baseline up to Week 48
Safety population included all the eligible participants who received paliperidone extended-release (ER) at least once .
|
|
Gastrointestinal disorders
Dyspepsia
|
2.1%
4/190 • Baseline up to Week 48
Safety population included all the eligible participants who received paliperidone extended-release (ER) at least once .
|
|
Gastrointestinal disorders
Vomiting
|
2.1%
4/190 • Baseline up to Week 48
Safety population included all the eligible participants who received paliperidone extended-release (ER) at least once .
|
|
General disorders
Fatigue
|
3.7%
7/190 • Baseline up to Week 48
Safety population included all the eligible participants who received paliperidone extended-release (ER) at least once .
|
|
General disorders
Gait Disturbance
|
2.6%
5/190 • Baseline up to Week 48
Safety population included all the eligible participants who received paliperidone extended-release (ER) at least once .
|
|
Investigations
Weight Decreased
|
2.6%
5/190 • Baseline up to Week 48
Safety population included all the eligible participants who received paliperidone extended-release (ER) at least once .
|
|
Investigations
Weight Increased
|
15.3%
29/190 • Baseline up to Week 48
Safety population included all the eligible participants who received paliperidone extended-release (ER) at least once .
|
|
Musculoskeletal and connective tissue disorders
Muscle Rigidity
|
7.4%
14/190 • Baseline up to Week 48
Safety population included all the eligible participants who received paliperidone extended-release (ER) at least once .
|
|
Nervous system disorders
Akathisia
|
18.4%
35/190 • Baseline up to Week 48
Safety population included all the eligible participants who received paliperidone extended-release (ER) at least once .
|
|
Nervous system disorders
Bradykinesia
|
5.8%
11/190 • Baseline up to Week 48
Safety population included all the eligible participants who received paliperidone extended-release (ER) at least once .
|
|
Nervous system disorders
Dizziness
|
4.2%
8/190 • Baseline up to Week 48
Safety population included all the eligible participants who received paliperidone extended-release (ER) at least once .
|
|
Nervous system disorders
Dysarthria
|
2.6%
5/190 • Baseline up to Week 48
Safety population included all the eligible participants who received paliperidone extended-release (ER) at least once .
|
|
Nervous system disorders
Dyskinesia
|
2.6%
5/190 • Baseline up to Week 48
Safety population included all the eligible participants who received paliperidone extended-release (ER) at least once .
|
|
Nervous system disorders
Dystonia
|
3.2%
6/190 • Baseline up to Week 48
Safety population included all the eligible participants who received paliperidone extended-release (ER) at least once .
|
|
Nervous system disorders
Headache
|
2.6%
5/190 • Baseline up to Week 48
Safety population included all the eligible participants who received paliperidone extended-release (ER) at least once .
|
|
Nervous system disorders
Paraesthesia
|
2.1%
4/190 • Baseline up to Week 48
Safety population included all the eligible participants who received paliperidone extended-release (ER) at least once .
|
|
Nervous system disorders
Sedation
|
3.2%
6/190 • Baseline up to Week 48
Safety population included all the eligible participants who received paliperidone extended-release (ER) at least once .
|
|
Nervous system disorders
Somnolence
|
3.7%
7/190 • Baseline up to Week 48
Safety population included all the eligible participants who received paliperidone extended-release (ER) at least once .
|
|
Nervous system disorders
Tremor
|
7.4%
14/190 • Baseline up to Week 48
Safety population included all the eligible participants who received paliperidone extended-release (ER) at least once .
|
|
Psychiatric disorders
Anxiety
|
2.1%
4/190 • Baseline up to Week 48
Safety population included all the eligible participants who received paliperidone extended-release (ER) at least once .
|
|
Psychiatric disorders
Insomnia
|
6.8%
13/190 • Baseline up to Week 48
Safety population included all the eligible participants who received paliperidone extended-release (ER) at least once .
|
|
Reproductive system and breast disorders
Amenorrhoea
|
3.7%
7/190 • Baseline up to Week 48
Safety population included all the eligible participants who received paliperidone extended-release (ER) at least once .
|
Additional Information
Senior Clinical Research Associate
Clinical Research Team, Medical Affairs Korea
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60