Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

An Efficacy and Safety Study of Extended-Release (ER) Paliperidone in Adolescent Participants With Schizophrenia

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: NCT01009047
Recruitment Status : Completed
First Posted : November 6, 2009
Results First Posted : June 21, 2013
Last Update Posted : June 21, 2013
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Schizophrenia
Interventions Drug: Paliperidone extended release (ER)
Drug: Aripiprazole
Enrollment 228
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Paliperidone Extended Release (ER) Aripiprazole
Hide Arm/Group Description Paliperidone ER administered as oral capsule at a dose of 6 milligram (mg) for 1 week and then administered at a dose of either 3, 6 or 9 mg up to Week 26, once daily in the morning. Aripiprazole administered as oral capsule at a dose of 2 mg on Days 1 and 2, 5 mg on Days 3 and 4; 10 mg on Days 5, 6 and 7; and then administered as a dose of either 5 or 10 or 15 mg up to Week 26, once daily in the morning.
Period Title: Overall Study
Started 113 115
Completed 85 89
Not Completed 28 26
Reason Not Completed
Adverse Event             5             0
Lost to Follow-up             0             2
Lack of Efficacy             4             11
Withdrawal by consent             16             11
Other             3             2
Arm/Group Title Paliperidone Extended Release (ER) Aripiprazole Total
Hide Arm/Group Description Paliperidone ER administered as oral capsule at a dose of 6 mg for 1 week and then administered at a dose of either 3, 6 or 9 mg up to Week 26, once daily in the morning. Aripiprazole administered as oral capsule at a dose of 2 mg on Days 1 and 2, 5 mg on Days 3 and 4; 10 mg on Days 5, 6 and 7; and then administered as a dose of either 5 or 10 or 15 mg up to Week 26, once daily in the morning. Total of all reporting groups
Overall Number of Baseline Participants 112 114 226
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 112 participants 114 participants 226 participants
15.3  (1.46) 15.4  (1.45) 15.3  (1.46)
[1]
Measure Description: Number of participants analyzed for this Baseline characteristic is intent to treat (ITT) population which included all randomly assigned participants who received at least 1 dose of double-blind study drug, had both a Baseline measurement and at least 1 Post-Baseline measurement in the double-blind phase. Last observation carried forward (LOCF) method was used.
Sex: Female, Male   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 112 participants 114 participants 226 participants
Female
39
  34.8%
38
  33.3%
77
  34.1%
Male
73
  65.2%
76
  66.7%
149
  65.9%
[1]
Measure Description: Number of participants analyzed for this Baseline characteristic is intent to treat (ITT) population which included all randomly assigned participants who received at least 1 dose of double-blind study drug, had both a Baseline measurement and at least 1 Post-Baseline measurement in the double-blind phase. Last observation carried forward (LOCF) method was used.
1.Primary Outcome
Title Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) Total Score at Day 56
Hide Description The PANSS is a 30-item scale with each item rated on a scale of 1 (absent) to 7 (extreme psychopathology), designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The PANSS total score consists of the sum of all 30 PANSS items and ranges from 30 to 210. Higher scores indicate worsening.
Time Frame Baseline and Day 56
Hide Outcome Measure Data
Hide Analysis Population Description
The intent-to-treat (ITT) population included all randomly assigned participants who received at least 1 dose of double-blind study drug, had both a Baseline measurement and at least 1 Post-Baseline measurement in the double-blind phase. Last observation carried forward (LOCF) method was used.
Arm/Group Title Paliperidone Extended Release (ER) Aripiprazole
Hide Arm/Group Description:
Paliperidone ER administered as oral capsule at a dose of 6 mg for 1 week and then administered at a dose of either 3, 6 or 9 mg up to Week 26, once daily in the morning.
Aripiprazole administered as oral capsule at a dose of 2 mg on Days 1 and 2, 5 mg on Days 3 and 4; 10 mg on Days 5, 6 and 7; and then administered as a dose of either 5 or 10 or 15 mg up to Week 26, once daily in the morning.
Overall Number of Participants Analyzed 112 114
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Baseline 89.6  (12.22) 92.0  (12.09)
Change at Day 56 -19.3  (13.80) -19.8  (14.56)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Paliperidone Extended Release (ER), Aripiprazole
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.935
Comments Analysis of covariance (ANCOVA) model with treatment (paliperidone ER, aripiprazole) and country as factors, and baseline value as a covariate was used.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least-squares (LS) mean difference
Estimated Value 0.1
Confidence Interval (2-Sided) 95%
-3.46 to 3.76
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.83
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Change From Baseline in PANSS Total Score at Day 182
Hide Description The PANSS is a 30-item scale designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items and ranges from 30 to 210. Higher scores indicate worsening.
Time Frame Baseline and Day 182
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population included all randomly assigned participants who received at least 1 dose of double-blind study drug, had both a Baseline measurement and at least 1 Post-Baseline measurement in the double-blind phase. Last observation carried forward (LOCF) method was used.
Arm/Group Title Paliperidone Extended Release (ER) Aripiprazole
Hide Arm/Group Description:
Paliperidone ER administered as oral capsule at a dose of 6 mg for 1 week and then administered at a dose of either 3, 6 or 9 mg up to Week 26, once daily in the morning.
Aripiprazole administered as oral capsule at a dose of 2 mg on Days 1 and 2, 5 mg on Days 3 and 4; 10 mg on Days 5, 6 and 7; and then administered as a dose of either 5 or 10 or 15 mg up to Week 26, once daily in the morning.
Overall Number of Participants Analyzed 112 114
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Baseline 89.6  (12.22) 92.0  (12.09)
Change at Day 182 -25.6  (16.88) -26.8  (18.82)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Paliperidone Extended Release (ER), Aripiprazole
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.877
Comments Analysis of covariance (ANCOVA) model with treatment groups (paliperidone ER, aripiprazole) and country as factors, and baseline value as a covariate was used.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -0.3
Confidence Interval (2-Sided) 95%
-4.68 to 4.00
Parameter Dispersion
Type: Standard Error of the mean
Value: 2.20
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Change From Baseline in Marder Factor Negative Symptoms Score at Day 56 and 182
Hide Description The PANSS negative subscale based on marder factor assesses 7 negative-symptoms of schizophrenia. Negative symptoms represent a diminution or loss of normal functions. The symptoms are rated on a 7-point scale, with a range of 7 (absent) to 49 (extreme psychopathology).
Time Frame Baseline, Day 56 and Day 182
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population included all randomly assigned participants who received at least 1 dose of double-blind study drug, had both a Baseline measurement and at least 1 Post-Baseline measurement in the double-blind phase. Last observation carried forward (LOCF) method was used.
Arm/Group Title Paliperidone Extended Release (ER) Aripiprazole
Hide Arm/Group Description:
Paliperidone ER administered as oral capsule at a dose of 6 mg for 1 week and then administered at a dose of either 3, 6 or 9 mg up to Week 26, once daily in the morning.
Aripiprazole administered as oral capsule at a dose of 2 mg on Days 1 and 2, 5 mg on Days 3 and 4; 10 mg on Days 5, 6 and 7; and then administered as a dose of either 5 or 10 or 15 mg up to Week 26, once daily in the morning.
Overall Number of Participants Analyzed 112 114
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Baseline 23.2  (4.92) 23.3  (4.54)
Change at Day 56 -4.3  (4.56) -4.7  (4.61)
Change at Day 182 -6.0  (5.51) -6.2  (5.84)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Paliperidone Extended Release (ER), Aripiprazole
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.341
Comments Day 56: Analysis of covariance (ANCOVA) model with treatment (paliperidone ER, aripiprazole) and country as factors, and baseline value as a covariate was used.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 0.5
Confidence Interval (2-Sided) 95%
-0.55 to 1.59
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.54
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Paliperidone Extended Release (ER), Aripiprazole
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.723
Comments Day 182: Analysis of covariance (ANCOVA) model with treatment (paliperidone ER, aripiprazole) and country as factors, and baseline value as a covariate was used.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 0.2
Confidence Interval (2-Sided) 95%
-1.06 to 1.53
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.66
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Change From Baseline in Other Marder Factors Scores at Day 56 and 182
Hide Description The subscales based on marder factors are: positive symptoms, disorganised thoughts factor, uncontrolled hostility/excitement factor, and anxiety/depression factor. The symptoms are rated on a 7-point scale, with a range of 8 to 56 for positive symptoms, 7 to 49 for disorganized thoughts and 4 to 28 for Uncontrolled hostility/excitement and anxiety/depression. Higher score indicate worsening.
Time Frame Baseline, Day 56 and 182
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population included all randomly assigned participants who received at least 1 dose of double-blind study drug, had both a Baseline measurement and at least 1 Post-Baseline measurement in the double-blind phase. Last observation carried forward (LOCF) method was used.
Arm/Group Title Paliperidone Extended Release (ER) Aripiprazole
Hide Arm/Group Description:
Paliperidone ER administered as oral capsule at a dose of 6 mg for 1 week and then administered at a dose of either 3, 6 or 9 mg up to Week 26, once daily in the morning.
Aripiprazole administered as oral capsule at a dose of 2 mg on Days 1 and 2, 5 mg on Days 3 and 4; 10 mg on Days 5, 6 and 7; and then administered as a dose of either 5 or 10 or 15 mg up to Week 26, once daily in the morning.
Overall Number of Participants Analyzed 112 114
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Baseline: Positive symptoms 24.6  (4.08) 24.9  (4.32)
Change at Day 56: Positive symptoms -6.1  (4.96) -5.6  (4.83)
Change at Day 182: Positive symptoms -7.8  (5.82) -7.8  (6.03)
Baseline: Negative symptoms 23.2  (4.92) 23.3  (4.54)
Change at Day 56: Negative symptoms -4.3  (4.56) -4.7  (4.61)
Change at Day 182: Negative symptoms -6.0  (5.51) -6.2  (5.84)
Baseline: Disorganized thoughts 21.4  (4.40) 22.1  (3.86)
Change at Day 56: Disorganized thoughts -4.0  (3.34) -4.1  (3.40)
Change at Day 182: Disorganized thoughts -5.5  (4.18) -5.7  (4.46)
Baseline: Uncontrolled hostility 10.7  (3.19) 11.7  (3.48)
Change at Day 56: Uncontrolled hostility -2.5  (2.67) -2.9  (3.05)
Change at Day 182: Uncontrolled hostility -3.2  (3.11) -3.8  (3.97)
Baseline: Anxiety/depression 9.7  (3.17) 10.0  (3.26)
Change at Day 56: Anxiety/depression -2.4  (3.08) -2.6  (2.81)
Change at Day 182: Anxiety/depression -3.0  (3.29) -3.2  (3.17)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Paliperidone Extended Release (ER), Aripiprazole
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.351
Comments Change at Day 56: Positive Symptoms - ANCOVA model with treatment groups (paliperidone ER, aripiprazole) and country as factors, and baseline value as a covariate.
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Paliperidone Extended Release (ER), Aripiprazole
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.691
Comments Change at Day 182:Positive Symptoms - ANCOVA model with treatment groups (paliperidone ER, aripiprazole) and country as factors, and baseline value as a covariate was used.
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Paliperidone Extended Release (ER), Aripiprazole
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.965
Comments Change at Day 56: Disorganized thoughts - ANCOVA model with treatment groups (paliperidone ER, aripiprazole) and country as factors, and baseline value as a covariate was used.
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Paliperidone Extended Release (ER), Aripiprazole
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.766
Comments Change at Day 182: Disorganized thoughts - ANCOVA model with treatment groups (paliperidone ER, aripiprazole) and country as factors, and baseline value as a covariate was used.
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Paliperidone Extended Release (ER), Aripiprazole
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.984
Comments Change at Day 56: Uncontrolled hostility/ excitement - ANCOVA model with treatment groups (paliperidone ER, aripiprazole) and country as factors, and baseline value as a covariate was used.
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Paliperidone Extended Release (ER), Aripiprazole
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.985
Comments Change at Day 182: Uncontrolled Hositility/ Excitement - ANCOVA model with treatment groups (paliperidone ER, aripiprazole) and country as factors, and baseline value as a covariate was used.
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Paliperidone Extended Release (ER), Aripiprazole
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.803
Comments Change at Day 56: Anxiety/ depression - ANCOVA model with treatment groups (paliperidone ER, aripiprazole) and country as factors, and baseline value as a covariate.
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Paliperidone Extended Release (ER), Aripiprazole
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.745
Comments Change at Day 182: Anxiety/ depression - ANCOVA model with treatment groups (paliperidone ER, aripiprazole) and country as factors, and baseline value as a covariate.
Method ANCOVA
Comments [Not Specified]
5.Secondary Outcome
Title Change From Baseline in Other PANSS Factors and Subscales at Day 56 and 182
Hide Description The PANSS provides a total score (sum of the scores of all 30 items) and scores for 3 subscales, the positive subscale (7 items), the negative subscale (7 items), and the general psychopathology subscale (16 items), each rated on a scale of 1 (absent) to 7 (extreme).
Time Frame Baseline, Day 56 and 182
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population included all randomly assigned participants who received at least 1 dose of double-blind study drug, had both a Baseline measurement and at least 1 Post-Baseline measurement in the double-blind phase. Last observation carried forward (LOCF) method was used.
Arm/Group Title Paliperidone Extended Release (ER) Aripiprazole
Hide Arm/Group Description:
Paliperidone ER administered as oral capsule at a dose of 6 mg for 1 week and then administered at a dose of either 3, 6 or 9 mg up to Week 26, once daily in the morning.
Aripiprazole administered as oral capsule at a dose of 2 mg on Days 1 and 2, 5 mg on Days 3 and 4; 10 mg on Days 5, 6 and 7; and then administered as a dose of either 5 or 10 or 15 mg up to Week 26, once daily in the morning.
Overall Number of Participants Analyzed 112 114
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Baseline: Positive Subscale 21.5  (4.14) 22.5  (4.26)
Change at Day 56: Positive Subscale -6.4  (4.54) -6.2  (4.91)
Change at Day 182: Positive Subscale -8.0  (5.16) -8.3  (6.09)
Baseline: Negative Subscale 23.8  (4.55) 24.2  (4.32)
Change at Day 56: Negative Subscale -4.2  (4.25) 4.5  (4.25)
Change at Day 182: Negative Subscale -5.7  (5.15) -6.1  (5.47)
Baseline: General Psychopathology 44.3  (7.47) 45.3  (7.01)
Change at Day 56: General Psychopathology -8.7  (7.35) -9.1  (7.25)
Change at Day 182: General Psychopathology -11.9  (9.02) -12.4  (9.41)
6.Secondary Outcome
Title Number of Participants With Clinical Stability
Hide Description Clinical stability is defined as a decrease of 20 percent or more from Baseline in PANSS total score and CGI-S score less than or equal to 4 at Days 56 and 182, no hospitalizations due to psychiatric illness and no emergence of clinically significant suicidal or homicidal ideation during the maintenance phase.
Time Frame Day 56 and 182
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population included all randomly assigned participants who received at least 1 dose of double-blind study drug, had both a Baseline measurement and at least 1 Post-Baseline measurement in the double-blind phase. Last observation carried forward (LOCF) method was used.
Arm/Group Title Paliperidone Extended Release (ER) Aripiprazole
Hide Arm/Group Description:
Paliperidone ER administered as oral capsule at a dose of 6 mg for 1 week and then administered at a dose of either 3, 6 or 9 mg up to Week 26, once daily in the morning.
Aripiprazole administered as oral capsule at a dose of 2 mg on Days 1 and 2, 5 mg on Days 3 and 4; 10 mg on Days 5, 6 and 7; and then administered as a dose of either 5 or 10 or 15 mg up to Week 26, once daily in the morning.
Overall Number of Participants Analyzed 112 114
Measure Type: Number
Unit of Measure: Participants
58 68
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Paliperidone Extended Release (ER), Aripiprazole
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.296
Comments Generalized Cochran- Mantel- Haenszel test for row mean score differences controlling for country was used.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
7.Secondary Outcome
Title Change From Baseline in Clinical Global Impression - Severity (CGI-S) Score at Days 56 and 182
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 participant. A rating of 1 is equivalent to "Normal, not at all ill" and a rating of 7 is equivalent to "Among the most extremely ill participants". Higher scores indicate worsening.
Time Frame Baseline, Day 56 and 182
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population included all randomly assigned participants who received at least 1 dose of double-blind study drug, had both a Baseline measurement and at least 1 Post-Baseline measurement in the double-blind phase. Last observation carried forward (LOCF) method was used.
Arm/Group Title Paliperidone Extended Release (ER) Aripiprazole
Hide Arm/Group Description:
Paliperidone ER administered as oral capsule at a dose of 6 mg for 1 week and then administered at a dose of either 3, 6 or 9 mg up to Week 26, once daily in the morning.
Aripiprazole administered as oral capsule at a dose of 2 mg on Days 1 and 2, 5 mg on Days 3 and 4; 10 mg on Days 5, 6 and 7; and then administered as a dose of either 5 or 10 or 15 mg up to Week 26, once daily in the morning.
Overall Number of Participants Analyzed 112 114
Median (Full Range)
Unit of Measure: Units on a scale
Baseline
4.0
(3 to 6)
4.0
(3 to 6)
Change at Day 56
-1.0
(-4 to 0)
-1
(-3 to 1)
Change at Day 182
-1.0
(-4 to 1)
-1.0
(-4 to 1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Paliperidone Extended Release (ER), Aripiprazole
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.843
Comments Change at Day 56: ANCOVA model on ranks with treatment groups (paliperidone ER, aripiprazole) and country as factors, and baseline value (unranked) as a covariate was used.
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Paliperidone Extended Release (ER)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.914
Comments Change at Day 182: ANCOVA model on ranks with treatment groups (paliperidone ER, aripiprazole) and country as factors, and baseline value (unranked) as a covariate was used.
Method ANCOVA
Comments [Not Specified]
8.Secondary Outcome
Title Change From Baseline in Personal and Social Performance (PSP) Scores at Day 56 and 182
Hide Description The PSP scale assesses degree of a participants' dysfunction within 4 domains of behavior: socially useful activities, personal and social relationships, self-care, and disturbing and aggressive behavior. The results of the assessment are converted to a numerical score to rate degree of difficulty (1=absent to 6=very severe) in each of the 4 domains. Based on 4 domains there will be 1 total score (total score ranges from 1 to 100, divided into 10 equal intervals). Participants with score of 71 to 100 have mild degree of difficulty; from 31 to 70, varying degrees of disability; less than or equal to 30, functioning so poorly as to require intensive supervision.
Time Frame Baseline, Day 56 and Day 182
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population included all randomly assigned participants who received at least 1 dose of double-blind study drug, had both a Baseline measurement and at least 1 Post-Baseline measurement in the double-blind phase. Last observation carried forward (LOCF) method was used.
Arm/Group Title Paliperidone Extended Release (ER) Aripiprazole
Hide Arm/Group Description:
Paliperidone ER administered as oral capsule at a dose of 6 mg for 1 week and then administered at a dose of either 3, 6 or 9 mg up to Week 26, once daily in the morning.
Aripiprazole administered as oral capsule at a dose of 2 mg on Days 1 and 2, 5 mg on Days 3 and 4; 10 mg on Days 5, 6 and 7; and then administered as a dose of either 5 or 10 or 15 mg up to Week 26, once daily in the morning.
Overall Number of Participants Analyzed 112 114
Mean (Standard Deviation)
Unit of Measure: Units on a Scale
Baseline 49.8  (10.32) 49.2  (10.21)
Change at Day 56 12.2  (11.72) 12.2  (10.17)
Change at Day 182 17.1  (14.46) 17.1  (14.03)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Paliperidone Extended Release (ER), Aripiprazole
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.895
Comments Change at Day 56: Analysis of covariance (ANCOVA) model with treatment groups(paliperidone ER, aripiprazole) and country as factors, and baseline value as a covariate was used.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 0.2
Confidence Interval (2-Sided) 95%
-2.34 to 2.67
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.27
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Paliperidone Extended Release (ER), Aripiprazole
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.705
Comments Change at Day 182: Analysis of covariance (ANCOVA) model with treatment groups (paliperidone ER, aripiprazole) and country as factors, and baseline value as a covariate was used.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 0.6
Confidence Interval (2-Sided) 95%
-2.64 to 3.89
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.66
Estimation Comments [Not Specified]
9.Secondary Outcome
Title Number of Participants With PANSS Response
Hide Description The PANSS is a 30-item scale with each item rated on a scale of 1 (absent) to 7 (extreme psychopathology), designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The PANSS total score consists of the sum of all 30 PANSS items and ranges from 30 to 210. Participants with PANSS response were defined as those who achieved greater than or equal to 20 percent or higher reduction from Baseline in the PANSS total score at Day 56 and 182.
Time Frame Day 56 and 182
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population included all randomly assigned participants who received at least 1 dose of double-blind study drug, had both a Baseline measurement and at least 1 Post-Baseline measurement in the double-blind phase. Last observation carried forward (LOCF) method was used.
Arm/Group Title Paliperidone Extended Release (ER) Aripiprazole
Hide Arm/Group Description:
Paliperidone ER administered as oral capsule at a dose of 6 mg for 1 week and then administered at a dose of either 3, 6 or 9 mg up to Week 26, once daily in the morning.
Aripiprazole administered as oral capsule at a dose of 2 mg on Days 1 and 2, 5 mg on Days 3 and 4; 10 mg on Days 5, 6 and 7; and then administered as a dose of either 5 or 10 or 15 mg up to Week 26, once daily in the morning.
Overall Number of Participants Analyzed 112 114
Measure Type: Number
Unit of Measure: Participants
Day 56 76 87
Day 182 86 93
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Paliperidone Extended Release (ER), Aripiprazole
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.119
Comments Day 56: Generalized Cochran-Mantel-Haenszel test for row mean score differences was used.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Paliperidone Extended Release (ER), Aripiprazole
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.444
Comments Day 182: Generalized Cochran-Mantel-Haenszel test for row mean score differences was used.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Time Frame Baseline up to Week 26
Adverse Event Reporting Description The safety population included all randomly assigned participants who received at least 1 dose of double-blind study drug. A total of 113 participants in the paliperidone ER group and 114 participants in the aripiprazole group received at least 1 dose of double-blind study medication and were included in the safety analysis set.
 
Arm/Group Title Paliperidone Extended Release (ER) Aripiprazole
Hide Arm/Group Description Paliperidone ER administered as oral capsule at a dose of 6 mg for 1 week and then administered at a dose of either 3, 6 or 9 mg up to Week 26, once daily in the morning. Aripiprazole administered as oral capsule at a dose of 2 mg on Days 1 and 2, 5 mg on Days 3 and 4; 10 mg on Days 5, 6 and 7; and then administered as a dose of either 5 or 10 or 15 mg up to Week 26, once daily in the morning.
All-Cause Mortality
Paliperidone Extended Release (ER) Aripiprazole
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Paliperidone Extended Release (ER) Aripiprazole
Affected / at Risk (%) Affected / at Risk (%)
Total   7/113 (6.19%)   7/114 (6.14%) 
Infections and infestations     
Sinusitis * 1  1/113 (0.88%)  0/114 (0.00%) 
Upper respiratory infection * 1  0/113 (0.00%)  1/114 (0.88%) 
Psychiatric disorders     
Agitation * 1  1/113 (0.88%)  1/114 (0.88%) 
Anxiety * 1  1/113 (0.88%)  0/114 (0.00%) 
Schizophrenia * 1  1/113 (0.88%)  4/114 (3.51%) 
Schizophrenia, paranoid type * 1  1/113 (0.88%)  0/114 (0.00%) 
Suicide attempt * 1  1/113 (0.88%)  0/114 (0.00%) 
Psychotic disorder * 1  1/113 (0.88%)  1/114 (0.88%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA Version 15.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Paliperidone Extended Release (ER) Aripiprazole
Affected / at Risk (%) Affected / at Risk (%)
Total   63/113 (55.75%)   50/114 (43.86%) 
Gastrointestinal disorders     
Vomiting * 1  8/113 (7.08%)  1/114 (0.88%) 
Nausea * 1  4/113 (3.54%)  7/114 (6.14%) 
General disorders     
Asthenia * 1  6/113 (5.31%)  1/114 (0.88%) 
Investigations     
Weight increased * 1  12/113 (10.62%)  7/114 (6.14%) 
Metabolism and nutrition disorders     
Decreased appetite * 1  2/113 (1.77%)  6/114 (5.26%) 
Musculoskeletal and connective tissue disorders     
Muscle rigidity * 1  7/113 (6.19%)  3/114 (2.63%) 
Nervous system disorders     
Headache * 1  12/113 (10.62%)  5/114 (4.39%) 
Akathisia * 1  13/113 (11.50%)  9/114 (7.89%) 
Somnolence * 1  12/113 (10.62%)  12/114 (10.53%) 
Tremor * 1  12/113 (10.62%)  11/114 (9.65%) 
Sedation * 1  6/113 (5.31%)  3/114 (2.63%) 
Psychiatric disorders     
Insomnia * 1  6/113 (5.31%)  9/114 (7.89%) 
Schizophrenia * 1  3/113 (2.65%)  10/114 (8.77%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA Version 15.0
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.
If an Investigator wishes to publish information from the study, a copy of the manuscript must be provided to the Sponsor for review at least 60 days before submission for publication. If requested by the Sponsor, the Investigator will withhold it up to an additional 60 days to allow for filing of a patent application. The Sponsor will not change or suppress the scientific content. For multi-center study, results may not be published before the primary endpoints of a study have been published.
Results Point of Contact
Name/Title: Senior Director, Clinical Leader
Organization: Janssen Research & Development, LLC
Phone: +1-609-730-2436
Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT01009047     History of Changes
Other Study ID Numbers: CR016675
R076477PSZ3003 ( Other Identifier: Janssen Research & Development, LLC )
First Submitted: November 5, 2009
First Posted: November 6, 2009
Results First Submitted: March 29, 2013
Results First Posted: June 21, 2013
Last Update Posted: June 21, 2013