Trial Outcomes & Findings for Study to Measure Drug Satisfaction of Patients With Schizophrenia After Switching From Risperidone to Paliperidone (NCT NCT00535132)
NCT ID: NCT00535132
Last Updated: 2014-05-09
Results Overview
The MSQ is a 7-point, verbally administered, Likert-type scale rated as follows: 1=Extremely Dissatisfied, 2=Very Dissatisfied, 3=Somewhat Dissatisfied, 4=Neither Satisfied Nor Dissatisfied, 5=Somewhat Satisfied, 6=Very Satisfied, 7=Extremely Satisfied. Worst value is 1 (Extremely Dissatisfied) and best value is 7 (Extremely Satisfied).
COMPLETED
PHASE4
201 participants
Change from Baseline in MSQ Score at Week 6 Last Observation Carried Forward (LOCF)
2014-05-09
Participant Flow
Participant milestones
| Measure |
PALI ER Immediate Initiation
Subjects randomly assigned at the baseline visit to an immediate initiation of paliperidone ER from oral risperidone were to receive blinded paliperidone ER for a total of 6 weeks (Immediate Initiation group).
|
PALI ER Delayed Initiation
Subjects randomly assigned to a delayed initiation were to receive blinded resperidone at their baseline dose of 4 or 6 mg for 2 weeks and were to be initiated on blinded paliperidone ER at Day 14 for 4 weeks (Delayed Initiation group).
|
|---|---|---|
|
Randomized Population
STARTED
|
100
|
101
|
|
Randomized Population
COMPLETED
|
100
|
101
|
|
Randomized Population
NOT COMPLETED
|
0
|
0
|
|
Safety Analysis Set
STARTED
|
100
|
101
|
|
Safety Analysis Set
COMPLETED
|
98
|
99
|
|
Safety Analysis Set
NOT COMPLETED
|
2
|
2
|
|
Intent-to-Treat (ITT) Analysis Set
STARTED
|
98
|
99
|
|
Intent-to-Treat (ITT) Analysis Set
COMPLETED
|
95
|
96
|
|
Intent-to-Treat (ITT) Analysis Set
NOT COMPLETED
|
3
|
3
|
Reasons for withdrawal
| Measure |
PALI ER Immediate Initiation
Subjects randomly assigned at the baseline visit to an immediate initiation of paliperidone ER from oral risperidone were to receive blinded paliperidone ER for a total of 6 weeks (Immediate Initiation group).
|
PALI ER Delayed Initiation
Subjects randomly assigned to a delayed initiation were to receive blinded resperidone at their baseline dose of 4 or 6 mg for 2 weeks and were to be initiated on blinded paliperidone ER at Day 14 for 4 weeks (Delayed Initiation group).
|
|---|---|---|
|
Safety Analysis Set
Did Not Receive Study Medication
|
2
|
2
|
|
Intent-to-Treat (ITT) Analysis Set
No Follow-up Efficacy Data
|
3
|
3
|
Baseline Characteristics
Study to Measure Drug Satisfaction of Patients With Schizophrenia After Switching From Risperidone to Paliperidone
Baseline characteristics by cohort
| Measure |
PALI ER Immediate Initiation
n=98 Participants
Subjects randomly assigned at the baseline visit to an immediate initiation of paliperidone ER from oral risperidone were to receive blinded paliperidone ER for a total of 6 weeks (Immediate Initiation group).
|
PALI ER Delayed Initiation
n=99 Participants
Subjects randomly assigned to a delayed initiation were to receive blinded resperidone at their baseline dose of 4 or 6 mg for 2 weeks and were then to be initiated on blinded paliperidone ER at Day 14 for 4 weeks (Delayed Initiation group).
|
Total
n=197 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
41.1 years
STANDARD_DEVIATION 12.5 • n=99 Participants
|
40.2 years
STANDARD_DEVIATION 11.4 • n=107 Participants
|
40.6 years
STANDARD_DEVIATION 11.9 • n=206 Participants
|
|
Sex/Gender, Customized
Male
|
58 participants
n=99 Participants
|
53 participants
n=107 Participants
|
111 participants
n=206 Participants
|
|
Sex/Gender, Customized
Female
|
40 participants
n=99 Participants
|
46 participants
n=107 Participants
|
86 participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
31 Participants
n=99 Participants
|
26 Participants
n=107 Participants
|
57 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
61 Participants
n=99 Participants
|
69 Participants
n=107 Participants
|
130 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Change from Baseline in MSQ Score at Week 6 Last Observation Carried Forward (LOCF)Population: Intent-to-Treat Population with non-missing values at this timepoint
The MSQ is a 7-point, verbally administered, Likert-type scale rated as follows: 1=Extremely Dissatisfied, 2=Very Dissatisfied, 3=Somewhat Dissatisfied, 4=Neither Satisfied Nor Dissatisfied, 5=Somewhat Satisfied, 6=Very Satisfied, 7=Extremely Satisfied. Worst value is 1 (Extremely Dissatisfied) and best value is 7 (Extremely Satisfied).
Outcome measures
| Measure |
PALI ER Immediate Initiation
n=95 Participants
Subjects randomly assigned at the baseline visit to an immediate initiation of paliperidone ER from oral risperidone were to receive blinded paliperidone ER for a total of 6 weeks (Immediate Initiation group).
|
PALI ER Delayed Initiation
n=96 Participants
Subjects randomly assigned to a delayed initiation were to receive blinded resperidone at their baseline dose of 4 or 6 mg for 2 weeks and were to be initiated on blinded paliperidone ER at Day 14 for 4 weeks (Delayed Initiation group).
|
Overall
n=191 Participants
Combined subjects in the paliperidone ER Immediate Initiation and paliperidone ER Delayed Initiation groups.
|
|---|---|---|---|
|
Medication Satisfaction Questionnaire (MSQ) Score Change From Baseline to the Week 6 Endpoint.
|
2.5 Points on a scale
Standard Deviation 1.2
|
2.3 Points on a scale
Standard Deviation 1.5
|
2.4 Points on a scale
Standard Deviation 1.4
|
SECONDARY outcome
Timeframe: Change from Baseline in MSQ Score at Week 2Population: Intent-to-Treat Population with non-missing values at this timepoint
The MSQ is a 7-point, verbally administered, Likert-type scale rated as follows: 1=Extremely Dissatisfied, 2=Very Dissatisfied, 3=Somewhat Dissatisfied, 4=Neither Satisfied Nor Dissatisfied, 5=Somewhat Satisfied, 6=Very Satisfied, 7=Extremely Satisfied. Worst value is 1 (Extremely Dissatisfied) and best value is 7 (Extremely Satisfied).
Outcome measures
| Measure |
PALI ER Immediate Initiation
n=93 Participants
Subjects randomly assigned at the baseline visit to an immediate initiation of paliperidone ER from oral risperidone were to receive blinded paliperidone ER for a total of 6 weeks (Immediate Initiation group).
|
PALI ER Delayed Initiation
n=95 Participants
Subjects randomly assigned to a delayed initiation were to receive blinded resperidone at their baseline dose of 4 or 6 mg for 2 weeks and were to be initiated on blinded paliperidone ER at Day 14 for 4 weeks (Delayed Initiation group).
|
Overall
n=188 Participants
Combined subjects in the paliperidone ER Immediate Initiation and paliperidone ER Delayed Initiation groups.
|
|---|---|---|---|
|
Medication Satisfaction Questionnaire (MSQ) Score Change From Baseline to Week 2 (Observed).
|
2.0 Points on a scale
Standard Deviation 1.4
|
1.6 Points on a scale
Standard Deviation 1.4
|
1.8 Points on a scale
Standard Deviation 1.4
|
SECONDARY outcome
Timeframe: Change from Baseline in MSQ Score at Week 4Population: Intent-to-Treat Population with non-missing values at this timepoint
The MSQ is a 7-point, verbally administered, Likert-type scale rated as follows: 1=Extremely Dissatisfied, 2=Very Dissatisfied, 3=Somewhat Dissatisfied, 4=Neither Satisfied Nor Dissatisfied, 5=Somewhat Satisfied, 6=Very Satisfied, 7=Extremely Satisfied. Worst value is 1 (Extremely Dissatisfied) and best value is 7 (Extremely Satisfied).
Outcome measures
| Measure |
PALI ER Immediate Initiation
n=89 Participants
Subjects randomly assigned at the baseline visit to an immediate initiation of paliperidone ER from oral risperidone were to receive blinded paliperidone ER for a total of 6 weeks (Immediate Initiation group).
|
PALI ER Delayed Initiation
n=91 Participants
Subjects randomly assigned to a delayed initiation were to receive blinded resperidone at their baseline dose of 4 or 6 mg for 2 weeks and were to be initiated on blinded paliperidone ER at Day 14 for 4 weeks (Delayed Initiation group).
|
Overall
n=180 Participants
Combined subjects in the paliperidone ER Immediate Initiation and paliperidone ER Delayed Initiation groups.
|
|---|---|---|---|
|
Medication Satisfaction Questionnaire (MSQ) Score Change From Baseline to Week 4 (Observed).
|
2.4 Points on a scale
Standard Deviation 1.2
|
2.1 Points on a scale
Standard Deviation 1.5
|
2.3 Points on a scale
Standard Deviation 1.4
|
SECONDARY outcome
Timeframe: Change from Baseline in MSQ Score at Week 6Population: Intent-to-Treat Population with non-missing values at this timepoint
The MSQ is a 7-point, verbally administered, Likert-type scale rated as follows: 1=Extremely Dissatisfied, 2=Very Dissatisfied, 3=Somewhat Dissatisfied, 4=Neither Satisfied Nor Dissatisfied, 5=Somewhat Satisfied, 6=Very Satisfied, 7=Extremely Satisfied. Worst value is 1 (Extremely Dissatisfied) and best value is 7 (Extremely Satisfied).
Outcome measures
| Measure |
PALI ER Immediate Initiation
n=85 Participants
Subjects randomly assigned at the baseline visit to an immediate initiation of paliperidone ER from oral risperidone were to receive blinded paliperidone ER for a total of 6 weeks (Immediate Initiation group).
|
PALI ER Delayed Initiation
n=87 Participants
Subjects randomly assigned to a delayed initiation were to receive blinded resperidone at their baseline dose of 4 or 6 mg for 2 weeks and were to be initiated on blinded paliperidone ER at Day 14 for 4 weeks (Delayed Initiation group).
|
Overall
n=172 Participants
Combined subjects in the paliperidone ER Immediate Initiation and paliperidone ER Delayed Initiation groups.
|
|---|---|---|---|
|
Medication Satisfaction Questionnaire (MSQ) Score Change From Baseline to Week 6 (Observed).
|
2.5 Points on a scale
Standard Deviation 1.2
|
2.4 Points on a scale
Standard Deviation 1.3
|
2.5 Points on a scale
Standard Deviation 1.3
|
SECONDARY outcome
Timeframe: Week 2Population: Intent-to-Treat Population with non-missing values at this timepoint
The MSQ is a 7-point, verbally administered, Likert-type scale rated as follows: 1=Extremely Dissatisfied, 2=Very Dissatisfied, 3=Somewhat Dissatisfied, 4=Neither Satisfied Nor Dissatisfied, 5=Somewhat Satisfied, 6=Very Satisfied, 7=Extremely Satisfied. Worst value is 1 (Extremely Dissatisfied) and best value is 7 (Extremely Satisfied).
Outcome measures
| Measure |
PALI ER Immediate Initiation
n=93 Participants
Subjects randomly assigned at the baseline visit to an immediate initiation of paliperidone ER from oral risperidone were to receive blinded paliperidone ER for a total of 6 weeks (Immediate Initiation group).
|
PALI ER Delayed Initiation
n=95 Participants
Subjects randomly assigned to a delayed initiation were to receive blinded resperidone at their baseline dose of 4 or 6 mg for 2 weeks and were to be initiated on blinded paliperidone ER at Day 14 for 4 weeks (Delayed Initiation group).
|
Overall
n=188 Participants
Combined subjects in the paliperidone ER Immediate Initiation and paliperidone ER Delayed Initiation groups.
|
|---|---|---|---|
|
Medication Satisfaction Questionnaire (MSQ) - Categorical Summary - Dichotomized Categories - Week 2 (Observed).
Satisfied (score 5-7)
|
63 Participants
|
43 Participants
|
106 Participants
|
|
Medication Satisfaction Questionnaire (MSQ) - Categorical Summary - Dichotomized Categories - Week 2 (Observed).
Dissatisfied (score 1-4)
|
30 Participants
|
52 Participants
|
82 Participants
|
SECONDARY outcome
Timeframe: Week 4Population: Intent-to-Treat Population with non-missing values at this timepoint
The MSQ is a 7-point, verbally administered, Likert-type scale rated as follows: 1=Extremely Dissatisfied, 2=Very Dissatisfied, 3=Somewhat Dissatisfied, 4=Neither Satisfied Nor Dissatisfied, 5=Somewhat Satisfied, 6=Very Satisfied, 7=Extremely Satisfied. Worst value is 1 (Extremely Dissatisfied) and best value is 7 (Extremely Satisfied).
Outcome measures
| Measure |
PALI ER Immediate Initiation
n=89 Participants
Subjects randomly assigned at the baseline visit to an immediate initiation of paliperidone ER from oral risperidone were to receive blinded paliperidone ER for a total of 6 weeks (Immediate Initiation group).
|
PALI ER Delayed Initiation
n=91 Participants
Subjects randomly assigned to a delayed initiation were to receive blinded resperidone at their baseline dose of 4 or 6 mg for 2 weeks and were to be initiated on blinded paliperidone ER at Day 14 for 4 weeks (Delayed Initiation group).
|
Overall
n=180 Participants
Combined subjects in the paliperidone ER Immediate Initiation and paliperidone ER Delayed Initiation groups.
|
|---|---|---|---|
|
Medication Satisfaction Questionnaire (MSQ) - Categorical Summary - Dichotomized Categories - Week 4 (Observed).
Satisfied (score 5-7)
|
75 Participants
|
64 Participants
|
139 Participants
|
|
Medication Satisfaction Questionnaire (MSQ) - Categorical Summary - Dichotomized Categories - Week 4 (Observed).
Dissatisfied (score 1-4)
|
14 Participants
|
27 Participants
|
41 Participants
|
SECONDARY outcome
Timeframe: Week 6Population: Intent-to-Treat Population with non-missing values at this timepoint
The MSQ is a 7-point, verbally administered, Likert-type scale rated as follows: 1=Extremely Dissatisfied, 2=Very Dissatisfied, 3=Somewhat Dissatisfied, 4=Neither Satisfied Nor Dissatisfied, 5=Somewhat Satisfied, 6=Very Satisfied, 7=Extremely Satisfied. Worst value is 1 (Extremely Dissatisfied) and best value is 7 (Extremely Satisfied).
Outcome measures
| Measure |
PALI ER Immediate Initiation
n=85 Participants
Subjects randomly assigned at the baseline visit to an immediate initiation of paliperidone ER from oral risperidone were to receive blinded paliperidone ER for a total of 6 weeks (Immediate Initiation group).
|
PALI ER Delayed Initiation
n=87 Participants
Subjects randomly assigned to a delayed initiation were to receive blinded resperidone at their baseline dose of 4 or 6 mg for 2 weeks and were to be initiated on blinded paliperidone ER at Day 14 for 4 weeks (Delayed Initiation group).
|
Overall
n=172 Participants
Combined subjects in the paliperidone ER Immediate Initiation and paliperidone ER Delayed Initiation groups.
|
|---|---|---|---|
|
Medication Satisfaction Questionnaire (MSQ) - Categorical Summary - Dichotomized Categories - Week 6 (Observed).
Dissatisfied (score 1-4)
|
8 Participants
|
16 Participants
|
24 Participants
|
|
Medication Satisfaction Questionnaire (MSQ) - Categorical Summary - Dichotomized Categories - Week 6 (Observed).
Satisfied (score 5-7)
|
77 Participants
|
71 Participants
|
148 Participants
|
SECONDARY outcome
Timeframe: Week 6 LOCFPopulation: Intent-to-Treat Population with non-missing values at this timepoint
The MSQ is a 7-point, verbally administered, Likert-type scale rated as follows: 1=Extremely Dissatisfied, 2=Very Dissatisfied, 3=Somewhat Dissatisfied, 4=Neither Satisfied Nor Dissatisfied, 5=Somewhat Satisfied, 6=Very Satisfied, 7=Extremely Satisfied. Worst value is 1 (Extremely Dissatisfied) and best value is 7 (Extremely Satisfied).
Outcome measures
| Measure |
PALI ER Immediate Initiation
n=95 Participants
Subjects randomly assigned at the baseline visit to an immediate initiation of paliperidone ER from oral risperidone were to receive blinded paliperidone ER for a total of 6 weeks (Immediate Initiation group).
|
PALI ER Delayed Initiation
n=96 Participants
Subjects randomly assigned to a delayed initiation were to receive blinded resperidone at their baseline dose of 4 or 6 mg for 2 weeks and were to be initiated on blinded paliperidone ER at Day 14 for 4 weeks (Delayed Initiation group).
|
Overall
n=191 Participants
Combined subjects in the paliperidone ER Immediate Initiation and paliperidone ER Delayed Initiation groups.
|
|---|---|---|---|
|
Medication Satisfaction Questionnaire (MSQ) - Categorical Summary - Dichotomized Categories - Week 6 LOCF.
Satisfied (score 5-7)
|
83 Participants
|
75 Participants
|
158 Participants
|
|
Medication Satisfaction Questionnaire (MSQ) - Categorical Summary - Dichotomized Categories - Week 6 LOCF.
Dissatisfied (score 1-4)
|
12 Participants
|
21 Participants
|
33 Participants
|
SECONDARY outcome
Timeframe: Change from Baseline to Week 6 LOCFPopulation: Intent-to-Treat Population with non-missing values at this timepoint
The TSQM is a 14-item subject-assessed evaluation of treatment medication including 4 factors, Effectiveness (items 1-3), Side Effects (items 4-8), Convenience (items 9-11)and Global Satisfaction (items 12-14). Item 14 states "taking all things into account, how satisfied or dissatisfied are you with this medication?" and utilizes the following responses on a 7-point Likert scale: 1=Extremely Dissatisfied, 2=Very Dissatisfied, 3=Somewhat Dissatisfied, 4=Neither Satisfied Nor Dissatisfied, 5=Somewhat Satisfied, 6=Very Satisfied, 7=Extremely Satisfied. Worst value is 0 and best value is 100.
Outcome measures
| Measure |
PALI ER Immediate Initiation
n=95 Participants
Subjects randomly assigned at the baseline visit to an immediate initiation of paliperidone ER from oral risperidone were to receive blinded paliperidone ER for a total of 6 weeks (Immediate Initiation group).
|
PALI ER Delayed Initiation
n=96 Participants
Subjects randomly assigned to a delayed initiation were to receive blinded resperidone at their baseline dose of 4 or 6 mg for 2 weeks and were to be initiated on blinded paliperidone ER at Day 14 for 4 weeks (Delayed Initiation group).
|
Overall
n=191 Participants
Combined subjects in the paliperidone ER Immediate Initiation and paliperidone ER Delayed Initiation groups.
|
|---|---|---|---|
|
Treatment Satisfaction Questionnaire for Medication (TSQM) Global Satisfaction Score Change From Baseline to the Week 6 Endpoint
|
30.2 Points on a scale
Standard Deviation 22.6
|
26.4 Points on a scale
Standard Deviation 23.6
|
28.3 Points on a scale
Standard Deviation 23.1
|
SECONDARY outcome
Timeframe: Change from Baseline to Week 6 LOCFPopulation: Intent-to-Treat Population with non-missing values at this timepoint
The SF-36 is a well-validated and widely used quality-of-life instrument employed in numerous disease states, including schizophrenia. It is a self-administered survey that measures eight domains of health including: physical functioning, role limitations due to physical health (role-physical), bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems (role-emotional) and general mental health. Scoring of the SF-36 was based on the SF-36 Manual and Interpretation Guide. Worst value is 0 and best value is 100.
Outcome measures
| Measure |
PALI ER Immediate Initiation
n=88 Participants
Subjects randomly assigned at the baseline visit to an immediate initiation of paliperidone ER from oral risperidone were to receive blinded paliperidone ER for a total of 6 weeks (Immediate Initiation group).
|
PALI ER Delayed Initiation
n=91 Participants
Subjects randomly assigned to a delayed initiation were to receive blinded resperidone at their baseline dose of 4 or 6 mg for 2 weeks and were to be initiated on blinded paliperidone ER at Day 14 for 4 weeks (Delayed Initiation group).
|
Overall
n=179 Participants
Combined subjects in the paliperidone ER Immediate Initiation and paliperidone ER Delayed Initiation groups.
|
|---|---|---|---|
|
Short Form-36 Health Survey (SF-36) Physical Health Composite Score Change From Baseline to the Week 6 Endpoint
|
0.8 Scores on a scale
Standard Deviation 8.4
|
2.1 Scores on a scale
Standard Deviation 6.4
|
1.5 Scores on a scale
Standard Deviation 7.5
|
SECONDARY outcome
Timeframe: Change from Baseline to Week 6 LOCFPopulation: Intent-to-Treat Population with non-missing values at this timepoint
The SF-36 is a well-validated and widely used quality-of-life instrument employed in numerous disease states, including schizophrenia. It is a self-administered survey that measures eight domains of health including: physical functioning, role limitations due to physical health (role-physical), bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems (role-emotional) and general mental health. Scoring of the SF-36 was based on the SF-36 Manual and Interpretation Guide. Worst value is 0 and best value is 100.
Outcome measures
| Measure |
PALI ER Immediate Initiation
n=88 Participants
Subjects randomly assigned at the baseline visit to an immediate initiation of paliperidone ER from oral risperidone were to receive blinded paliperidone ER for a total of 6 weeks (Immediate Initiation group).
|
PALI ER Delayed Initiation
n=91 Participants
Subjects randomly assigned to a delayed initiation were to receive blinded resperidone at their baseline dose of 4 or 6 mg for 2 weeks and were to be initiated on blinded paliperidone ER at Day 14 for 4 weeks (Delayed Initiation group).
|
Overall
n=179 Participants
Combined subjects in the paliperidone ER Immediate Initiation and paliperidone ER Delayed Initiation groups.
|
|---|---|---|---|
|
Short Form-36 Health Survey (SF-36) Mental Health Composite Score Change From Baseline to the Week 6 Endpoint
|
6.7 Scores on a scale
Standard Deviation 10.3
|
7.2 Scores on a scale
Standard Deviation 10.6
|
7.0 Scores on a scale
Standard Deviation 10.4
|
SECONDARY outcome
Timeframe: Change from Baseline to Week 6 LOCFPopulation: Intent-to-Treat Population with non-missing values at this timepoint
The PSQI is a 2-part questionnaire that assesses sleep quality and disturbances in seven domains: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction. Each domain is rated on a 4-point scale as follows: 0=Not during the past month, 1=Less than once a week, 2=Once or twice a week, 3=Three or more times a week. Total scores range from zero to 21; increasing scores indicate poorer sleep quality and total scores greater than 5 suggest significant sleep disturbance.
Outcome measures
| Measure |
PALI ER Immediate Initiation
n=84 Participants
Subjects randomly assigned at the baseline visit to an immediate initiation of paliperidone ER from oral risperidone were to receive blinded paliperidone ER for a total of 6 weeks (Immediate Initiation group).
|
PALI ER Delayed Initiation
n=84 Participants
Subjects randomly assigned to a delayed initiation were to receive blinded resperidone at their baseline dose of 4 or 6 mg for 2 weeks and were to be initiated on blinded paliperidone ER at Day 14 for 4 weeks (Delayed Initiation group).
|
Overall
n=168 Participants
Combined subjects in the paliperidone ER Immediate Initiation and paliperidone ER Delayed Initiation groups.
|
|---|---|---|---|
|
Pittsburgh Sleep Quality Index (PSQI) Change From Baseline to the Week 6 Endpoint
|
-2.3 Points on a scale
Standard Deviation 4.3
|
-2.2 Points on a scale
Standard Deviation 4.4
|
-2.3 Points on a scale
Standard Deviation 4.3
|
SECONDARY outcome
Timeframe: Change from Baseline to Week 6 LOCFPopulation: Intent-to-Treat Population with non-missing values at this timepoint
The standard COVI Anxiety Scale is an investigator-assessed measure of the severity of anxiety symptoms on 4 items: verbal report, behavior, somatic symptoms, and relationship to study drug. Each dimension is assessed in 5 to 10 minutes using a 5-point scale as follows: 1=Not at all, 2=Somewhat, 3=Moderately, 4=Considerably, to 5=Very much. For this study, the standard COVI Anxiety Scale was modified to improve psychometric properties by incorporating anchor points for symptom severity, frequency, and duration and for functional impairment. Worst value is 20 and best value is 4.
Outcome measures
| Measure |
PALI ER Immediate Initiation
n=88 Participants
Subjects randomly assigned at the baseline visit to an immediate initiation of paliperidone ER from oral risperidone were to receive blinded paliperidone ER for a total of 6 weeks (Immediate Initiation group).
|
PALI ER Delayed Initiation
n=80 Participants
Subjects randomly assigned to a delayed initiation were to receive blinded resperidone at their baseline dose of 4 or 6 mg for 2 weeks and were to be initiated on blinded paliperidone ER at Day 14 for 4 weeks (Delayed Initiation group).
|
Overall
n=168 Participants
Combined subjects in the paliperidone ER Immediate Initiation and paliperidone ER Delayed Initiation groups.
|
|---|---|---|---|
|
Modified COVI Anxiety Scale (m-COVI) Change From Baseline to the Week 6 Endpoint
|
-1.4 Points on a scale
Standard Deviation 2.8
|
-1.3 Points on a scale
Standard Deviation 3.2
|
-1.3 Points on a scale
Standard Deviation 3.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Change from Baseline to Week 6 LOCFPopulation: Intent-to-Treat Population with non-missing values at this timepoint
The PANSS is a 30-item scale designed to capture numerous symptoms of schizophrenia, including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale as follows: 1=Absent, 2=Minimal, 3=Mild,4=Moderate, 5=Moderate Severe, 6=Severe, 7=Extreme. This scale has been shown to be sensitive to changes associated with medication treatment. In addition to a total score, this assessment yields separate scores along a Positive Syndrome, a Negative Syndrome, and a General Psychopathology Scales. Worst value is 210, best value is 30.
Outcome measures
| Measure |
PALI ER Immediate Initiation
n=95 Participants
Subjects randomly assigned at the baseline visit to an immediate initiation of paliperidone ER from oral risperidone were to receive blinded paliperidone ER for a total of 6 weeks (Immediate Initiation group).
|
PALI ER Delayed Initiation
n=96 Participants
Subjects randomly assigned to a delayed initiation were to receive blinded resperidone at their baseline dose of 4 or 6 mg for 2 weeks and were to be initiated on blinded paliperidone ER at Day 14 for 4 weeks (Delayed Initiation group).
|
Overall
n=191 Participants
Combined subjects in the paliperidone ER Immediate Initiation and paliperidone ER Delayed Initiation groups.
|
|---|---|---|---|
|
Positive and Negative Syndrome Scale (PANSS) Total Score Change From Baseline to Week 6 Endpoint
|
-13.5 Points on a scale
Standard Deviation 12.2
|
-12.3 Points on a scale
Standard Deviation 14.0
|
-12.9 Points on a scale
Standard Deviation 13.1
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Change from Baseline to Week 6 LOCFPopulation: Intent-to-Treat Population with non-missing values at this timepoint
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 subject. 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 subjects". Worst value is 7 and best value is 1.
Outcome measures
| Measure |
PALI ER Immediate Initiation
n=95 Participants
Subjects randomly assigned at the baseline visit to an immediate initiation of paliperidone ER from oral risperidone were to receive blinded paliperidone ER for a total of 6 weeks (Immediate Initiation group).
|
PALI ER Delayed Initiation
n=96 Participants
Subjects randomly assigned to a delayed initiation were to receive blinded resperidone at their baseline dose of 4 or 6 mg for 2 weeks and were to be initiated on blinded paliperidone ER at Day 14 for 4 weeks (Delayed Initiation group).
|
Overall
n=191 Participants
Combined subjects in the paliperidone ER Immediate Initiation and paliperidone ER Delayed Initiation groups.
|
|---|---|---|---|
|
Clinical Global Impression - Severity (CGI-S) Change From Baseline to Week 6 Endpoint
|
-0.8 Points on a scale
Standard Deviation 0.9
|
-0.8 Points on a scale
Standard Deviation 1.0
|
-0.8 Points on a scale
Standard Deviation 0.9
|
Adverse Events
PALI ER Immediate Initiation
PALI ER Delayed Initiation
Overall
Serious adverse events
| Measure |
PALI ER Immediate Initiation
n=98 participants at risk
Subjects randomly assigned at the baseline visit to an immediate initiation of paliperidone ER from oral risperidone were to receive blinded paliperidone ER for a total of 6 weeks (Immediate Initiation group).
|
PALI ER Delayed Initiation
n=99 participants at risk
Subjects randomly assigned to a delayed initiation were to receive blinded resperidone at their baseline dose of 4 or 6 mg for 2 weeks and were to be initiated on blinded paliperidone ER at Day 14 for 4 weeks (Delayed Initiation group).
|
Overall
n=197 participants at risk
Combined subjects in the paliperidone ER Immediate Initiation and paliperidone ER Delayed Initiation groups.
|
|---|---|---|---|
|
Gastrointestinal disorders
Pancreatitis acute
|
1.0%
1/98
|
0.00%
0/99
|
0.51%
1/197
|
|
Psychiatric disorders
Schizophrenia
|
2.0%
2/98
|
4.0%
4/99
|
3.0%
6/197
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
1.0%
1/98
|
0.00%
0/99
|
0.51%
1/197
|
Other adverse events
| Measure |
PALI ER Immediate Initiation
n=98 participants at risk
Subjects randomly assigned at the baseline visit to an immediate initiation of paliperidone ER from oral risperidone were to receive blinded paliperidone ER for a total of 6 weeks (Immediate Initiation group).
|
PALI ER Delayed Initiation
n=99 participants at risk
Subjects randomly assigned to a delayed initiation were to receive blinded resperidone at their baseline dose of 4 or 6 mg for 2 weeks and were to be initiated on blinded paliperidone ER at Day 14 for 4 weeks (Delayed Initiation group).
|
Overall
n=197 participants at risk
Combined subjects in the paliperidone ER Immediate Initiation and paliperidone ER Delayed Initiation groups.
|
|---|---|---|---|
|
Cardiac disorders
Palpitations
|
1.0%
1/98 • Number of events 2
|
0.00%
0/99
|
0.51%
1/197 • Number of events 2
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/98
|
1.0%
1/99 • Number of events 1
|
0.51%
1/197 • Number of events 1
|
|
Cardiac disorders
Tachycardia
|
2.0%
2/98 • Number of events 2
|
2.0%
2/99 • Number of events 2
|
2.0%
4/197 • Number of events 4
|
|
Endocrine disorders
Hyperprolactinaemia
|
1.0%
1/98 • Number of events 1
|
0.00%
0/99
|
0.51%
1/197 • Number of events 1
|
|
Eye disorders
Vision blurred
|
2.0%
2/98 • Number of events 2
|
0.00%
0/99
|
1.0%
2/197 • Number of events 2
|
|
Gastrointestinal disorders
Constipation
|
6.1%
6/98 • Number of events 6
|
9.1%
9/99 • Number of events 9
|
7.6%
15/197 • Number of events 15
|
|
Gastrointestinal disorders
Diarrhoea
|
2.0%
2/98 • Number of events 2
|
2.0%
2/99 • Number of events 2
|
2.0%
4/197 • Number of events 4
|
|
Gastrointestinal disorders
Dry mouth
|
1.0%
1/98 • Number of events 1
|
3.0%
3/99 • Number of events 3
|
2.0%
4/197 • Number of events 4
|
|
Gastrointestinal disorders
Dyspepsia
|
1.0%
1/98 • Number of events 1
|
0.00%
0/99
|
0.51%
1/197 • Number of events 1
|
|
Gastrointestinal disorders
Gastritis
|
1.0%
1/98 • Number of events 1
|
0.00%
0/99
|
0.51%
1/197 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
3.1%
3/98 • Number of events 4
|
5.1%
5/99 • Number of events 6
|
4.1%
8/197 • Number of events 10
|
|
Gastrointestinal disorders
Pancreatitus acute
|
1.0%
1/98 • Number of events 1
|
0.00%
0/99
|
0.51%
1/197 • Number of events 1
|
|
Gastrointestinal disorders
Salivary Hypersecretion
|
0.00%
0/98
|
1.0%
1/99 • Number of events 1
|
0.51%
1/197 • Number of events 1
|
|
Gastrointestinal disorders
Stomach discomfort
|
1.0%
1/98 • Number of events 1
|
0.00%
0/99
|
0.51%
1/197 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
2.0%
2/98 • Number of events 2
|
1.0%
1/99 • Number of events 1
|
1.5%
3/197 • Number of events 3
|
|
General disorders
Asthenia
|
1.0%
1/98 • Number of events 1
|
0.00%
0/99
|
0.51%
1/197 • Number of events 1
|
|
General disorders
Chills
|
1.0%
1/98 • Number of events 1
|
0.00%
0/99
|
0.51%
1/197 • Number of events 1
|
|
General disorders
Fatigue
|
2.0%
2/98 • Number of events 2
|
0.00%
0/99
|
1.0%
2/197 • Number of events 2
|
|
General disorders
Irritability
|
0.00%
0/98
|
1.0%
1/99 • Number of events 1
|
0.51%
1/197 • Number of events 1
|
|
Infections and infestations
Conjunctivitis viral
|
0.00%
0/98
|
1.0%
1/99 • Number of events 1
|
0.51%
1/197 • Number of events 1
|
|
Infections and infestations
Fungal infection
|
0.00%
0/98
|
1.0%
1/99 • Number of events 2
|
0.51%
1/197 • Number of events 2
|
|
Infections and infestations
Influenza
|
3.1%
3/98 • Number of events 3
|
1.0%
1/99 • Number of events 1
|
2.0%
4/197 • Number of events 4
|
|
Infections and infestations
Nasopharyngitis
|
1.0%
1/98 • Number of events 1
|
2.0%
2/99 • Number of events 3
|
1.5%
3/197 • Number of events 4
|
|
Infections and infestations
Tooth abscess
|
1.0%
1/98 • Number of events 1
|
0.00%
0/99
|
0.51%
1/197 • Number of events 1
|
|
Infections and infestations
Upper respiratory tract infection
|
1.0%
1/98 • Number of events 1
|
1.0%
1/99 • Number of events 1
|
1.0%
2/197 • Number of events 2
|
|
Injury, poisoning and procedural complications
Eye injury
|
1.0%
1/98 • Number of events 1
|
0.00%
0/99
|
0.51%
1/197 • Number of events 1
|
|
Investigations
Blood prolactin increased
|
3.1%
3/98 • Number of events 3
|
2.0%
2/99 • Number of events 2
|
2.5%
5/197 • Number of events 5
|
|
Investigations
Liver function test abnormal
|
0.00%
0/98
|
1.0%
1/99 • Number of events 1
|
0.51%
1/197 • Number of events 1
|
|
Investigations
Weight increased
|
2.0%
2/98 • Number of events 2
|
3.0%
3/99 • Number of events 3
|
2.5%
5/197 • Number of events 5
|
|
Metabolism and nutrition disorders
Anorexia
|
1.0%
1/98 • Number of events 1
|
0.00%
0/99
|
0.51%
1/197 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.0%
1/98 • Number of events 1
|
1.0%
1/99 • Number of events 1
|
1.0%
2/197 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
1.0%
1/98 • Number of events 1
|
0.00%
0/99
|
0.51%
1/197 • Number of events 1
|
|
Nervous system disorders
Akathisia
|
0.00%
0/98
|
3.0%
3/99 • Number of events 3
|
1.5%
3/197 • Number of events 3
|
|
Nervous system disorders
Balance disorder
|
1.0%
1/98 • Number of events 1
|
0.00%
0/99
|
0.51%
1/197 • Number of events 1
|
|
Nervous system disorders
Bradykinesia
|
1.0%
1/98 • Number of events 1
|
0.00%
0/99
|
0.51%
1/197 • Number of events 1
|
|
Nervous system disorders
Disturbance in attention
|
0.00%
0/98
|
1.0%
1/99 • Number of events 1
|
0.51%
1/197 • Number of events 1
|
|
Nervous system disorders
Dizziness
|
1.0%
1/98 • Number of events 1
|
5.1%
5/99 • Number of events 5
|
3.0%
6/197 • Number of events 6
|
|
Nervous system disorders
Dizziness postural
|
3.1%
3/98 • Number of events 3
|
3.0%
3/99 • Number of events 3
|
3.0%
6/197 • Number of events 6
|
|
Nervous system disorders
Dyskinesia
|
0.00%
0/98
|
3.0%
3/99 • Number of events 3
|
1.5%
3/197 • Number of events 3
|
|
Nervous system disorders
Dystonia
|
0.00%
0/98
|
2.0%
2/99 • Number of events 2
|
1.0%
2/197 • Number of events 2
|
|
Nervous system disorders
Headache
|
8.2%
8/98 • Number of events 9
|
7.1%
7/99 • Number of events 7
|
7.6%
15/197 • Number of events 16
|
|
Nervous system disorders
Hypertonia
|
1.0%
1/98 • Number of events 1
|
2.0%
2/99 • Number of events 2
|
1.5%
3/197 • Number of events 3
|
|
Nervous system disorders
Hypoaesthesia
|
1.0%
1/98 • Number of events 1
|
0.00%
0/99
|
0.51%
1/197 • Number of events 1
|
|
Nervous system disorders
Sedation
|
3.1%
3/98 • Number of events 3
|
3.0%
3/99 • Number of events 3
|
3.0%
6/197 • Number of events 6
|
|
Nervous system disorders
Somnolence
|
5.1%
5/98 • Number of events 5
|
8.1%
8/99 • Number of events 9
|
6.6%
13/197 • Number of events 14
|
|
Nervous system disorders
Tremor
|
2.0%
2/98 • Number of events 2
|
3.0%
3/99 • Number of events 4
|
2.5%
5/197 • Number of events 6
|
|
Psychiatric disorders
Abulia
|
1.0%
1/98 • Number of events 1
|
1.0%
1/99 • Number of events 1
|
1.0%
2/197 • Number of events 2
|
|
Psychiatric disorders
Agitation
|
1.0%
1/98 • Number of events 1
|
2.0%
2/99 • Number of events 5
|
1.5%
3/197 • Number of events 6
|
|
Psychiatric disorders
Anxiety
|
3.1%
3/98 • Number of events 3
|
2.0%
2/99 • Number of events 2
|
2.5%
5/197 • Number of events 5
|
|
Psychiatric disorders
Delusion
|
0.00%
0/98
|
2.0%
2/99 • Number of events 3
|
1.0%
2/197 • Number of events 3
|
|
Psychiatric disorders
Depressed mood
|
1.0%
1/98 • Number of events 1
|
0.00%
0/99
|
0.51%
1/197 • Number of events 1
|
|
Psychiatric disorders
Depression
|
0.00%
0/98
|
1.0%
1/99 • Number of events 1
|
0.51%
1/197 • Number of events 1
|
|
Psychiatric disorders
Hallucination
|
0.00%
0/98
|
2.0%
2/99 • Number of events 2
|
1.0%
2/197 • Number of events 2
|
|
Psychiatric disorders
Insomnia
|
9.2%
9/98 • Number of events 10
|
9.1%
9/99 • Number of events 10
|
9.1%
18/197 • Number of events 20
|
|
Psychiatric disorders
Libido decreased
|
2.0%
2/98 • Number of events 2
|
3.0%
3/99 • Number of events 3
|
2.5%
5/197 • Number of events 5
|
|
Psychiatric disorders
Libido increased
|
0.00%
0/98
|
1.0%
1/99 • Number of events 1
|
0.51%
1/197 • Number of events 1
|
|
Psychiatric disorders
Mood altered
|
1.0%
1/98 • Number of events 1
|
0.00%
0/99
|
0.51%
1/197 • Number of events 1
|
|
Psychiatric disorders
Paranoia
|
1.0%
1/98 • Number of events 1
|
0.00%
0/99
|
0.51%
1/197 • Number of events 1
|
|
Psychiatric disorders
Psychotic disorder
|
1.0%
1/98 • Number of events 1
|
1.0%
1/99 • Number of events 1
|
1.0%
2/197 • Number of events 2
|
|
Psychiatric disorders
Restlessness
|
1.0%
1/98 • Number of events 1
|
0.00%
0/99
|
0.51%
1/197 • Number of events 1
|
|
Psychiatric disorders
Schizophrenia
|
2.0%
2/98 • Number of events 3
|
4.0%
4/99 • Number of events 7
|
3.0%
6/197 • Number of events 10
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/98
|
2.0%
2/99 • Number of events 2
|
1.0%
2/197 • Number of events 2
|
|
Reproductive system and breast disorders
Amenorrhoea
|
1.0%
1/98 • Number of events 1
|
0.00%
0/99
|
0.51%
1/197 • Number of events 1
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
1.0%
1/98 • Number of events 1
|
2.0%
2/99 • Number of events 2
|
1.5%
3/197 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Galactorrhoea
|
1.0%
1/98 • Number of events 2
|
0.00%
0/99
|
0.51%
1/197 • Number of events 2
|
|
Reproductive system and breast disorders
Menorrhagia
|
1.0%
1/98 • Number of events 1
|
0.00%
0/99
|
0.51%
1/197 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
1.0%
1/98 • Number of events 1
|
0.00%
0/99
|
0.51%
1/197 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.0%
2/98 • Number of events 2
|
0.00%
0/99
|
1.0%
2/197 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Dry throat
|
2.0%
2/98 • Number of events 2
|
0.00%
0/99
|
1.0%
2/197 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
1.0%
1/98 • Number of events 1
|
0.00%
0/99
|
0.51%
1/197 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
1.0%
1/98 • Number of events 1
|
0.00%
0/99
|
0.51%
1/197 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
1.0%
1/98 • Number of events 1
|
2.0%
2/99 • Number of events 2
|
1.5%
3/197 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
2.0%
2/98 • Number of events 2
|
0.00%
0/99
|
1.0%
2/197 • Number of events 2
|
Additional Information
Vice President, Medical Affairs, CNS
Ortho McNeil Janssen Scientific Affairs, LLC
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60