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

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ClinicalTrials.gov Identifier: NCT00566631
Recruitment Status : Completed
First Posted : December 3, 2007
Results First Posted : August 2, 2013
Last Update Posted : August 2, 2013
Sponsor:
Information provided by (Responsible Party):
Janssen-Cilag International NV

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Schizophrenia
Intervention Drug: Paliperidone
Enrollment 294
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Paliperidone Extended Release (ER)
Hide Arm/Group Description Paliperidone ER tablet in flexible daily dose of 3, 6, 9 or 12 milligram (mg) as per Investigators’ discretion was given once daily orally for 6 weeks in the core treatment phase and no longer than 12 months in the extension phase after the completion of core treatment phase.
Period Title: Part 1: Core Treatment Phase
Started 294
Completed 234
Not Completed 60
Reason Not Completed
Lack of Efficacy             18
Physician Decision             1
Adverse Event             9
Lost to Follow-up             4
Withdrawal by Subject             26
Moved to a penitentiary hospital             1
Met exclusion criteria             1
Period Title: Between Treatment and Extension Phase
Started 234
Completed 139
Not Completed 95
Reason Not Completed
Participants not willing to participate             95
Period Title: Part 2: Extension Phase
Started 139
Completed 57
Not Completed 82
Reason Not Completed
Lack of Efficacy             25
Withdrawal by Subject             34
Adverse Event             11
Lost to Follow-up             6
Death             1
Other             5
Arm/Group Title Paliperidone Extended Release (ER)
Hide Arm/Group Description Paliperidone ER tablet in flexible daily dose of 3, 6, 9 or 12 milligram (mg) as per Investigators’ discretion was given once daily orally for 6 weeks in the core treatment phase and no longer than 12 months in the extension phase after the completion of core treatment phase.
Overall Number of Baseline Participants 294
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 294 participants
40.3  (12.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 294 participants
Female
138
  46.9%
Male
156
  53.1%
1.Primary Outcome
Title Number of Participants With Treatment Response Based on Total PANSS Scale Score
Hide Description Response was defined as decrease of at least 30 percent in total Positive and Negative Syndrome Scale (PANSS) score from Baseline to endpoint of core phase (which is, Day 42 or early discontinuation). The PANSS is a 30-item scale designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, & 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 sum of all 30 PANSS items & ranges from 30 to 210. Higher scores indicate worsening.
Time Frame Day 42 or early discontinuation
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT) population included all participants who received at least one dose of paliperidone ER and provided at least 1 post-baseline efficacy measurement.
Arm/Group Title Paliperidone Extended Release (ER)
Hide Arm/Group Description:
Paliperidone ER tablet in flexible daily dose of 3, 6, 9 or 12 milligram (mg) as per Investigators’ discretion was given once daily orally for 6 weeks in the core treatment phase and no longer than 12 months in the extension phase after the completion of core treatment phase.
Overall Number of Participants Analyzed 294
Measure Type: Number
Unit of Measure: Participants
195
2.Secondary Outcome
Title Change From Baseline in Total Positive and Negative Symptom Scale (PANSS) Score at Day 2, 3, 4, 5, 7, 14, 28, 42 and Final Evaluation (Day 42 or Early Discontinuation)
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. Final evaluation is the last post-baseline visit with data.
Time Frame Baseline, Day 2, 3, 4, 5, 7, 14, 28, 42 and Final Evaluation (Day 42 or early discontinuation)
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population included all participants who received at least one dose of paliperidone ER and provided at least 1 post-baseline efficacy measurement. “n" signifies those participants who were evaluated for this measure at given time points.
Arm/Group Title Paliperidone Extended Release (ER)
Hide Arm/Group Description:
Paliperidone ER tablet in flexible daily dose of 3, 6, 9 or 12 milligram (mg) as per Investigators’ discretion was given once daily orally for 6 weeks in the core treatment phase and no longer than 12 months in the extension phase after the completion of core treatment phase.
Overall Number of Participants Analyzed 294
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Baseline (n=294) 100.2  (17.2)
Change at Day 2 (n=294) -2.3  (5.3)
Change at Day 3 (n=287) -5.8  (7.9)
Change at Day 4 (n=288) -10.3  (11.3)
Change at Day 5 (n=284) -13.3  (13.3)
Change at Day 7 (n=286) -17.4  (15.5)
Change at Day 14 (n=276) -22.3  (16.0)
Change at Day 28 (n=254) -27.2  (16.6)
Change at Day 42 (n=234) -32.1  (17.5)
Change at Final Evaluation (n=294) -27.5  (20.1)
3.Secondary Outcome
Title Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Marder Subscale Scores at Day 42 and Final Evaluation (Day 42 or Early Discontinuation)
Hide Description The PANSS is a 30-item scale to assess neuropsychiatric symptoms of schizophrenia. The symptoms are rated on a 7-point scale from 1 (absent) to 7 (extreme psychopathology). Positive symptoms subscale consists of 8 items with total score range of 8-56; negative symptoms and disorganized thoughts subscale, consists of 7 items with total score range of 7-49, uncontrolled hostility/excitement (H/E) subscale and anxiety/depression subscale, each consists of 4 items with total score range of 4-28. Higher score indicates greater severity. Final evaluation is the last post-baseline visit with data.
Time Frame Baseline, Day 42 and Final Evaluation (Day 42 or early discontinuation)
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population included all participants who received at least one dose of paliperidone ER and provided at least 1 post-baseline efficacy measurement.
Arm/Group Title Paliperidone Extended Release (ER)
Hide Arm/Group Description:
Paliperidone ER tablet in flexible daily dose of 3, 6, 9 or 12 milligram (mg) as per Investigators’ discretion was given once daily orally for 6 weeks in the core treatment phase and no longer than 12 months in the extension phase after the completion of core treatment phase.
Overall Number of Participants Analyzed 294
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Positive Score: Baseline 28.8  (5.8)
Positive Score: Change at Day 42 -10.6  (5.9)
Positive Score: Change at Final Evaluation -9.1  (6.7)
Negative Score: Baseline 24.8  (6.1)
Negative Score: Change at Day 42 -6.5  (5.1)
Negative Score: Change at Final Evaluation -5.7  (5.3)
Disorganized Thoughts: Baseline 23.4  (4.9)
Disorganized Thoughts: Change at Day 42 -6.5  (4.6)
Disorganized Thoughts: Change at Final Evaluation -5.6  (5.0)
Uncontrolled H/E: Baseline 10.6  (3.7)
Uncontrolled H/E: Change at Day 42 -3.8  (3.2)
Uncontrolled H/E: Change at Final Evaluation -3.2  (3.8)
Anxiety/Depression: Baseline 12.5  (3.2)
Anxiety/Depression: Change at Day 42 -4.8  (3.2)
Anxiety/Depression: Change at Final Evaluation -3.9  (3.7)
4.Secondary Outcome
Title Percentage of Participants With Treatment Response Greater Than (>) 20 Percent, 40 Percent and 50 Percent in Total Positive and Negative Syndrome Scale (PANSS) Score
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. Final evaluation is the last post-baseline visit with data.
Time Frame Day 2, 3, 4, 5, 7, 14, 28, 42 and Final Evaluation (Day 42 or early discontinuation)
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population included all participants who received at least one dose of paliperidone ER and provided at least 1 post-baseline efficacy measurement.
Arm/Group Title Paliperidone Extended Release (ER)
Hide Arm/Group Description:
Paliperidone ER tablet in flexible daily dose of 3, 6, 9 or 12 milligram (mg) as per Investigators’ discretion was given once daily orally for 6 weeks in the core treatment phase and no longer than 12 months in the extension phase after the completion of core treatment phase.
Overall Number of Participants Analyzed 294
Measure Type: Number
Unit of Measure: Percentage of participants
Treatment Response>20 Percent at Day 2 4.4
Treatment Response>20 Percent at Day 3 12.9
Treatment Response>20 Percent at Day 4 29.9
Treatment Response>20 percent at Day 5 39.4
Treatment Response>20 Percent at Day 7 55.6
Treatment Response>20 Percent at Day 14 72.1
Treatment Response>20 Percent at Day 28 79.9
Treatment Response>20 percent at Day 42 87.6
Treatment Response>20 Percent at Final Evaluation 76.5
Treatment Response>40 Percent at Day 2 0
Treatment Response>40 Percent at Day 3 1.7
Treatment Response>40 Percent at Day 4 6.9
Treatment Response>40 Percent at Day 5 11.6
Treatment Response>40 Percent at Day 7 19.6
Treatment Response>40 Percent at Day 14 33.7
Treatment Response>40 Percent at Day 28 48.0
Treatment Response>40 Percent at Day 42 59.4
Treatment Response>40 Percent at Final Evaluation 51.4
Treatment Response>50 Percent at Day 2 0
Treatment Response>50 Percent at Day 3 0
Treatment Response>50 Percent at Day 4 2.8
Treatment Response>50 Percent at Day 5 7.4
Treatment Response>50 Percent at Day 7 11.2
Treatment Response>50 Percent at Day 14 18.1
Treatment Response>50 Percent at Day 28 29.9
Treatment Response>50 Percent at Day 42 41.5
Treatment Response>50 Percent at Final Evaluation 34.7
5.Secondary Outcome
Title Change From Baseline in Clinical Global Impression -Severity (CGI-S) Score at Day 7, 14, 28, 42 and Final Evaluation (Day 42 or Early Discontinuation)
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. Final evaluation is the last post-baseline visit with data.
Time Frame Baseline, Day 7, 14, 28, 42 and Final Evaluation (Day 42 or early discontinuation)
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population included all participants who received at least 1 dose of paliperidone ER and provided at least 1 post-baseline efficacy measurement. “N” (number of participants analyzed) signifies those participants who were evaluable for this measure and “n" signifies those participants who were evaluated for this measure at given time points.
Arm/Group Title Paliperidone Extended Release (ER)
Hide Arm/Group Description:
Paliperidone ER tablet in flexible daily dose of 3, 6, 9 or 12 milligram (mg) as per Investigators’ discretion was given once daily orally for 6 weeks in the core treatment phase and no longer than 12 months in the extension phase after the completion of core treatment phase.
Overall Number of Participants Analyzed 289
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Baseline (n=289) 3.9  (0.7)
Change at Day 7 (n=286) -0.6  (0.7)
Change at Day 14 (n=275) -0.9  (0.8)
Change at Day 28 (n=253) -1.2  (0.9)
Change at Day 42 (n=234) -1.5  (0.9)
Change at Final Evaluation (n=289) -1.2  (1.0)
6.Secondary Outcome
Title Change From Baseline in Personal and Social Performance Scale (PSP) Score at Day 7, 14, 28, 42 and Final Evaluation (Day 42 or Early Discontinuation)
Hide Description The PSP assesses the degree of dysfunction within 4 domains of behavior: socially useful activities, personal & social relationships, self-care & disturbing and aggressive behavior. The score ranges from 1 to 100, divided into 10 equal intervals to rate the degree of difficulty (1, absent to 6, very severe) in each of 4 domains. Participants with a score of 71 to 100 have a 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. Final evaluation is the last post-baseline visit with data.
Time Frame Baseline, Day 7, 14, 28, 42 and Final Evaluation (Day 42 or early discontinuation)
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population included all participants who received at least 1 dose of paliperidone ER and provided at least 1 post-baseline efficacy measurement. “N” (number of participants analyzed) signifies those participants who were evaluable for this measure and “n" signifies those participants who were evaluated for this measure at given time points.
Arm/Group Title Paliperidone Extended Release (ER)
Hide Arm/Group Description:
Paliperidone ER tablet in flexible daily dose of 3, 6, 9 or 12 milligram (mg) as per Investigators’ discretion was given once daily orally for 6 weeks in the core treatment phase and no longer than 12 months in the extension phase after the completion of core treatment phase.
Overall Number of Participants Analyzed 290
Mean (Standard Deviation)
Unit of Measure: Units on a Scale
Baseline (n=290) 50.0  (14.3)
Change at Day 7 (n=287) 6.3  (9.5)
Change at Day 14 (n=276) 9.9  (10.5)
Change at Day 28 (n=254) 13.8  (12.3)
Change at Day 42 (n=235) 16.1  (13.9)
Change at Final Evaluation (n=290) 13.7  (14.4)
7.Secondary Outcome
Title Change From Baseline in Quality of Sleep Evaluation Score at Day 7, 14, 28, 42 and Final Evaluation (Day 42 or Early Discontinuation)
Hide Description The sleep evaluation scale is a self-administered scale that rates quality of sleep. Participants indicate on an 11-point scale that how well they have slept within the previous 7 days, score ranged from 0 (very badly) to 10 (very well). Final evaluation is the last post-baseline visit with data.
Time Frame Baseline, Day 7, 14, 28, 42 and Final Evaluation (Day 42 or early discontinuation)
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population included all participants who received at least 1 dose of paliperidone ER and provided at least 1 post-baseline efficacy measurement. “N” (number of participants analyzed) signifies those participants who were evaluable for this measure and “n" signifies those participants who were evaluated for this measure at given time points.
Arm/Group Title Paliperidone Extended Release (ER)
Hide Arm/Group Description:
Paliperidone ER tablet in flexible daily dose of 3, 6, 9 or 12 milligram (mg) as per Investigators’ discretion was given once daily orally for 6 weeks in the core treatment phase and no longer than 12 months in the extension phase after the completion of core treatment phase.
Overall Number of Participants Analyzed 286
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Baseline (n=286) 5.4  (2.8)
Change at Day 7 (n=280) 1.4  (2.9)
Change at Day 14 (n=273) 1.7  (2.9)
Change at Day 28 (n=250) 2.1  (3.0)
Change at Day 42 (n=234) 2.6  (2.9)
Change at Final Evaluation (n=286) 2.1  (3.2)
8.Secondary Outcome
Title Change From Baseline in Day Time Drowsiness Evaluation Score at Day 7, 14, 28, 42 and Final Evaluation (Day 42 or Early Discontinuation)
Hide Description The day time drowsiness evaluation scale is a self-administered scale that rates day time drowsiness. Participants indicate on an 11-point scale that how often they have felt drowsy within the previous 7 days, score ranged from 0 (not at all) to 10 (all the time). Final evaluation is the last post-baseline visit with data.
Time Frame Baseline, Day 7, 14, 28, 42 and Final Evaluation (Day 42 or early discontinuation)
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population included all participants who received at least 1 dose of paliperidone ER and provided at least 1 post-baseline efficacy measurement. “N” (number of participants analyzed) signifies those participants who were evaluable for this measure and “n" signifies those participants who were evaluated for this measure at given time points.
Arm/Group Title Paliperidone Extended Release (ER)
Hide Arm/Group Description:
Paliperidone ER tablet in flexible daily dose of 3, 6, 9 or 12 milligram (mg) as per Investigators’ discretion was given once daily orally for 6 weeks in the core treatment phase and no longer than 12 months in the extension phase after the completion of core treatment phase.
Overall Number of Participants Analyzed 286
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Baseline (n=286) 3.4  (2.7)
Change at Day 7 (n=280) -0.5  (2.5)
Change at Day 14 (n=273) -1.0  (2.6)
Change at Day 28 (n=250) -1.4  (2.7)
Change at Day 42 (n=234) -1.6  (2.6)
Change at Final Evaluation (n=286) -1.4  (2.7)
9.Secondary Outcome
Title Number of Participants Satisfied With the Study Treatment
Hide Description Treatment satisfaction with paliperidone ER was assessed by the Investigator and participant on a 5-point scale: 1 (very good), 2 (good), 3 (reasonable), 4 (moderate) and 5 (poor), at the end of the core treatment phase (which is, Day 42 or early discontinuation) by conducting an interview.
Time Frame Day 42 or early discontinuation
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population included all participants who received at least 1 dose of paliperidone ER and provided at least 1 post-baseline efficacy measurement. “N” (number of participants analyzed) signifies those participants who were evaluable for this measure at given time point.
Arm/Group Title Paliperidone Extended Release (ER)
Hide Arm/Group Description:
Paliperidone ER tablet in flexible daily dose of 3, 6, 9 or 12 milligram (mg) as per Investigators’ discretion was given once daily orally for 6 weeks in the core treatment phase and no longer than 12 months in the extension phase after the completion of core treatment phase.
Overall Number of Participants Analyzed 268
Measure Type: Number
Unit of Measure: Participants
Treatment efficacy: Very good 66
Treatment efficacy: Good 111
Treatment efficacy: Reasonable 53
Treatment efficacy: Moderate 25
Treatment efficacy: Poor 13
Treatment tolerability: Very good 84
Treatment tolerability: Good 124
Treatment tolerability: Reasonable 35
Treatment tolerability: Moderate 15
Treatment tolerability: Poor 10
10.Other Pre-specified Outcome
Title Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Score at Day 7, 14, 42 and Final Evaluation (Day 42 or Early Discontinuation)
Hide Description The AIMS is a 12-item scale to provide a numeric measure to the observed abnormal movements in different parts of the body. Information is collected after a brief neurological examination and is scored on a 5-point scale (0=none and 4=severe). Final evaluation is the last post-baseline visit with data.
Time Frame Baseline, Day 7, 14, 42 and Final Evaluation (Day 42 or early discontinuation)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all participants who received at least 1 dose of paliperidone ER and had at least 1 post-baseline safety assessment. “N” (number of participants analyzed) signifies those participants who were evaluable for this measure and “n" signifies those participants who were evaluated for this measure at given time points.
Arm/Group Title Paliperidone Extended Release (ER)
Hide Arm/Group Description:
Paliperidone ER tablet in flexible daily dose of 3, 6, 9 or 12 milligram (mg) as per Investigators’ discretion was given once daily orally for 6 weeks in the core treatment phase and no longer than 12 months in the extension phase after the completion of core treatment phase.
Overall Number of Participants Analyzed 290
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Baseline (n=290) 0.59  (2.0)
Change at Day 7 (n=287) -0.05  (1.2)
Change at Day 14 (n=276) -0.13  (1.3)
Change at Day 42 (n=234) -0.18  (1.7)
Change at Final Evaluation (n=290) -0.09  (1.8)
11.Other Pre-specified Outcome
Title Change From Baseline in Simpson Angus Extrapyramidal Symptoms Rating Scale (SAS) Score at Day 7, 14, 42 and Final Evaluation (Day 42 or Early Discontinuation)
Hide Description The SAS is a 10-item scale used to measure the symptoms of parkinsonism (slow movements) or parkinsonian side-effects related to the use of antipsychotic medications. The SAS rates 10 items (including gait, arm dropping, shoulder shaking, elbow rigidity, wrist rigidity, leg pendulousness, head dropping, Glabella tap, tremor and salivation), score ranging from 0 (normal) to 4 (extreme). The SAS global score is the average score (total sum of items score divided by the number of items) and ranges between 0 and 4, where the higher score indicates more severe condition of Extrapyramidal Symptoms. Final evaluation is the last post- baseline visit with data.
Time Frame Baseline, Day 7, 14, 42 and Final Evaluation (Day 42 or early discontinuation)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all participants who received at least 1 dose of paliperidone ER and had at least 1 post-baseline safety assessment. “N” (number of participants analyzed) signifies those participants who were evaluable for this measure and “n" signifies those participants who were evaluated for this measure at given time points.
Arm/Group Title Paliperidone Extended Release (ER)
Hide Arm/Group Description:
Paliperidone ER tablet in flexible daily dose of 3, 6, 9 or 12 milligram (mg) as per Investigators’ discretion was given once daily orally for 6 weeks in the core treatment phase and no longer than 12 months in the extension phase after the completion of core treatment phase.
Overall Number of Participants Analyzed 290
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Baseline (n=290) 0.16  (0.32)
Change at Day 7 (n=287) 0.00  (0.23)
Change at Day 14 (n=276) -0.00  (0.24)
Change at Day 42 (n=234) -0.02  (0.24)
Change at Final Evaluation (n=290) 0.01  (0.34)
12.Other Pre-specified Outcome
Title Change From Baseline in Global Rating Sub-scale Score Based on Barnes Akathisia Rating Scale (BARS) at Day 7, 14, 42 and Final Evaluation (Day 42 or Early Discontinuation)
Hide Description The BARS included an objective rating (from 0=normal to 3=constantly engaged), two subjective ratings of symptoms of akathisia, namely awareness of restlessness (ranging from 0=absence of inner restlessness to 3=awareness of intense compulsion to move) and reported distress related to restlessness (ranging from 0=no distress to 3=severe), and a global clinical rating of akathisia, ranging from 0 (absent) to 5 (severe). Global rating sub-scale score (that is, global clinical rating of akathisia) was assessed which was scored separately and is the most relevant measure of severity of akathisia. Higher scores indicates worsening akathisia. Final evaluation is the last post-baseline visit with data.
Time Frame Baseline, Day 7, 14, 42 and Final Evaluation (Day 42 or early discontinuation)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all participants who received at least 1 dose of paliperidone ER and had at least 1 post-baseline safety assessment. “N” (number of participants analyzed) signifies those participants who were evaluable for this measure and “n" signifies those participants who were evaluated for this measure at given time points.
Arm/Group Title Paliperidone Extended Release (ER)
Hide Arm/Group Description:
Paliperidone ER tablet in flexible daily dose of 3, 6, 9 or 12 milligram (mg) as per Investigators’ discretion was given once daily orally for 6 weeks in the core treatment phase and no longer than 12 months in the extension phase after the completion of core treatment phase.
Overall Number of Participants Analyzed 290
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Baseline (n=290) 0.17  (0.5)
Change at Day 7 (n=286) -0.02  (0.4)
Change at Day 14 (n=276) -0.01  (0.5)
Change at Day 42 (n=234) -0.03  (0.5)
Change at Final Evaluation (n=290) 0.03  (0.7)
Time Frame 6 weeks in the core treatment phase
Adverse Event Reporting Description

An adverse event is any untoward medical occurrence in a clinical study participant administered with study treatment. It can be any unfavorable

& unintended sign/abnormal finding, symptom, or disease temporally associated with use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.

 
Arm/Group Title Paliperidone Extended Release (ER)
Hide Arm/Group Description Paliperidone ER tablet in flexible daily dose of 3, 6, 9 or 12 milligram (mg) as per Investigators’ discretion was given once daily orally for 6 weeks in the core treatment phase and no longer than 12 months in the extension phase after the completion of core treatment phase.
All-Cause Mortality
Paliperidone Extended Release (ER)
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Paliperidone Extended Release (ER)
Affected / at Risk (%)
Total   23/294 (7.82%) 
Cardiac disorders   
Tachycardia * 1  1/294 (0.34%) 
Gastrointestinal disorders   
Abdominal pain * 1  1/294 (0.34%) 
General disorders   
Pyrexia * 1  1/294 (0.34%) 
Injury, poisoning and procedural complications   
Alcohol poisoning * 1  1/294 (0.34%) 
Nervous system disorders   
Extrapyramidal disorder * 1  2/294 (0.68%) 
Mental impairment * 1  1/294 (0.34%) 
Psychiatric disorders   
Acute psychosis * 1  1/294 (0.34%) 
Anxiety * 1  2/294 (0.68%) 
Depression * 1  1/294 (0.34%) 
Insomnia * 1  1/294 (0.34%) 
Intentional self-injury * 1  1/294 (0.34%) 
Major depression * 1  1/294 (0.34%) 
Schizophrenia * 1  12/294 (4.08%) 
Respiratory, thoracic and mediastinal disorders   
Asthma * 1  1/294 (0.34%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA Version 12.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 3%
Paliperidone Extended Release (ER)
Affected / at Risk (%)
Total   150/294 (51.02%) 
Cardiac disorders   
Tachycardia * 1  25/294 (8.50%) 
Gastrointestinal disorders   
Constipation * 1  9/294 (3.06%) 
Infections and infestations   
Nasopharyngitis * 1  13/294 (4.42%) 
Nervous system disorders   
Akathisia * 1  13/294 (4.42%) 
Extrapyramidal disorder * 1  18/294 (6.12%) 
Headache * 1  22/294 (7.48%) 
Psychiatric disorders   
Agitation * 1  10/294 (3.40%) 
Anxiety * 1  14/294 (4.76%) 
Insomnia * 1  68/294 (23.13%) 
Restlessness * 1  10/294 (3.40%) 
Sleep disorder * 1  9/294 (3.06%) 
Vascular disorders   
Hypertension * 1  13/294 (4.42%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA Version 12.0
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.
Results Point of Contact
Name/Title: EMEA Therapeutic Area Leader CNS
Organization: Janssen-Cilag Germany
Phone: +492137955153
Responsible Party: Janssen-Cilag International NV
ClinicalTrials.gov Identifier: NCT00566631     History of Changes
Other Study ID Numbers: CR013162
R076477SCH3018
First Submitted: November 29, 2007
First Posted: December 3, 2007
Results First Submitted: April 3, 2013
Results First Posted: August 2, 2013
Last Update Posted: August 2, 2013