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Symptomatic Remission and Social Function in Participants Treated With Paliperidone Extended Release (ER)

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ClinicalTrials.gov Identifier: NCT01577186
Recruitment Status : Completed
First Posted : April 13, 2012
Results First Posted : January 17, 2014
Last Update Posted : January 17, 2014
Sponsor:
Information provided by (Responsible Party):
Johnson & Johnson Taiwan Ltd

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Schizophrenia
Intervention Drug: Paliperidone ER
Enrollment 480
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Paliperidone ER
Hide Arm/Group Description Participants received paliperidone ER tablet in flexible dose range of 3 to 12 milligram per day orally once daily up to Week 12 as per Investigator’s discretion.
Period Title: Overall Study
Started 480
Completed 350
Not Completed 130
Reason Not Completed
Adverse Event             23
Death             1
Lost to Follow-up             28
Withdrawal by Subject             35
Insufficient Response             18
Ineligible to Continue             15
Non-Compliant             8
Other             2
Arm/Group Title Paliperidone ER
Hide Arm/Group Description Participants received paliperidone ER tablet in flexible dose range of 3 to 12 milligram per day orally once daily up to Week 12 as per Investigator’s discretion.
Overall Number of Baseline Participants 480
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 480 participants
40.3  (10.62)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 480 participants
Female
218
  45.4%
Male
262
  54.6%
1.Primary Outcome
Title Percentage of Participants Achieving Symptomatic Remission by Means of Positive and Negative Syndrome Scale (PANSS)
Hide Description The PANSS is a 30-item scale to assess the neuropsychiatric symptoms of schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self). The PANSS provides a total score and scores for 3 subscales, the positive subscale (7 items), the negative subscale (7 items), and the general psychopathology subscale (16 items), each item scored on a scale of 1 (absent), 2 (minimal), 3 (mild), 4 (moderate), 5 (moderately severe), 6 (severe) and 7 (extreme). The total score ranges from 30 to 210 and higher score indicates greater severity. Symptomatic remission was defined as achieving intensity level of mild or moderate on PANSS scale by all 8 items as the determinants for symptomatic remission: delusions, unusual thought content, hallucinatory behavior, conceptual disorganization, mannerisms/posturing, blunted affect, social withdrawal, lack of spontaneity.
Time Frame End of study (Up to Week 12)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT) population included all participants who received at least 1 dose of study drug and had at least one post-baseline assessment.
Arm/Group Title Paliperidone Extended Release (ER)
Hide Arm/Group Description:
Participants received paliperidone ER tablet in flexible dose range of 3 to 12 milligram per day orally once daily up to Week 12.as per Investigator’s discretion.
Overall Number of Participants Analyzed 426
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
11.74
(8.84 to 15.18)
2.Primary Outcome
Title Percentage of Participants Achieving Improvement in Personal and Social Performance (PSP) Score by at Least One Category on PSP Scale
Hide Description The PSP is 100-point validated clinician-rated scale that assesses degree of difficulty in 4 areas of functioning: socially useful activities, personal and social relationships, self-care, disturbing and aggressive behaviors rated on 6-point scale (1=absent to 6=very severe).Total transformed score from 1 to 100 is generated from raw score based on clinical interpretation of scores generated in 4 areas of functioning, with higher transformed score indicating better function. Total score is divided into 3 levels: 71-100 (mild difficulty); 31-70 (marked difficulty) and 1-30 (severe difficulty). Percentage of participants achieving improvement in PSP score by at least one category was reported.
Time Frame End of study (Up to Week 12)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants who received at least 1 dose of study drug and had at least one post-baseline assessment.
Arm/Group Title Paliperidone Extended Release (ER)
Hide Arm/Group Description:
Participants received paliperidone ER tablet in flexible dose range of 3 to 12 milligram per day orally once daily up to Week 12.as per Investigator’s discretion.
Overall Number of Participants Analyzed 426
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
47.42
(42.59 to 52.28)
3.Secondary Outcome
Title Social Functioning Scale (SFS) Score
Hide Description The SFS is a 36-item scale designed to assess social functioning in schizophrenia. It assesses abilities and performance in seven areas: social engagement, interpersonal communication, activities of daily living, recreation, social activities, competence at independent living, and occupation/employment. Total score ranges from 1 to 100 where higher score indicates a more favorable health state.
Time Frame End of study (Up to Week 12)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants who received at least 1 dose of study drug and had at least one post-baseline assessment. Here 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.
Arm/Group Title Paliperidone Extended Release (ER)
Hide Arm/Group Description:
Participants received paliperidone ER tablet in flexible dose range of 3 to 12 milligram per day orally once daily up to Week 12.as per Investigator’s discretion.
Overall Number of Participants Analyzed 374
Mean (Standard Deviation)
Unit of Measure: units on a scale
44.99  (19.05)
4.Other Pre-specified Outcome
Title Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 12
Hide Description The PANSS is a 30-item scale to assess the neuropsychiatric symptoms of schizophrenia. The PANSS provides a total score and scores for 3 subscales, the positive subscale (7 items), the negative subscale (7 items), and the general psychopathology subscale (16 items), each item scored on a scale of 1 (absent) to 7 (extreme). The total score ranges from 30 to 210 and higher score indicates greater severity.
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants who received at least 1 dose of study drug and had at least one post-baseline assessment. Here, 'n' signifies those participants who were evaluable for this outcome measure at specified time point.
Arm/Group Title Paliperidone Extended Release (ER)
Hide Arm/Group Description:
Participants received paliperidone ER tablet in flexible dose range of 3 to 12 milligram per day orally once daily up to Week 12.as per Investigator’s discretion.
Overall Number of Participants Analyzed 426
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline (n=426) 89.88  (29.60)
Change at Week 12 (n=350) -16.07  (19.64)
5.Other Pre-specified Outcome
Title Change From Baseline in Total Personal and Social Performance (PSP) Score at Week 12
Hide Description The PSP is 100-point validated clinician-rated scale that assesses degree of difficulty in 4 areas of functioning: socially useful activities, personal and social relationships, self-care, disturbing and aggressive behaviors rated on 6-point scale (1=absent to 6=very severe).Total transformed score from 1 to 100 is generated from raw score based on clinical interpretation of scores generated in 4 areas of functioning, with higher transformed score indicating better function. Total score is divided into 3 levels: 71-100 (mild difficulty); 31-70 (marked difficulty) and 1-30 (severe difficulty).
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants who received at least 1 dose of study drug and had at least one post-baseline assessment. Here, 'n' signifies those participants who were evaluable for this outcome measure at specified time point.
Arm/Group Title Paliperidone Extended Release (ER)
Hide Arm/Group Description:
Participants received paliperidone ER tablet in flexible dose range of 3 to 12 milligram per day orally once daily up to Week 12.as per Investigator’s discretion.
Overall Number of Participants Analyzed 426
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline (n=426) 47.07  (16.34)
Change at Week 12 (n=350) 9.05  (12.55)
Time Frame 12 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Paliperidone ER
Hide Arm/Group Description Participants received paliperidone ER tablet in flexible dose range of 3 to 12 milligram per day orally once daily up to Week 12 as per Investigator’s discretion.
All-Cause Mortality
Paliperidone ER
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Paliperidone ER
Affected / at Risk (%)
Total   37/480 (7.71%) 
Cardiac disorders   
Supraventricular Tachycardia * 1  1/480 (0.21%) 
Infections and infestations   
Pulmonary Tuberculosis * 1  1/480 (0.21%) 
Injury, poisoning and procedural complications   
Femur Fracture * 1  1/480 (0.21%) 
Psychiatric disorders   
Aggression * 1  1/480 (0.21%) 
Alcohol Abuse * 1  1/480 (0.21%) 
Completed Suicide * 1  1/480 (0.21%) 
Drug Abuse * 1  1/480 (0.21%) 
Hallucination, Auditory * 1  2/480 (0.42%) 
Impulsive Behaviour * 1  1/480 (0.21%) 
Insomnia * 1  1/480 (0.21%) 
Major Depression * 1  1/480 (0.21%) 
Schizophrenia * 1  27/480 (5.63%) 
Suicide Attempt * 1  1/480 (0.21%) 
Reproductive system and breast disorders   
Scrotal Ulcer * 1  1/480 (0.21%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA Version 12.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
Paliperidone ER
Affected / at Risk (%)
Total   169/480 (35.21%) 
Gastrointestinal disorders   
Constipation * 1  15/480 (3.13%) 
Infections and infestations   
Nasopharyngitis * 1  11/480 (2.29%) 
Upper Respiratory Tract Infection * 1  32/480 (6.67%) 
Investigations   
Weight Increased * 1  14/480 (2.92%) 
Nervous system disorders   
Dizziness * 1  20/480 (4.17%) 
Extrapyramidal Disorder * 1  56/480 (11.67%) 
Headache * 1  10/480 (2.08%) 
Somnolence * 1  10/480 (2.08%) 
Tremor * 1  23/480 (4.79%) 
Psychiatric disorders   
Anxiety * 1  12/480 (2.50%) 
Insomnia * 1  21/480 (4.38%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA Version 12.1
Some Adverse Events summaries were reported based on estimates due to the fact that they were not prepared in the original study report and the relevant definitions of the data elements were not available for these summaries to be regenerated.
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: Medical Director
Organization: Janssen Research & Development
Phone: 886 2 23762155
Responsible Party: Johnson & Johnson Taiwan Ltd
ClinicalTrials.gov Identifier: NCT01577186     History of Changes
Other Study ID Numbers: CR015667
R076477SCH4035 ( Other Identifier: Johnson & Johnson Taiwan Ltd )
PAL-TWN-MA3 ( Other Identifier: Johnson & Johnson Taiwan Ltd )
First Submitted: April 12, 2012
First Posted: April 13, 2012
Results First Submitted: December 2, 2013
Results First Posted: January 17, 2014
Last Update Posted: January 17, 2014