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An Efficacy, Safety And Tolerability Study of Flexibly Dosed Paliperidone Extended-Release (ER) in Participants With Schizophrenia

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ClinicalTrials.gov Identifier: NCT00757705
Recruitment Status : Completed
First Posted : September 23, 2008
Results First Posted : March 19, 2014
Last Update Posted : March 19, 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 299
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Paliperidone Extended Release (ER)
Hide Arm/Group Description Participants received flexible dose of 3 to 12 milligram (mg) of paliperidone ER once daily orally for 24 weeks. Dose adjustment was done as per Investigator’s discretion based upon participant’s clinical response to and tolerability of the study drug.
Period Title: Overall Study
Started 299
Completed 178
Not Completed 121
Reason Not Completed
Adverse Event             19
Lost to Follow-up             16
Withdrawal by Subject             25
Insufficient Response             26
Ineligible to continue             8
Non-compliant             9
Other             18
Arm/Group Title Paliperidone Extended Release (ER)
Hide Arm/Group Description Participants received flexible dose of 3 to 12 milligram (mg) of paliperidone ER once daily orally for 24 weeks. Dose adjustment was done as per Investigator’s discretion based upon participant’s clinical response to and tolerability of the study drug.
Overall Number of Baseline Participants 299
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 299 participants
40.1  (11.85)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 299 participants
Female
162
  54.2%
Male
137
  45.8%
1.Primary Outcome
Title Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 24
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) to 7 (extreme). The total score ranges from 30 to 210 and higher score indicates greater severity.
Time Frame Baseline, Week 24
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. Missing data was imputed using last observation carried forward (LOCF). 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 flexible dose of 3 to 12 milligram (mg) of paliperidone ER once daily orally for 24 weeks. Dose adjustment was done as per Investigator’s discretion based upon participant’s clinical response to and tolerability of the study drug.
Overall Number of Participants Analyzed 297
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Baseline (n=297) 72.4  (21.1)
Change at Week 24 (n=281) -6.9  (17.3)
2.Secondary Outcome
Title Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Marder Subscale Scores at Week 24
Hide Description The PANSS is a 30-item scale to assess the neuropsychiatric symptoms of schizophrenia. The symptoms are rated on a 7-point scale from 1 (absent) to 7 (extreme psychopathology). Marder PANSS subscales include positive symptoms subscale consisting of 8 items with total score range of 8-56; negative symptoms subscale and disorganized thoughts subscale, each consisting of 7 items with total score range of 7-49; and uncontrolled hostility/excitement (UH/E) subscale and anxiety/depression subscale, each consisting of 4 items with total score range of 4-28. Higher score indicates greater severity.
Time Frame Baseline, Week 24
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. Missing data was imputed using LOCF. 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 flexible dose of 3 to 12 milligram (mg) of paliperidone ER once daily orally for 24 weeks. Dose adjustment was done as per Investigator’s discretion based upon participant’s clinical response to and tolerability of the study drug.
Overall Number of Participants Analyzed 297
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Positive symptoms: Baseline (n=297) 21.6  (7.2)
Positive symptoms:Change at Week 24 (n=281) -2.2  (5.6)
Negative symptoms: Baseline (n=297) 17.0  (7.0)
Negative symptoms:Change at Week 24 (n=281) -1.7  (4.4)
Disorganized thoughts: Baseline (n=297) 16.7  (6.6)
Disorganized thoughts: Change at Week 24 (n=281) -1.4  (4.4)
UH/E: Baseline (n=297) 7.5  (3.3)
UH/E: Change at Week 24 (n=281) -0.5  (3.9)
Anxiety/depression: Baseline (n=297) 9.7  (3.8)
Anxiety/depression:Change at Week 24(n=281) -1.1  (3.5)
3.Secondary Outcome
Title Percentage of Participants With at Least 20 Percent Improvement in Positive and Negative Syndrome Scale (PANSS) Total Score
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) to 7 (extreme). The total score ranges from 30 to 210 and higher score indicates greater severity.
Time Frame Up to Week 24
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 participants evaluable for this measure.
Arm/Group Title Paliperidone Extended Release (ER)
Hide Arm/Group Description:
Participants received flexible dose of 3 to 12 milligram (mg) of paliperidone ER once daily orally for 24 weeks. Dose adjustment was done as per Investigator’s discretion based upon participant’s clinical response to and tolerability of the study drug.
Overall Number of Participants Analyzed 281
Measure Type: Number
Unit of Measure: Percentage of participants
31.3
4.Secondary Outcome
Title Change From Baseline in Total Personal and Social Performance (PSP) Score at Week 24
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 24
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. Missing data was imputed using LOCF. 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 flexible dose of 3 to 12 milligram (mg) of paliperidone ER once daily orally for 24 weeks. Dose adjustment was done as per Investigator’s discretion based upon participant’s clinical response to and tolerability of the study drug.
Overall Number of Participants Analyzed 297
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Baseline (n=297) 54.5  (13.8)
Change at Week 24 (n=269) 3.4  (12.7)
5.Secondary Outcome
Title Change From Baseline in Global Assessment of Functioning (GAF) Score at Week 24
Hide Description The GAF is a 100-point tool rating overall psychological, social and occupational functioning of adults. The higher score range (91-100) refers to a superior functioning in a wide range of activities, and absence of symptoms. The lower score range (1-10) refers to persistent danger of severely hurting self or others; or persistent inability to maintain minimum personal hygiene; or serious suicidal act with clear expectation of death.
Time Frame Baseline, Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population: all participants who received at least 1 dose of study drug and had at least one post-baseline assessment. Missing data was imputed using LOCF. Here 'N' (Number of Participants Analyzed) signifies number of participants who were evaluable for this measure. 'n' signifies those participants who were evaluable at specified time point.
Arm/Group Title Paliperidone Extended Release (ER)
Hide Arm/Group Description:
Participants received flexible dose of 3 to 12 milligram (mg) of paliperidone ER once daily orally for 24 weeks. Dose adjustment was done as per Investigator’s discretion based upon participant’s clinical response to and tolerability of the study drug.
Overall Number of Participants Analyzed 273
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Baseline (n=273) 48.9  (14.7)
Change at Week 24 (n=246) 5.8  (15.2)
6.Secondary Outcome
Title Change From Baseline in Clinical Global Impression-Severity (CGI-S) Score at Week 24
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".
Time Frame Baseline, Week 24
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. Missing data was imputed using LOCF. 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 flexible dose of 3 to 12 milligram (mg) of paliperidone ER once daily orally for 24 weeks. Dose adjustment was done as per Investigator’s discretion based upon participant’s clinical response to and tolerability of the study drug.
Overall Number of Participants Analyzed 297
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Baseline (n=297) 4.3  (1.1)
Change at Week 24 (n=279) -0.5  (1.1)
7.Secondary Outcome
Title Change From Baseline in Short-Form 36 Health Survey (SF-36) Score at Week 24
Hide Description The SF-36 is a health status survey with 36 questions measuring 8 dimensions (physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health) that are subsequently aggregated into 2 summary scales, Physical Component Summary (PCS) and Mental Component Summary (MCS). Each item is scored into on a 0-100 range so that the lowest and highest possible scores are set at 0 and 100, respectively. All items are scored so that a high score defines a more favorable health state.
Time Frame Baseline, Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population: all participants who received at least 1 dose of study drug and had at least one post-baseline assessment. Missing data was imputed using LOCF. Here 'N' (Number of Participants Analyzed) signifies number of participants who were evaluable for this measure. 'n' signifies those participants who were evaluable at specified time point.
Arm/Group Title Paliperidone Extended Release (ER)
Hide Arm/Group Description:
Participants received flexible dose of 3 to 12 milligram (mg) of paliperidone ER once daily orally for 24 weeks. Dose adjustment was done as per Investigator’s discretion based upon participant’s clinical response to and tolerability of the study drug.
Overall Number of Participants Analyzed 295
Mean (Standard Deviation)
Unit of Measure: Units on a scale
PCS: Baseline (n=293) 61.3  (19.8)
PCS: Change at Week 24 (n=225) 0.6  (16.1)
MCS: Baseline (n=295) 53.1  (21.5)
MCS: Change at Week 24 (n=228) 2.0  (18.4)
8.Secondary Outcome
Title Number of Participants With Satisfaction With the Study Treatment
Hide Description Participants assessed their satisfaction with paliperidone ER on a 5-point scale (very good, good, moderate, poor or very poor).
Time Frame Week 24
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 participants evaluable for this measure.
Arm/Group Title Paliperidone Extended Release (ER)
Hide Arm/Group Description:
Participants received flexible dose of 3 to 12 milligram (mg) of paliperidone ER once daily orally for 24 weeks. Dose adjustment was done as per Investigator’s discretion based upon participant’s clinical response to and tolerability of the study drug.
Overall Number of Participants Analyzed 237
Measure Type: Number
Unit of Measure: Participants
Very good 11
Good 83
Moderate 83
Poor 49
Very poor 11
9.Secondary Outcome
Title Change From Baseline in Sleep Quality and Daytime Drowsiness Score at Week 24
Hide Description The Sleep Quality and Daytime Drowsiness evaluation scale is a self-administered scale that rates quality of sleep and daytime drowsiness. Participants indicated on a 5 point scale how well they have slept in the previous 7 days, score ranging from 1 (very badly) to 5 (very well) and how often they have felt drowsy within the previous 7 days, score ranging from 1 (not at all) to 5 (all the time).
Time Frame Baseline, Week 24
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 flexible dose of 3 to 12 milligram (mg) of paliperidone ER once daily orally for 24 weeks. Dose adjustment was done as per Investigator’s discretion based upon participant’s clinical response to and tolerability of the study drug.
Overall Number of Participants Analyzed 297
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Quality of sleep: Baseline (n=297) 3.2  (1.0)
Quality of sleep:Change at Week 24 (n=278) 0.1  (1.1)
Daytime drowsiness: Baseline (n=297) 2.6  (1.0)
Daytime drowsiness:Change at Week 24 (n=278) -0.3  (1.2)
Time Frame Baseline up to Week 24
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Paliperidone Extended Release (ER)
Hide Arm/Group Description Participants received flexible dose of 3 to 12 milligram (mg) of paliperidone ER once daily orally for 24 weeks. Dose adjustment was done as per Investigator’s discretion based upon participant’s clinical response to and tolerability of the study drug.
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   11/299 (3.68%) 
Infections and infestations   
Cellulitis * 1  1/299 (0.33%) 
Injury, poisoning and procedural complications   
Fall * 1  1/299 (0.33%) 
Investigations   
Blood Electrolytes Abnormal * 1  1/299 (0.33%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Hepatic Neoplasm Malignant * 1  1/299 (0.33%) 
Nervous system disorders   
Haemorrhage Intracranial * 1  1/299 (0.33%) 
Pregnancy, puerperium and perinatal conditions   
Pregnancy * 1  1/299 (0.33%) 
Psychiatric disorders   
Delirium * 1  1/299 (0.33%) 
Hallucination, Auditory * 1  1/299 (0.33%) 
Insomnia * 1  1/299 (0.33%) 
Psychotic Disorder * 1  1/299 (0.33%) 
Schizophrenia * 1  1/299 (0.33%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA Version
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
Paliperidone Extended Release (ER)
Affected / at Risk (%)
Total   180/299 (60.20%) 
Cardiac disorders   
Palpitations * 1  6/299 (2.01%) 
Gastrointestinal disorders   
Constipation * 1  29/299 (9.70%) 
Immune system disorders   
Hypersensitivity * 1  6/299 (2.01%) 
Infections and infestations   
Cellulitis * 1  6/299 (2.01%) 
Upper Respiratory Tract Infection * 1  30/299 (10.03%) 
Musculoskeletal and connective tissue disorders   
Arthralgia * 1  6/299 (2.01%) 
Muscle Rigidity * 1  11/299 (3.68%) 
Nervous system disorders   
Akathisia * 1  18/299 (6.02%) 
Bradykinesia * 1  6/299 (2.01%) 
Dizziness * 1  10/299 (3.34%) 
Extrapyramidal Disorder * 1  41/299 (13.71%) 
Headache * 1  14/299 (4.68%) 
Parkinsonism * 1  8/299 (2.68%) 
Sedation * 1  10/299 (3.34%) 
Somnolence * 1  6/299 (2.01%) 
Tremor * 1  15/299 (5.02%) 
Psychiatric disorders   
Agitation * 1  7/299 (2.34%) 
Anxiety * 1  35/299 (11.71%) 
Depression * 1  27/299 (9.03%) 
Hallucination, Auditory * 1  10/299 (3.34%) 
Insomnia * 1  62/299 (20.74%) 
Panic Disorder * 1  7/299 (2.34%) 
Sleep Disorder * 1  8/299 (2.68%) 
Respiratory, thoracic and mediastinal disorders   
Cough * 1  6/299 (2.01%) 
Skin and subcutaneous tissue disorders   
Dermatitis * 1  8/299 (2.68%) 
Dermatitis Contact * 1  6/299 (2.01%) 
Pruritus * 1  8/299 (2.68%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA Version
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: NCT00757705     History of Changes
Other Study ID Numbers: CR014308
R076477SCH4033
First Submitted: September 19, 2008
First Posted: September 23, 2008
Results First Submitted: February 5, 2014
Results First Posted: March 19, 2014
Last Update Posted: March 19, 2014