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Study to Measure Drug Satisfaction of Patients With Schizophrenia After Switching From Risperidone to Paliperidone

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00535132
Recruitment Status : Completed
First Posted : September 26, 2007
Results First Posted : October 20, 2009
Last Update Posted : May 9, 2014
Sponsor:
Information provided by (Responsible Party):
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Schizophrenia
Interventions Drug: Oral Risperidone
Drug: Paliperidone ER
Enrollment 201
Recruitment Details  
Pre-assignment Details  
Arm/Group Title PALI ER Immediate Initiation PALI ER Delayed Initiation
Hide Arm/Group Description 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). 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).
Period Title: Randomized Population
Started 100 [1] 101 [1]
Completed 100 101
Not Completed 0 0
[1]
Number of Subjects Randomized
Period Title: Safety Analysis Set
Started 100 101
Completed 98 [1] 99 [1]
Not Completed 2 2
Reason Not Completed
Did Not Receive Study Medication             2             2
[1]
Two patients were randomized but not treated.
Period Title: Intent-to-Treat (ITT) Analysis Set
Started 98 99
Completed 95 [1] 96 [1]
Not Completed 3 3
Reason Not Completed
No Follow-up Efficacy Data             3             3
[1]
Patients who received at least one dose of study drug and have some follow-up efficacy data.
Arm/Group Title PALI ER Immediate Initiation PALI ER Delayed Initiation Total
Hide Arm/Group Description 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). 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 of all reporting groups
Overall Number of Baseline Participants 98 99 197
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 98 participants 99 participants 197 participants
41.1  (12.5) 40.2  (11.4) 40.6  (11.9)
[1]
Measure Description: Safety Analysis Set.
Sex/Gender, Customized   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 98 participants 99 participants 197 participants
Male 58 53 111
Female 40 46 86
[1]
Measure Description: Safety Analysis Set.
Race (NIH/OMB)   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 98 participants 99 participants 197 participants
American Indian or Alaska Native
2
   2.0%
0
   0.0%
2
   1.0%
Asian
0
   0.0%
1
   1.0%
1
   0.5%
Native Hawaiian or Other Pacific Islander
1
   1.0%
0
   0.0%
1
   0.5%
Black or African American
31
  31.6%
26
  26.3%
57
  28.9%
White
61
  62.2%
69
  69.7%
130
  66.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
3
   3.1%
3
   3.0%
6
   3.0%
[1]
Measure Description: Safety Analysis Set.
1.Primary Outcome
Title Medication Satisfaction Questionnaire (MSQ) Score Change From Baseline to the Week 6 Endpoint.
Hide Description 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).
Time Frame Change from Baseline in MSQ Score at Week 6 Last Observation Carried Forward (LOCF)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat Population with non-missing values at this timepoint
Arm/Group Title PALI ER Immediate Initiation PALI ER Delayed Initiation Overall
Hide Arm/Group Description:
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).
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).
Combined subjects in the paliperidone ER Immediate Initiation and paliperidone ER Delayed Initiation groups.
Overall Number of Participants Analyzed 95 96 191
Mean (Standard Deviation)
Unit of Measure: Points on a scale
2.5  (1.2) 2.3  (1.5) 2.4  (1.4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Overall
Comments Sample size for this study was based on changes in the MSQ scores within subjects from baseline to endpoint using a one-sample paired t-test. A sample size of 97 subjects was shown to have 90% power at endpoint to detect a mean change from baseline of 0.5 units on the MSQ score, with a standard deviation of 1.5. Allowing for extra variability from subjects with prior generic risperidone (instead of branded risperidone) use, this number was increased to 150 subjects.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments p-value based on a paired t-test for a within-group comparison.
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 2.4
Parameter Dispersion
Type: Standard Deviation
Value: 1.4
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Medication Satisfaction Questionnaire (MSQ) Score Change From Baseline to Week 2 (Observed).
Hide Description 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).
Time Frame Change from Baseline in MSQ Score at Week 2
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat Population with non-missing values at this timepoint
Arm/Group Title PALI ER Immediate Initiation PALI ER Delayed Initiation Overall
Hide Arm/Group Description:
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).
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).
Combined subjects in the paliperidone ER Immediate Initiation and paliperidone ER Delayed Initiation groups.
Overall Number of Participants Analyzed 93 95 188
Mean (Standard Deviation)
Unit of Measure: Points on a scale
2.0  (1.4) 1.6  (1.4) 1.8  (1.4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Overall
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method t-test, 2 sided
Comments p-value for within-group comparison based on a paired t-test.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 1.8
Parameter Dispersion
Type: Standard Deviation
Value: 1.4
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Medication Satisfaction Questionnaire (MSQ) Score Change From Baseline to Week 4 (Observed).
Hide Description 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).
Time Frame Change from Baseline in MSQ Score at Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat Population with non-missing values at this timepoint
Arm/Group Title PALI ER Immediate Initiation PALI ER Delayed Initiation Overall
Hide Arm/Group Description:
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).
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).
Combined subjects in the paliperidone ER Immediate Initiation and paliperidone ER Delayed Initiation groups.
Overall Number of Participants Analyzed 89 91 180
Mean (Standard Deviation)
Unit of Measure: Points on a scale
2.4  (1.2) 2.1  (1.5) 2.3  (1.4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Overall
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 2.3
Parameter Dispersion
Type: Standard Deviation
Value: 1.4
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Medication Satisfaction Questionnaire (MSQ) Score Change From Baseline to Week 6 (Observed).
Hide Description 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).
Time Frame Change from Baseline in MSQ Score at Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat Population with non-missing values at this timepoint
Arm/Group Title PALI ER Immediate Initiation PALI ER Delayed Initiation Overall
Hide Arm/Group Description:
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).
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).
Combined subjects in the paliperidone ER Immediate Initiation and paliperidone ER Delayed Initiation groups.
Overall Number of Participants Analyzed 85 87 172
Mean (Standard Deviation)
Unit of Measure: Points on a scale
2.5  (1.2) 2.4  (1.3) 2.5  (1.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Overall
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method t-test, 2 sided
Comments p-value for within-group comparison based on a paired t-test.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 2.5
Parameter Dispersion
Type: Standard Deviation
Value: 1.3
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Medication Satisfaction Questionnaire (MSQ) - Categorical Summary - Dichotomized Categories - Week 2 (Observed).
Hide Description 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).
Time Frame Week 2
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat Population with non-missing values at this timepoint
Arm/Group Title PALI ER Immediate Initiation PALI ER Delayed Initiation Overall
Hide Arm/Group Description:
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).
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).
Combined subjects in the paliperidone ER Immediate Initiation and paliperidone ER Delayed Initiation groups.
Overall Number of Participants Analyzed 93 95 188
Measure Type: Number
Unit of Measure: Participants
Satisfied (score 5-7) 63 43 106
Dissatisfied (score 1-4) 30 52 82
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Overall
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments [Not Specified]
Method Fisher Exact
Comments P-values for the study group comparisons using dichotomized categories are based on Fisher's Exact Test.
6.Secondary Outcome
Title Medication Satisfaction Questionnaire (MSQ) - Categorical Summary - Dichotomized Categories - Week 4 (Observed).
Hide Description 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).
Time Frame Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat Population with non-missing values at this timepoint
Arm/Group Title PALI ER Immediate Initiation PALI ER Delayed Initiation Overall
Hide Arm/Group Description:
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).
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).
Combined subjects in the paliperidone ER Immediate Initiation and paliperidone ER Delayed Initiation groups.
Overall Number of Participants Analyzed 89 91 180
Measure Type: Number
Unit of Measure: Participants
Satisfied (score 5-7) 75 64 139
Dissatisfied (score 1-4) 14 27 41
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Overall
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.033
Comments [Not Specified]
Method Fisher Exact
Comments P-values for the study group comparisons using dichotomized categories are based on Fisher's Exact Test.
7.Secondary Outcome
Title Medication Satisfaction Questionnaire (MSQ) - Categorical Summary - Dichotomized Categories - Week 6 (Observed).
Hide Description 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).
Time Frame Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat Population with non-missing values at this timepoint
Arm/Group Title PALI ER Immediate Initiation PALI ER Delayed Initiation Overall
Hide Arm/Group Description:
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).
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).
Combined subjects in the paliperidone ER Immediate Initiation and paliperidone ER Delayed Initiation groups.
Overall Number of Participants Analyzed 85 87 172
Measure Type: Number
Unit of Measure: Participants
Satisfied (score 5-7) 77 71 148
Dissatisfied (score 1-4) 8 16 24
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Overall
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.123
Comments P-values for the study group comparisons using dichotomized categories are based on Fisher's Exact Test.
Method Fisher Exact
Comments [Not Specified]
8.Secondary Outcome
Title Medication Satisfaction Questionnaire (MSQ) - Categorical Summary - Dichotomized Categories - Week 6 LOCF.
Hide Description 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).
Time Frame Week 6 LOCF
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat Population with non-missing values at this timepoint
Arm/Group Title PALI ER Immediate Initiation PALI ER Delayed Initiation Overall
Hide Arm/Group Description:
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).
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).
Combined subjects in the paliperidone ER Immediate Initiation and paliperidone ER Delayed Initiation groups.
Overall Number of Participants Analyzed 95 96 191
Measure Type: Number
Unit of Measure: Participants
Satisfied (score 5-7) 83 75 158
Dissatisfied (score 1-4) 12 21 33
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Overall
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.125
Comments [Not Specified]
Method Fisher Exact
Comments P-values for the study group comparisons using dichotomized categories are based on Fisher's Exact Test.
9.Secondary Outcome
Title Treatment Satisfaction Questionnaire for Medication (TSQM) Global Satisfaction Score Change From Baseline to the Week 6 Endpoint
Hide Description 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.
Time Frame Change from Baseline to Week 6 LOCF
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat Population with non-missing values at this timepoint
Arm/Group Title PALI ER Immediate Initiation PALI ER Delayed Initiation Overall
Hide Arm/Group Description:
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).
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).
Combined subjects in the paliperidone ER Immediate Initiation and paliperidone ER Delayed Initiation groups.
Overall Number of Participants Analyzed 95 96 191
Mean (Standard Deviation)
Unit of Measure: Points on a scale
30.2  (22.6) 26.4  (23.6) 28.3  (23.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Overall
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments p-value for within-group comparison based on a paired t-test.
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 28.3
Parameter Dispersion
Type: Standard Deviation
Value: 23.1
Estimation Comments [Not Specified]
10.Secondary Outcome
Title Short Form-36 Health Survey (SF-36) Physical Health Composite Score Change From Baseline to the Week 6 Endpoint
Hide Description 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.
Time Frame Change from Baseline to Week 6 LOCF
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat Population with non-missing values at this timepoint
Arm/Group Title PALI ER Immediate Initiation PALI ER Delayed Initiation Overall
Hide Arm/Group Description:
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).
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).
Combined subjects in the paliperidone ER Immediate Initiation and paliperidone ER Delayed Initiation groups.
Overall Number of Participants Analyzed 88 91 179
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
0.8  (8.4) 2.1  (6.4) 1.5  (7.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Overall
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.009
Comments [Not Specified]
Method t-test, 2 sided
Comments p-value for within-group comparison based on a paired t-test.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 1.5
Parameter Dispersion
Type: Standard Deviation
Value: 7.5
Estimation Comments [Not Specified]
11.Secondary Outcome
Title Short Form-36 Health Survey (SF-36) Mental Health Composite Score Change From Baseline to the Week 6 Endpoint
Hide Description 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.
Time Frame Change from Baseline to Week 6 LOCF
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat Population with non-missing values at this timepoint
Arm/Group Title PALI ER Immediate Initiation PALI ER Delayed Initiation Overall
Hide Arm/Group Description:
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).
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).
Combined subjects in the paliperidone ER Immediate Initiation and paliperidone ER Delayed Initiation groups.
Overall Number of Participants Analyzed 88 91 179
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
6.7  (10.3) 7.2  (10.6) 7.0  (10.4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Overall
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method t-test, 2 sided
Comments p-value for within-group comparison based on a paired t-test.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 7.0
Parameter Dispersion
Type: Standard Deviation
Value: 10.4
Estimation Comments [Not Specified]
12.Secondary Outcome
Title Pittsburgh Sleep Quality Index (PSQI) Change From Baseline to the Week 6 Endpoint
Hide Description 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.
Time Frame Change from Baseline to Week 6 LOCF
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat Population with non-missing values at this timepoint
Arm/Group Title PALI ER Immediate Initiation PALI ER Delayed Initiation Overall
Hide Arm/Group Description:
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).
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).
Combined subjects in the paliperidone ER Immediate Initiation and paliperidone ER Delayed Initiation groups.
Overall Number of Participants Analyzed 84 84 168
Mean (Standard Deviation)
Unit of Measure: Points on a scale
-2.3  (4.3) -2.2  (4.4) -2.3  (4.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Overall
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method t-test, 2 sided
Comments p-value for within-group comparison based on a paired t-test.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -2.3
Parameter Dispersion
Type: Standard Deviation
Value: 4.3
Estimation Comments [Not Specified]
13.Secondary Outcome
Title Modified COVI Anxiety Scale (m-COVI) Change From Baseline to the Week 6 Endpoint
Hide Description 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.
Time Frame Change from Baseline to Week 6 LOCF
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat Population with non-missing values at this timepoint
Arm/Group Title PALI ER Immediate Initiation PALI ER Delayed Initiation Overall
Hide Arm/Group Description:
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).
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).
Combined subjects in the paliperidone ER Immediate Initiation and paliperidone ER Delayed Initiation groups.
Overall Number of Participants Analyzed 88 80 168
Mean (Standard Deviation)
Unit of Measure: Points on a scale
-1.4  (2.8) -1.3  (3.2) -1.3  (3.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Overall
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method t-test, 2 sided
Comments p-value for within-group comparison based on a paired t-test.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.3
Parameter Dispersion
Type: Standard Deviation
Value: 3.0
Estimation Comments [Not Specified]
14.Other Pre-specified Outcome
Title Positive and Negative Syndrome Scale (PANSS) Total Score Change From Baseline to Week 6 Endpoint
Hide Description 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.
Time Frame Change from Baseline to Week 6 LOCF
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat Population with non-missing values at this timepoint
Arm/Group Title PALI ER Immediate Initiation PALI ER Delayed Initiation Overall
Hide Arm/Group Description:
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).
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).
Combined subjects in the paliperidone ER Immediate Initiation and paliperidone ER Delayed Initiation groups.
Overall Number of Participants Analyzed 95 96 191
Mean (Standard Deviation)
Unit of Measure: Points on a scale
-13.5  (12.2) -12.3  (14.0) -12.9  (13.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Overall
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method t-test, 2 sided
Comments p-value for within-group comparison based on a paired t-test.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -12.9
Parameter Dispersion
Type: Standard Deviation
Value: 13.1
Estimation Comments [Not Specified]
15.Other Pre-specified Outcome
Title Clinical Global Impression - Severity (CGI-S) Change From Baseline to Week 6 Endpoint
Hide 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 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.
Time Frame Change from Baseline to Week 6 LOCF
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat Population with non-missing values at this timepoint
Arm/Group Title PALI ER Immediate Initiation PALI ER Delayed Initiation Overall
Hide Arm/Group Description:
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).
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).
Combined subjects in the paliperidone ER Immediate Initiation and paliperidone ER Delayed Initiation groups.
Overall Number of Participants Analyzed 95 96 191
Mean (Standard Deviation)
Unit of Measure: Points on a scale
-0.8  (0.9) -0.8  (1.0) -0.8  (0.9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Overall
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method t-test, 2 sided
Comments p-value for within-group comparison based on a paired t-test.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.8
Parameter Dispersion
Type: Standard Deviation
Value: 0.9
Estimation Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title PALI ER Immediate Initiation PALI ER Delayed Initiation Overall
Hide Arm/Group Description 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). 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). Combined subjects in the paliperidone ER Immediate Initiation and paliperidone ER Delayed Initiation groups.
All-Cause Mortality
PALI ER Immediate Initiation PALI ER Delayed Initiation Overall
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
PALI ER Immediate Initiation PALI ER Delayed Initiation Overall
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/98 (3.06%)      4/99 (4.04%)      7/197 (3.55%)    
Gastrointestinal disorders       
Pancreatitis acute  1  1/98 (1.02%)  0/99 (0.00%)  1/197 (0.51%) 
Psychiatric disorders       
Schizophrenia  1  2/98 (2.04%)  4/99 (4.04%)  6/197 (3.05%) 
Respiratory, thoracic and mediastinal disorders       
Chronic obstructive pulmonary disease  1  1/98 (1.02%)  0/99 (0.00%)  1/197 (0.51%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 9.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
PALI ER Immediate Initiation PALI ER Delayed Initiation Overall
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   49/98 (50.00%)      56/99 (56.57%)      105/197 (53.30%)    
Cardiac disorders       
Palpitations  1  1/98 (1.02%)  2 0/99 (0.00%)  0 1/197 (0.51%)  2
Sinus bradycardia  1  0/98 (0.00%)  0 1/99 (1.01%)  1 1/197 (0.51%)  1
Tachycardia  1  2/98 (2.04%)  2 2/99 (2.02%)  2 4/197 (2.03%)  4
Endocrine disorders       
Hyperprolactinaemia  1  1/98 (1.02%)  1 0/99 (0.00%)  0 1/197 (0.51%)  1
Eye disorders       
Vision blurred  1  2/98 (2.04%)  2 0/99 (0.00%)  0 2/197 (1.02%)  2
Gastrointestinal disorders       
Constipation  1  6/98 (6.12%)  6 9/99 (9.09%)  9 15/197 (7.61%)  15
Diarrhoea  1  2/98 (2.04%)  2 2/99 (2.02%)  2 4/197 (2.03%)  4
Dry mouth  1  1/98 (1.02%)  1 3/99 (3.03%)  3 4/197 (2.03%)  4
Dyspepsia  1  1/98 (1.02%)  1 0/99 (0.00%)  0 1/197 (0.51%)  1
Gastritis  1  1/98 (1.02%)  1 0/99 (0.00%)  0 1/197 (0.51%)  1
Nausea  1  3/98 (3.06%)  4 5/99 (5.05%)  6 8/197 (4.06%)  10
Pancreatitus acute  1  1/98 (1.02%)  1 0/99 (0.00%)  0 1/197 (0.51%)  1
Salivary Hypersecretion  1  0/98 (0.00%)  0 1/99 (1.01%)  1 1/197 (0.51%)  1
Stomach discomfort  1  1/98 (1.02%)  1 0/99 (0.00%)  0 1/197 (0.51%)  1
Vomiting  1  2/98 (2.04%)  2 1/99 (1.01%)  1 3/197 (1.52%)  3
General disorders       
Asthenia  1  1/98 (1.02%)  1 0/99 (0.00%)  0 1/197 (0.51%)  1
Chills  1  1/98 (1.02%)  1 0/99 (0.00%)  0 1/197 (0.51%)  1
Fatigue  1  2/98 (2.04%)  2 0/99 (0.00%)  0 2/197 (1.02%)  2
Irritability  1  0/98 (0.00%)  0 1/99 (1.01%)  1 1/197 (0.51%)  1
Infections and infestations       
Conjunctivitis viral  1  0/98 (0.00%)  0 1/99 (1.01%)  1 1/197 (0.51%)  1
Fungal infection  1  0/98 (0.00%)  0 1/99 (1.01%)  2 1/197 (0.51%)  2
Influenza  1  3/98 (3.06%)  3 1/99 (1.01%)  1 4/197 (2.03%)  4
Nasopharyngitis  1  1/98 (1.02%)  1 2/99 (2.02%)  3 3/197 (1.52%)  4
Tooth abscess  1  1/98 (1.02%)  1 0/99 (0.00%)  0 1/197 (0.51%)  1
Upper respiratory tract infection  1  1/98 (1.02%)  1 1/99 (1.01%)  1 2/197 (1.02%)  2
Injury, poisoning and procedural complications       
Eye injury  1  1/98 (1.02%)  1 0/99 (0.00%)  0 1/197 (0.51%)  1
Investigations       
Blood prolactin increased  1  3/98 (3.06%)  3 2/99 (2.02%)  2 5/197 (2.54%)  5
Liver function test abnormal  1  0/98 (0.00%)  0 1/99 (1.01%)  1 1/197 (0.51%)  1
Weight increased  1  2/98 (2.04%)  2 3/99 (3.03%)  3 5/197 (2.54%)  5
Metabolism and nutrition disorders       
Anorexia  1  1/98 (1.02%)  1 0/99 (0.00%)  0 1/197 (0.51%)  1
Musculoskeletal and connective tissue disorders       
Back pain  1  1/98 (1.02%)  1 1/99 (1.01%)  1 2/197 (1.02%)  2
Myalgia  1  1/98 (1.02%)  1 0/99 (0.00%)  0 1/197 (0.51%)  1
Nervous system disorders       
Akathisia  1  0/98 (0.00%)  0 3/99 (3.03%)  3 3/197 (1.52%)  3
Balance disorder  1  1/98 (1.02%)  1 0/99 (0.00%)  0 1/197 (0.51%)  1
Bradykinesia  1  1/98 (1.02%)  1 0/99 (0.00%)  0 1/197 (0.51%)  1
Disturbance in attention  1  0/98 (0.00%)  0 1/99 (1.01%)  1 1/197 (0.51%)  1
Dizziness  1  1/98 (1.02%)  1 5/99 (5.05%)  5 6/197 (3.05%)  6
Dizziness postural  1  3/98 (3.06%)  3 3/99 (3.03%)  3 6/197 (3.05%)  6
Dyskinesia  1  0/98 (0.00%)  0 3/99 (3.03%)  3 3/197 (1.52%)  3
Dystonia  1  0/98 (0.00%)  0 2/99 (2.02%)  2 2/197 (1.02%)  2
Headache  1  8/98 (8.16%)  9 7/99 (7.07%)  7 15/197 (7.61%)  16
Hypertonia  1  1/98 (1.02%)  1 2/99 (2.02%)  2 3/197 (1.52%)  3
Hypoaesthesia  1  1/98 (1.02%)  1 0/99 (0.00%)  0 1/197 (0.51%)  1
Sedation  1  3/98 (3.06%)  3 3/99 (3.03%)  3 6/197 (3.05%)  6
Somnolence  1  5/98 (5.10%)  5 8/99 (8.08%)  9 13/197 (6.60%)  14
Tremor  1  2/98 (2.04%)  2 3/99 (3.03%)  4 5/197 (2.54%)  6
Psychiatric disorders       
Abulia  1  1/98 (1.02%)  1 1/99 (1.01%)  1 2/197 (1.02%)  2
Agitation  1  1/98 (1.02%)  1 2/99 (2.02%)  5 3/197 (1.52%)  6
Anxiety  1  3/98 (3.06%)  3 2/99 (2.02%)  2 5/197 (2.54%)  5
Delusion  1  0/98 (0.00%)  0 2/99 (2.02%)  3 2/197 (1.02%)  3
Depressed mood  1  1/98 (1.02%)  1 0/99 (0.00%)  0 1/197 (0.51%)  1
Depression  1  0/98 (0.00%)  0 1/99 (1.01%)  1 1/197 (0.51%)  1
Hallucination  1  0/98 (0.00%)  0 2/99 (2.02%)  2 2/197 (1.02%)  2
Insomnia  1  9/98 (9.18%)  10 9/99 (9.09%)  10 18/197 (9.14%)  20
Libido decreased  1  2/98 (2.04%)  2 3/99 (3.03%)  3 5/197 (2.54%)  5
Libido increased  1  0/98 (0.00%)  0 1/99 (1.01%)  1 1/197 (0.51%)  1
Mood altered  1  1/98 (1.02%)  1 0/99 (0.00%)  0 1/197 (0.51%)  1
Paranoia  1  1/98 (1.02%)  1 0/99 (0.00%)  0 1/197 (0.51%)  1
Psychotic disorder  1  1/98 (1.02%)  1 1/99 (1.01%)  1 2/197 (1.02%)  2
Restlessness  1  1/98 (1.02%)  1 0/99 (0.00%)  0 1/197 (0.51%)  1
Schizophrenia  1  2/98 (2.04%)  3 4/99 (4.04%)  7 6/197 (3.05%)  10
Suicidal ideation  1  0/98 (0.00%)  0 2/99 (2.02%)  2 2/197 (1.02%)  2
Reproductive system and breast disorders       
Amenorrhoea  1  1/98 (1.02%)  1 0/99 (0.00%)  0 1/197 (0.51%)  1
Erectile dysfunction  1  1/98 (1.02%)  1 2/99 (2.02%)  2 3/197 (1.52%)  3
Menorrhagia  1  1/98 (1.02%)  1 0/99 (0.00%)  0 1/197 (0.51%)  1
Respiratory, thoracic and mediastinal disorders       
Galactorrhoea  1  1/98 (1.02%)  2 0/99 (0.00%)  0 1/197 (0.51%)  2
Chronic obstructive pulmonary disease  1  1/98 (1.02%)  1 0/99 (0.00%)  0 1/197 (0.51%)  1
Cough  1  2/98 (2.04%)  2 0/99 (0.00%)  0 2/197 (1.02%)  2
Dry throat  1  2/98 (2.04%)  2 0/99 (0.00%)  0 2/197 (1.02%)  2
Dysphonia  1  1/98 (1.02%)  1 0/99 (0.00%)  0 1/197 (0.51%)  1
Nasal congestion  1  1/98 (1.02%)  1 0/99 (0.00%)  0 1/197 (0.51%)  1
Pharyngolaryngeal pain  1  1/98 (1.02%)  1 2/99 (2.02%)  2 3/197 (1.52%)  3
Rhinorrhoea  1  2/98 (2.04%)  2 0/99 (0.00%)  0 2/197 (1.02%)  2
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 9.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Vice President, Medical Affairs, CNS
Organization: Ortho McNeil Janssen Scientific Affairs, LLC
Phone: 609-730-2136
Responsible Party: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier: NCT00535132     History of Changes
Other Study ID Numbers: CR014347
R076477SCH4013
First Submitted: September 24, 2007
First Posted: September 26, 2007
Results First Submitted: July 17, 2009
Results First Posted: October 20, 2009
Last Update Posted: May 9, 2014