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Effectiveness and Safety of 3 Fixed Doses (25 mg eq., 100 mg eq., and 150 mg eq.) of Paliperidone Palmitate in Patients With Schizophrenia

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ClinicalTrials.gov Identifier: NCT00590577
Recruitment Status : Completed
First Posted : January 10, 2008
Results First Posted : October 5, 2009
Last Update Posted : June 4, 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: Paliperidone palmitate 25 mg eq.
Drug: Paliperidone palmitate 150 mg eq.
Drug: Placebo
Drug: Paliperidone palmitate 100 mg eq.
Enrollment 652
Recruitment Details The recruitment period was 8 March 2007 (first patient enrolled) to 24 March 2008 (last patient left the study). The study was performed in medical clinics located around the world.
Pre-assignment Details Before assignment to treatment groups, patients stopped taking disallowed medications. At the same time, patients who had not previously taken paliperidone extended release (ER) or risperidone or had previously taken it but were not currently taking another antipsychotic took paliperidone ER 6 mg/day for 4 to 6 days to assess tolerance to the drug.
Arm/Group Title Paliperidone Palmitate 25 mg eq. Paliperidone Palmitate 100 mg eq. Paliperidone Palmitate 150 mg eq. Placebo
Hide Arm/Group Description Paliperidone palmitate 150 mg eq. (i.m., deltoid muscle) on Day 1, and 25 mg eq. (i.m., gluteal or deltoid muscle, left or right side, at the discretion of the investigator) on Days 8, 36, and 64. Paliperidone palmitate 150 mg eq. (i.m., deltoid muscle) on Day 1, and 100 mg eq. (i.m., gluteal or deltoid muscle, left or right side, at the discretion of the investigator) on Days 8, 36, and 64. Paliperidone palmitate 150 mg eq. on Day 1 (i.m., deltoid muscle) and on Days 8, 36, and 64 (i.m., gluteal or deltoid muscle, left or right side, at the discretion of the investigator). Placebo on Day 1 (i.m., deltoid muscle) and Days 8, 36, and 64 (i.m., gluteal or deltoid muscle, left or right side, at the discretion of the investigator).
Period Title: Overall Study
Started 160 165 163 164
Completed 83 89 90 71
Not Completed 77 76 73 93
Reason Not Completed
Lack of Efficacy             31             28             23             45
Withdrawal by Subject             23             28             30             26
Adverse Event             10             10             13             11
Lost to Follow-up             12             6             6             9
Pregnancy             0             1             0             0
Various reasons             1             3             1             2
Arm/Group Title Paliperidone Palmitate 25 mg eq. Paliperidone Palmitate 100 mg eq. Paliperidone Palmitate 150 mg eq. Placebo Total
Hide Arm/Group Description Paliperidone palmitate 150 mg eq. (i.m., deltoid muscle) on Day 1, and 25 mg eq. (i.m., gluteal or deltoid muscle, left or right side, at the discretion of the investigator) on Days 8, 36, and 64. Paliperidone palmitate 150 mg eq. (i.m., deltoid muscle) on Day 1, and 100 mg eq. (i.m., gluteal or deltoid muscle, left or right side, at the discretion of the investigator) on Days 8, 36, and 64. Paliperidone palmitate 150 mg eq. on Day 1 (i.m., deltoid muscle) and on Days 8, 36, and 64 (i.m., gluteal or deltoid muscle, left or right side, at the discretion of the investigator). Placebo on Day 1 (i.m., deltoid muscle) and Days 8, 36, and 64 (i.m., gluteal or deltoid muscle, left or right side, at the discretion of the investigator). Total of all reporting groups
Overall Number of Baseline Participants 160 165 163 164 652
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 160 participants 165 participants 163 participants 164 participants 652 participants
<=18 years
0
   0.0%
1
   0.6%
1
   0.6%
0
   0.0%
2
   0.3%
Between 18 and 65 years
160
 100.0%
163
  98.8%
160
  98.2%
163
  99.4%
646
  99.1%
>=65 years
0
   0.0%
1
   0.6%
2
   1.2%
1
   0.6%
4
   0.6%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 160 participants 165 participants 163 participants 164 participants 652 participants
39.2  (10.33) 38.7  (10.27) 39.4  (10.69) 39.9  (10.96) 39.3  (10.55)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 160 participants 165 participants 163 participants 164 participants 652 participants
Female
44
  27.5%
55
  33.3%
58
  35.6%
55
  33.5%
212
  32.5%
Male
116
  72.5%
110
  66.7%
105
  64.4%
109
  66.5%
440
  67.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 160 participants 165 participants 163 participants 164 participants 652 participants
United States 78 82 85 84 329
Russian Federation 32 33 33 32 130
Ukraine 13 14 13 13 53
Romania 11 10 8 10 39
Taiwan 10 10 9 10 39
Malaysia 7 8 7 7 29
Korea, Republic of 7 5 6 6 24
Serbia 2 3 2 2 9
1.Primary Outcome
Title Change in Positive and Negative Syndrome Scale (PANSS) Total Score From Baseline to Week 13 or the Last Post-baseline Assessment
Hide Description The PANSS measures the severity of psychotic symptoms of schizophrenia. Scores range from 30 to 210, where 30=best and 210=worst. The change in PANSS total score for all eligible subjects was measured from the beginning of the study to Week 13 (i.e., the end of the double-blind treatment period) or, if the subject left the study early, from the beginning of the study to the last assessment after baseline.
Time Frame Baseline to 13 weeks or the last post-baseline assessment
Hide Outcome Measure Data
Hide Analysis Population Description
The primary outcome measure used the intent-to-treat analysis set, which consisted of all enrolled subjects who got at least 1 dose of paliperidone palmitate and had both a baseline and at least 1 post-baseline efficacy measurement during the study. For imputation of missing time points, last observation carried forward (LOCF) was used.
Arm/Group Title Paliperidone Palmitate 25 mg eq. Paliperidone Palmitate 100 mg eq. Paliperidone Palmitate 150 mg eq. Placebo
Hide Arm/Group Description:
Paliperidone palmitate 150 mg eq. (i.m., deltoid muscle) on Day 1, and 25 mg eq. (i.m., gluteal or deltoid muscle, left or right side, at the discretion of the investigator) on Days 8, 36, and 64.
Paliperidone palmitate 150 mg eq. (i.m., deltoid muscle) on Day 1, and 100 mg eq. (i.m., gluteal or deltoid muscle, left or right side, at the discretion of the investigator) on Days 8, 36, and 64.
Paliperidone palmitate 150 mg eq. on Day 1 (i.m., deltoid muscle) and on Days 8, 36, and 64 (i.m., gluteal or deltoid muscle, left or right side, at the discretion of the investigator).
Placebo on Day 1 (i.m., deltoid muscle) and Days 8, 36, and 64 (i.m., gluteal or deltoid muscle, left or right side, at the discretion of the investigator).
Overall Number of Participants Analyzed 155 161 160 160
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
-8.0  (19.90) -11.6  (17.63) -13.2  (18.48) -2.9  (19.26)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Paliperidone Palmitate 150 mg eq., Placebo
Comments The overall type I error rate for testing all paliperidone palmitate doses vs. placebo for both the primary outcome and key secondary outcome was controlled at the 2-sided 0.05 significance level. The 2 families of hypotheses (in each family, comparison of each paliperidone palmitate dose vs. placebo) were tested using a parallel gatekeeping procedure that adjusts for multiplicity by using Dunnett’s method in each family of hypotheses and using Bonferroni’s inequality between different families.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Used analysis of covariance model with treatment (placebo, paliperidone palmitate 25, 100, 150 mg eq.) and country as factors and baseline value as a covariate. P-values adjusted for multiplicity for comparison with placebo using Dunnett's test.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in least-squares means
Estimated Value -9.8
Confidence Interval 95%
-13.71 to -5.85
Parameter Dispersion
Type: Standard Error of the mean
Value: 2.00
Estimation Comments The 95% confidence intervals were unadjusted for multiplicity.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Paliperidone Palmitate 100 mg eq., Placebo
Comments The overall type I error rate for testing all paliperidone palmitate doses vs. placebo for both the primary outcome and key secondary outcome was controlled at the 2-sided 0.05 significance level. The 2 families of hypotheses (in each family, comparison of each paliperidone palmitate dose vs. placebo) were tested using a parallel gatekeeping procedure that adjusts for multiplicity by using Dunnett’s method in each family of hypotheses and using Bonferroni’s inequality between different families.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Used analysis of covariance model with treatment (placebo, paliperidone palmitate 25, 100, 150 mg eq.) and country as factors and baseline value as a covariate. P-values adjusted for multiplicity for comparison with placebo using Dunnett's test.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in least-squares means
Estimated Value -8.7
Confidence Interval 95%
-12.62 to -4.78
Parameter Dispersion
Type: Standard Error of the mean
Value: 2.00
Estimation Comments The 95% confidence intervals were unadjusted for multiplicity.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Paliperidone Palmitate 25 mg eq., Placebo
Comments The overall type I error rate for testing all paliperidone palmitate doses vs. placebo for both the primary outcome and key secondary outcome was controlled at the 2-sided 0.05 significance level. The 2 families of hypotheses (in each family, comparison of each paliperidone palmitate dose vs. placebo) were tested using a parallel gatekeeping procedure that adjusts for multiplicity by using Dunnett’s method in each family of hypotheses and using Bonferroni’s inequality between different families.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.034
Comments Used analysis of covariance model with treatment (placebo, paliperidone palmitate 25, 100, 150 mg eq.) and country as factors and baseline value as a covariate. P-values adjusted for multiplicity for comparison with placebo using Dunnett's test.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in least-squares means
Estimated Value -5.1
Confidence Interval 95%
-9.01 to -1.10
Parameter Dispersion
Type: Standard Error of the mean
Value: 2.01
Estimation Comments The 95% confidence intervals were unadjusted for multiplicity.
2.Secondary Outcome
Title Change in Personal and Social Performance Scale (PSP) Score From Baseline to Week 13 or the Last Post-baseline Assessment.
Hide Description The PSP scale measures the degree of normal function of a subject in interpersonal relationships and social interactions. Scores range from 1 to 100, where 1 is worst and 100 is best. The average change in PSP score for all eligible subjects was measured from the beginning of the study to Week 13 (i.e., the end of the double-blind treatment period) or, if the subject left the study early, from the beginning of the study to the last assessment after baseline.
Time Frame Baseline to 13 weeks or the last post-baseline assessment
Hide Outcome Measure Data
Hide Analysis Population Description
The secondary outcome measures used the intent-to-treat analysis set, which consisted of all enrolled subjects who got at least 1 dose of paliperidone palmitate and had both a baseline and at least 1 post-baseline efficacy measurement during the study. For imputation of missing time points, last observation carried forward (LOCF) was used.
Arm/Group Title Paliperidone Palmitate 25 mg eq. Paliperidone Palmitate 100 mg eq. Paliperidone Palmitate 150 mg eq. Placebo
Hide Arm/Group Description:
Paliperidone palmitate 150 mg eq. (i.m., deltoid muscle) on Day 1, and 25 mg eq. (i.m., gluteal or deltoid muscle, left or right side, at the discretion of the investigator) on Days 8, 36, and 64.
Paliperidone palmitate 150 mg eq. (i.m., deltoid muscle) on Day 1, and 100 mg eq. (i.m., gluteal or deltoid muscle, left or right side, at the discretion of the investigator) on Days 8, 36, and 64.
Paliperidone palmitate 150 mg eq. on Day 1 (i.m., deltoid muscle) and on Days 8, 36, and 64 (i.m., gluteal or deltoid muscle, left or right side, at the discretion of the investigator).
Placebo on Day 1 (i.m., deltoid muscle) and Days 8, 36, and 64 (i.m., gluteal or deltoid muscle, left or right side, at the discretion of the investigator).
Overall Number of Participants Analyzed 155 161 160 160
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
2.9  (15.29) 6.1  (13.59) 8.3  (14.69) 1.7  (15.60)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Paliperidone Palmitate 150 mg eq., Placebo
Comments Analysis of the key secondary endpoint was conducted using an analysis of covariance model with treatment and country as factors, and the baseline PSP score as a covariate. The Dunnett-Bonferroni-based parallel gatekeeping approach was used to adjust for multiple testing.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-values were adjusted for multiplicity between PANSS total score (primary efficacy endpoint) and PSP, as well as different dose levels in comparison with placebo, using the Dunnett-Bonferroni-based parallel gatekeeping method.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in least-squares means
Estimated Value 6.2
Confidence Interval 95%
3.26 to 9.12
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.49
Estimation Comments The 95% confidence intervals were unadjusted for multiplicity.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Paliperidone Palmitate 100 mg eq., Placebo
Comments Analysis of the key secondary endpoint was conducted using an analysis of covariance model with treatment and country as factors, and the baseline PSP score as a covariate. The Dunnett-Bonferroni-based parallel gatekeeping approach was used to adjust for multiple testing.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.007
Comments P-values were adjusted for multiplicity between PANSS total score (primary efficacy endpoint) and PSP, as well as different dose levels in comparison with placebo, using the Dunnett-Bonferroni-based parallel gatekeeping method.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in least-squares means
Estimated Value 4.4
Confidence Interval 95%
1.43 to 7.31
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.50
Estimation Comments The 95% confidence intervals were unadjusted for multiplicity.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Paliperidone Palmitate 25 mg eq., Placebo
Comments Analysis of the key secondary endpoint was conducted using an analysis of covariance model with treatment and country as factors, and the baseline PSP score as a covariate. The Dunnett-Bonferroni-based parallel gatekeeping approach was used to adjust for multiple testing.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.509
Comments P-values were adjusted for multiplicity between PANSS total score (primary efficacy endpoint) and PSP, as well as different dose levels in comparison with placebo, using the Dunnett-Bonferroni-based parallel gatekeeping method.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in least-squares means
Estimated Value 1.0
Confidence Interval 95%
-1.96 to 3.95
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.50
Estimation Comments The 95% confidence intervals were unadjusted for multiplicity.
3.Secondary Outcome
Title Change in Clinical Global Impression-Severity (CGI-S) Scores From Baseline to Week 13 or the Last Post-baseline Assessment
Hide Description The CGI-S rating scale was used to assess the severity of a subject’s overall clinical condition. Scores range from 1 to 7, where 1=best and 7=worst. The change in CGI-S score for all eligible subjects was measured from the beginning of the study to Week 13 (i.e., the end of the double-blind treatment period) or, if the subject left the study early, from the beginning of the study to the last assessment after baseline.
Time Frame Baseline to 13 weeks or the last post-baseline assessment
Hide Outcome Measure Data
Hide Analysis Population Description
The secondary outcome measures used the intent-to-treat analysis set, which consisted of all enrolled subjects who got at least 1 dose of paliperidone palmitate and had both a baseline and at least 1 post-baseline efficacy measurement during the study. For imputation of missing time points, last observation carried forward (LOCF) was used.
Arm/Group Title Paliperidone Palmitate 25 mg eq. Paliperidone Palmitate 100 mg eq. Paliperidone Palmitate 150 mg eq. Placebo
Hide Arm/Group Description:
Paliperidone palmitate 150 mg eq. (i.m., deltoid muscle) on Day 1, and 25 mg eq. (i.m., gluteal or deltoid muscle, left or right side, at the discretion of the investigator) on Days 8, 36, and 64.
Paliperidone palmitate 150 mg eq. (i.m., deltoid muscle) on Day 1, and 100 mg eq. (i.m., gluteal or deltoid muscle, left or right side, at the discretion of the investigator) on Days 8, 36, and 64.
Paliperidone palmitate 150 mg eq. on Day 1 (i.m., deltoid muscle) and on Days 8, 36, and 64 (i.m., gluteal or deltoid muscle, left or right side, at the discretion of the investigator).
Placebo on Day 1 (i.m., deltoid muscle) and Days 8, 36, and 64 (i.m., gluteal or deltoid muscle, left or right side, at the discretion of the investigator).
Overall Number of Participants Analyzed 155 161 160 160
Median (Full Range)
Unit of Measure: Scores on a scale
-1.0
(-3 to 2)
-1.0
(-4 to 2)
-1.0
(-4 to 3)
0.0
(-3 to 2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Paliperidone Palmitate 150 mg eq., Placebo
Comments Analysis of the change in the CGI-S score at end point was performed using an analysis of covariance model on the ranks of the change in score at end point with treatment and country as factors, and (non-ranked) baseline CGI-S score as a covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Comparisons with placebo were without multiplicity adjustment.
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Paliperidone Palmitate 100 mg eq., Placebo
Comments Analysis of the change in the CGI-S score at end point was performed using an analysis of covariance model on the ranks of the change in score at end point with treatment and country as factors, and (non-ranked) baseline CGI-S score as a covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.005
Comments Comparisons with placebo were without multiplicity adjustment.
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Paliperidone Palmitate 25 mg eq., Placebo
Comments Analysis of the change in the CGI-S score at end point was performed using an analysis of covariance model on the ranks of the change in score at end point with treatment and country as factors, and (non-ranked) baseline CGI-S score as a covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.140
Comments Comparisons with placebo were without multiplicity adjustment.
Method ANCOVA
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Paliperidone Palmitate 25 mg eq. Paliperidone Palmitate 100 mg eq. Paliperidone Palmitate 150 mg eq. Placebo
Hide Arm/Group Description Paliperidone palmitate 150 mg eq. (i.m., deltoid muscle) on Day 1, and 25 mg eq. (i.m., gluteal or deltoid muscle, left or right side, at the discretion of the investigator) on Days 8, 36, and 64. Paliperidone palmitate 150 mg eq. (i.m., deltoid muscle) on Day 1, and 100 mg eq. (i.m., gluteal or deltoid muscle, left or right side, at the discretion of the investigator) on Days 8, 36, and 64. Paliperidone palmitate 150 mg eq. on Day 1 (i.m., deltoid muscle) and on Days 8, 36, and 64 (i.m., gluteal or deltoid muscle, left or right side, at the discretion of the investigator). Placebo on Day 1 (i.m., deltoid muscle) and Days 8, 36, and 64 (i.m., gluteal or deltoid muscle, left or right side, at the discretion of the investigator).
All-Cause Mortality
Paliperidone Palmitate 25 mg eq. Paliperidone Palmitate 100 mg eq. Paliperidone Palmitate 150 mg eq. Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Paliperidone Palmitate 25 mg eq. Paliperidone Palmitate 100 mg eq. Paliperidone Palmitate 150 mg eq. Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   15      22      13      23    
Gastrointestinal disorders         
Haemorrhoids  1  0/160 (0.00%)  0 1/165 (0.61%)  1 0/163 (0.00%)  0 0/164 (0.00%)  0
General disorders         
Non-cardiac chest pain  1  0/160 (0.00%)  0 0/165 (0.00%)  0 0/163 (0.00%)  0 1/164 (0.61%)  1
Infections and infestations         
Diverticulitis  1  1/160 (0.63%)  1 0/165 (0.00%)  0 0/163 (0.00%)  0 0/164 (0.00%)  0
Investigations         
Electrocardiogram change  1  0/160 (0.00%)  0 0/165 (0.00%)  0 0/163 (0.00%)  0 1/164 (0.61%)  1
Nervous system disorders         
Cerebrovascular accident  1  0/160 (0.00%)  0 0/165 (0.00%)  0 1/163 (0.61%)  1 0/164 (0.00%)  0
Syncope  1  1/160 (0.63%)  1 0/165 (0.00%)  0 0/163 (0.00%)  0 0/164 (0.00%)  0
Psychiatric disorders         
Schizophrenia  1  9/160 (5.63%)  11 10/165 (6.06%)  10 5/163 (3.07%)  5 10/164 (6.10%)  10
Psychotic disorder  1  3/160 (1.88%)  3 7/165 (4.24%)  7 4/163 (2.45%)  4 7/164 (4.27%)  7
Suicidal ideation  1  3/160 (1.88%)  3 2/165 (1.21%)  2 0/163 (0.00%)  0 3/164 (1.83%)  3
Anxiety  1  0/160 (0.00%)  0 1/165 (0.61%)  1 1/163 (0.61%)  1 0/164 (0.00%)  0
Depression  1  1/160 (0.63%)  1 0/165 (0.00%)  0 1/163 (0.61%)  1 1/164 (0.61%)  1
Suicide attempt  1  0/160 (0.00%)  0 1/165 (0.61%)  1 1/163 (0.61%)  1 0/164 (0.00%)  0
Agitation  1  1/160 (0.63%)  1 0/165 (0.00%)  0 0/163 (0.00%)  0 1/164 (0.61%)  1
Hallucination, auditory  1  1/160 (0.63%)  1 0/165 (0.00%)  0 0/163 (0.00%)  0 0/164 (0.00%)  0
Insomnia  1  1/160 (0.63%)  1 0/165 (0.00%)  0 0/163 (0.00%)  0 0/164 (0.00%)  0
Schizoaffective disorder  1  0/160 (0.00%)  0 1/165 (0.61%)  1 0/163 (0.00%)  0 0/164 (0.00%)  0
Schizophrenia, paranoid type  1  0/160 (0.00%)  0 1/165 (0.61%)  1 0/163 (0.00%)  0 0/164 (0.00%)  0
Acute psychosis  1  0/160 (0.00%)  0 0/165 (0.00%)  0 0/163 (0.00%)  0 1/164 (0.61%)  1
Delusional disorder, persecutory type  1  0/160 (0.00%)  0 0/165 (0.00%)  0 0/163 (0.00%)  0 1/164 (0.61%)  1
Homicidal ideation  1  0/160 (0.00%)  0 0/165 (0.00%)  0 0/163 (0.00%)  0 1/164 (0.61%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 10.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 4%
Paliperidone Palmitate 25 mg eq. Paliperidone Palmitate 100 mg eq. Paliperidone Palmitate 150 mg eq. Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   27      27      28      23    
General disorders         
Injection site pain  1  14/160 (8.75%)  10/165 (6.06%)  13/163 (7.98%)  6/164 (3.66%) 
Nervous system disorders         
Headache  1  17/160 (10.63%)  11/165 (6.67%)  10/163 (6.13%)  12/164 (7.32%) 
Akathisia  1  2/160 (1.25%)  8/165 (4.85%)  9/163 (5.52%)  8/164 (4.88%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 10.1
No information on long-term (ie, more than 13-week) treatment; not designed to detect differences between doses of paliperidone palmitate; not designed to demonstrate efficacy for specific subgroups, such as subjects from a particular country
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: Compound Development Team Leader, Paliperidone
Organization: Johnson & Johnson Pharmaceutical Research & Development
Phone: 609-730-4530
Responsible Party: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier: NCT00590577     History of Changes
Other Study ID Numbers: CR012550
R092670PSY3007
First Submitted: December 21, 2007
First Posted: January 10, 2008
Results First Submitted: August 21, 2009
Results First Posted: October 5, 2009
Last Update Posted: June 4, 2014