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A Study of Flexibly Dosed Paliperidone Extended Release Tablets in Participants With Schizophrenia

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ClinicalTrials.gov Identifier: NCT01541371
Recruitment Status : Completed
First Posted : February 29, 2012
Results First Posted : August 7, 2013
Last Update Posted : August 7, 2013
Sponsor:
Information provided by (Responsible Party):
Xian-Janssen Pharmaceutical 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 405
Recruitment Details Participants were recruited from 19 study centers between 30 July 2008 and 23 September 2009.
Pre-assignment Details 405 participants were enrolled, out of which 403 participants were recruited in Safety Analysis Set (randomized and took at least 1 dose of study drug) and 394 subjects were included in full analysis set (had at least 1 efficacy evaluation).
Arm/Group Title Paliperidone Extended Release (ER)
Hide Arm/Group Description Paliperidone ER 3 milligram (mg) or 6 mg or 9 mg or 12 mg oral (by mouth) tablets depending on Investigator’s discretion once daily for 12 weeks.
Period Title: Overall Study
Started 403
Full Analysis Set 394
Completed 326
Not Completed 77
Reason Not Completed
Withdrawal by Subject             14
Lost to Follow-up             21
Adverse Event             15
Lack of Efficacy             12
Protocol Violation             6
Study medication non-compliance             3
Other             6
Arm/Group Title Paliperidone Extended Release (ER)
Hide Arm/Group Description Paliperidone ER 3 milligram (mg) or 6 mg or 9 mg or 12 mg oral tablets depending on Investigator’s discretion once daily for 12 weeks.
Overall Number of Baseline Participants 394
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 394 participants
30.88  (10.39)
[1]
Measure Description: Information for demographics (age) was missing for 2 participants.
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 394 participants
Female
199
  50.5%
Male
195
  49.5%
1.Primary Outcome
Title Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 12
Hide Description PANSS is a medical scale that assesses various symptoms of schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions [a false belief held in the face of strong differing evidence, especially as a symptom of psychiatric disorder] and hallucinations [imagining things], and withdrawal into the self). The symptoms are rated on a 7-point scale from 1 (absent) to 7 (extreme psychopathology). The total score is the sum of all 30 PANSS items, with a range of 30 (absent) to 210 (extreme ill).
Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS) included all participants who received at least 1 dose of study medication and had at least 1 post baseline efficacy measurement.
Arm/Group Title Lack of Efficacy Group Lack of Tolerability Group Other Group
Hide Arm/Group Description:
Paliperidone extended release (ER) tablet in flexible dose of 3, 6, 9 or 12 milligram (mg) as per Investigator’s discretion was given once daily orally for 12 weeks to participants who transitioned to paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy (defined as participants with a baseline total Positive and Negative Syndrome Scale [PANSS] score more than [>] or equal to [=] 70 or >=2 items scoring >=4 in the Positive or Negative Symptom Subscale or >=3 items scoring >=4 in the General Psychopathology Subscale).
Paliperidone ER tablet in flexible dose of 3, 6, 9 or 12 mg as per Investigator’s discretion was given once daily orally for 12 weeks to participants who transitioned to paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability (defined as the presence of clinically relevant side effects with the previous antipsychotic medication).
Paliperidone ER tablet in flexible dose of 3, 6, 9 or 12 mg as per Investigator’s discretion was given once daily orally for 12 weeks to participants who transitioned to paliperidone ER from other oral antipsychotics due to other reasons.
Overall Number of Participants Analyzed 238 115 41
Mean (Standard Deviation)
Unit of Measure: unit on a scale
Baseline 77.18  (17.50) 58.46  (16.31) 63.33  (19.08)
Change at Week 12 -26.29  (20.77) -13.99  (15.74) -20.90  (18.20)
2.Secondary Outcome
Title Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Subscale Scores at Week 12
Hide Description PANSS is a medical scale that assesses various symptoms of schizophrenia. The symptoms are rated on a 7-point scale from 1 (absent) to 7 (extreme psychopathology). The total score is the sum of all 30 PANSS items, with a range of 30 (absent) to 210 (extreme ill). Positive syndrome subscale ranges from 7 to 49, higher change scores indicate worsening. Negative syndrome subscale ranges from 7 to 49, higher change scores indicate worsening. General Psychopathology subscale ranges from 16 to112, higher change scores indicate worsening.
Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all participants who received at least 1 dose of study medication and had at least 1 post baseline efficacy measurement.
Arm/Group Title Paliperidone Extended Release (ER)
Hide Arm/Group Description:
Paliperidone ER 3 milligram (mg) or 6 mg or 9 mg or 12 mg oral tablets depending on Investigator’s discretion once daily for 12 weeks.
Overall Number of Participants Analyzed 394
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Positive: Baseline 17.07  (6.53)
Positive: Change at Week 12 -6.59  (6.30)
Negative: Baseline 18.57  (6.66)
Negative: Change at Week 12 -6.14  (5.99)
General psychopathology: Baseline 34.44  (9.75)
General psychopathology: Change at Week 12 -10.84  (10.21)
3.Secondary Outcome
Title Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Marder Subscale Scores at Week 12
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). Positive symptoms subscale consists of 8 items with total score range of 8-56; negative symptoms subscale and disorganized thoughts subscale, each consists of 7 items with total score range of 7-49, uncontrolled hostility/excitement subscale and anxiety/depression subscale, each consists of 4 items with total score range of 4-28. Higher change score indicates greater severity.
Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all participants who received at least 1 dose of study medication and had at least 1 post baseline efficacy measurement.
Arm/Group Title Paliperidone Extended Release (ER)
Hide Arm/Group Description:
Paliperidone ER 3 milligram (mg) or 6 mg or 9 mg or 12 mg oral tablets depending on Investigator’s discretion once daily for 12 weeks.
Overall Number of Participants Analyzed 394
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Positive symptoms: Baseline 21.61  (7.15)
Positive symptoms: Change at Week 12 -8.16  (7.18)
Negative symptoms: Baseline 19.15  (7.10)
Negative symptoms: Change at Week 12 -6.53  (6.60)
Disorganized thoughts: Baseline 14.13  (4.65)
Disorganized thoughts: Change at Week 12 -4.13  (4.28)
Uncontrolled hostility/excitement: Baseline 7.73  (3.83)
Uncontrolled hostility/excitement:Change at Week12 -2.74  (3.63)
Anxiety/depression: Baseline 7.45  (2.76)
Anxiety/depression: Change at Week 12 -2.00  (2.67)
4.Secondary Outcome
Title Percentage of Participants With Response to Positive and Negative Syndrome Scale (PANSS) Total Score
Hide Description PANSS is a medical scale that assesses various symptoms of schizophrenia. The symptoms are rated on a 7-point scale from 1 (absent) to 7 (extreme psychopathology). The total score is the sum of all 30 PANSS items, with a range of 30 (absent) to 210 (extreme ill). Percentage of participants with at least 20 percent improvement of PANSS total score was measured.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all participants who received at least 1 dose of study medication and had at least 1 post baseline efficacy measurement.
Arm/Group Title Lack of Efficacy Group Lack of Tolerability Group Other Group
Hide Arm/Group Description:
Paliperidone ER tablet in flexible dose of 3, 6, 9 or 12 milligram (mg) as per Investigator’s discretion was given once daily orally for 12 weeks to participants who transitioned to paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy (defined as participants with a baseline total Positive and Negative Syndrome Scale [PANSS] score more than [>] or equal to [=] 70 or >=2 items scoring >=4 in the Positive or Negative Symptom Subscale or >=3 items scoring >=4 in the General Psychopathology Subscale).
Paliperidone ER tablet in flexible dose of 3, 6, 9 or 12 mg as per Investigator’s discretion was given once daily orally for 12 weeks to participants who transitioned to paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability (defined as the presence of clinically relevant side effects with the previous antipsychotic medication).
Paliperidone ER tablet in flexible dose of 3, 6, 9 or 12 mg as per Investigator’s discretion was given once daily orally for 12 weeks to participants who transitioned to paliperidone ER from other oral antipsychotics due to other reasons.
Overall Number of Participants Analyzed 238 115 41
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
65.97
(59.95 to 71.99)
51.72
(42.63 to 60.82)
61.90
(47.22 to 76.59)
5.Secondary Outcome
Title Change From Baseline in Clinical Global Impression-Severity (CGI-S) Score at Week 12
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 change scores indicate worsening.
Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all participants who received at least 1 dose of study medication and had at least 1 post baseline efficacy measurement. Here "N" (Number of Participants Analyzed): number of participants who were evaluable for this measure. ‘n’: number of participants who were evaluable at given time point for each arm group, respectively.
Arm/Group Title Lack of Efficacy Group Lack of Tolerability Group Other Group
Hide Arm/Group Description:
Paliperidone ER tablet in flexible dose of 3, 6, 9 or 12 milligram (mg) as per Investigator’s discretion was given once daily orally for 12 weeks to participants who transitioned to paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy (defined as participants with a baseline total Positive and Negative Syndrome Scale [PANSS] score more than [>] or equal to [=] 70 or >=2 items scoring >=4 in the Positive or Negative Symptom Subscale or >=3 items scoring >=4 in the General Psychopathology Subscale).
Paliperidone ER tablet in flexible dose of 3, 6, 9 or 12 mg as per Investigator’s discretion was given once daily orally for 12 weeks to participants who transitioned to paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability (defined as the presence of clinically relevant side effects with the previous antipsychotic medication).
Paliperidone ER tablet in flexible dose of 3, 6, 9 or 12 mg as per Investigator’s discretion was given once daily orally for 12 weeks to participants who transitioned to paliperidone ER from other oral antipsychotics due to other reasons.
Overall Number of Participants Analyzed 237 115 41
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline (n=237,115,41) 4.54  (0.91) 3.20  (1.11) 3.86  (1.09)
Change at Week 12 (n=208,103,40) -1.77  (0.09) -1.01  (0.14) -1.66  (0.23)
6.Secondary Outcome
Title Change From Baseline in Total Personal and Social Performance (PSP) Score at Week 12
Hide Description PSP assesses the degree of a participant’s dysfunction within 4 domains of behavior: socially useful activities, personal and social relationships, self-care, and 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 the 4 domains. Based on the four domains there will be one total score. Participants with a score of 71 to 100 have a mild degree of difficulty; from 31 to 70, varying degrees of disability; =<30, functioning so poorly as to require intensive supervision.
Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all participants who received at least 1 dose of study medication and had at least 1 post baseline efficacy measurement. Here ‘n’: number of participants who were evaluable at given time point for each arm group, respectively.
Arm/Group Title Lack of Efficacy Group Lack of Tolerability Group Other Group
Hide Arm/Group Description:
Paliperidone ER tablet in flexible dose of 3, 6, 9 or 12 milligram (mg) as per Investigator’s discretion was given once daily orally for 12 weeks to participants who transitioned to paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy (defined as participants with a baseline total Positive and Negative Syndrome Scale [PANSS] score more than [>] or equal to [=] 70 or >=2 items scoring >=4 in the Positive or Negative Symptom Subscale or >=3 items scoring >=4 in the General Psychopathology Subscale).
Paliperidone ER tablet in flexible dose of 3, 6, 9 or 12 mg as per Investigator’s discretion was given once daily orally for 12 weeks to participants who transitioned to paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability (defined as the presence of clinically relevant side effects with the previous antipsychotic medication).
Paliperidone ER tablet in flexible dose of 3, 6, 9 or 12 mg as per Investigator’s discretion was given once daily orally for 12 weeks to participants who transitioned to paliperidone ER from other oral antipsychotics due to other reasons.
Overall Number of Participants Analyzed 238 115 41
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Baseline (n=238,115,41) 53.16  (13.79) 66.95  (12.89) 66.00  (11.21)
Change at Week 12 (n=205,106,40) 18.57  (16.87) 10.09  (13.75) 12.40  (13.33)
7.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: 1 (very good), 2 (good), 3 (moderate), 4 (poor) and 5 (very poor).
Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all participants who received at least 1 dose of study medication and had at least 1 post baseline efficacy measurement. Here "N" (Number of Participants Analyzed): number of participants who were evaluable for this measure. ‘n’: number of participants who were evaluable at given time point for each arm group, respectively.
Arm/Group Title Lack of Efficacy Group Lack of Tolerability Group Other Group
Hide Arm/Group Description:
Paliperidone ER tablet in flexible dose of 3, 6, 9 or 12 milligram (mg) as per Investigator’s discretion was given once daily orally for 12 weeks to participants who transitioned to paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy (defined as participants with a baseline total Positive and Negative Syndrome Scale [PANSS] score more than [>] or equal to [=] 70 or >=2 items scoring >=4 in the Positive or Negative Symptom Subscale or >=3 items scoring >=4 in the General Psychopathology Subscale).
Paliperidone ER tablet in flexible dose of 3, 6, 9 or 12 mg as per Investigator’s discretion was given once daily orally for 12 weeks to participants who transitioned to paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability (defined as the presence of clinically relevant side effects with the previous antipsychotic medication).
Paliperidone ER tablet in flexible dose of 3, 6, 9 or 12 mg as per Investigator’s discretion was given once daily orally for 12 weeks to participants who transitioned to paliperidone ER from other oral antipsychotics due to other reasons.
Overall Number of Participants Analyzed 230 113 41
Measure Type: Number
Unit of Measure: Participants
Baseline, Very satisfied (n=230,113,41) 1 3 0
Baseline, Satisfied (n=230,113,41) 15 30 15
Baseline, Generally satisfied (n=230,113,41) 84 58 25
Baseline, Dissatisfied (n=230,113,41) 124 21 1
Baseline, Very dissatisfied (n=230,113,41) 6 1 0
Week 12, Very satisfied (n=208,105,40) 30 23 10
Week 12, Satisfied (n=208,105,40) 93 51 18
Week 12, Generally satisfied (n=208,105,40) 62 24 10
Week 12, Dissatisfied (n=208,105,40) 23 6 2
Week 12, Very dissatisfied (n=208,105,40) 0 1 0
8.Secondary Outcome
Title Change From Baseline in Sleep and Daytime Drowsiness Evaluation Score at Week 12
Hide Description The self-administered sleep VAS scale (0-100 milimeter [mm]) rates quality of sleep (QoS) and daytime drowsiness (DD). Participants indicate mark on the scale to represent how well they have slept in the previous 7 days, score ranges from 0 mm (very badly) to 100 mm (very well); and how often they have felt drowsy within the previous 7 days, from 0 mm (not at all) to 100 mm (all the time).
Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all participants who received at least 1 dose of study medication and had at least 1 post baseline efficacy measurement. Here "N" (Number of Participants Analyzed): number of participants who were evaluable for this measure. ‘n’: number of participants who were evaluable at given time point for each arm group, respectively.
Arm/Group Title Lack of Efficacy Group Lack of Tolerability Group Other Group
Hide Arm/Group Description:
Paliperidone ER tablet in flexible dose of 3, 6, 9 or 12 milligram (mg) as per Investigator’s discretion was given once daily orally for 12 weeks to participants who transitioned to paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy (defined as participants with a baseline total Positive and Negative Syndrome Scale [PANSS] score more than [>] or equal to [=] 70 or >=2 items scoring >=4 in the Positive or Negative Symptom Subscale or >=3 items scoring >=4 in the General Psychopathology Subscale).
Paliperidone ER tablet in flexible dose of 3, 6, 9 or 12 mg as per Investigator’s discretion was given once daily orally for 12 weeks to participants who transitioned to paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability (defined as the presence of clinically relevant side effects with the previous antipsychotic medication).
Paliperidone ER tablet in flexible dose of 3, 6, 9 or 12 mg as per Investigator’s discretion was given once daily orally for 12 weeks to participants who transitioned to paliperidone ER from other oral antipsychotics due to other reasons.
Overall Number of Participants Analyzed 233 115 41
Mean (Standard Deviation)
Unit of Measure: mm
Quality of sleep score: Baseline (n=233,115,41) 60.76  (26.70) 75.89  (20.24) 70.31  (22.40)
Quality of sleep: Change at Week 12 (n=202,106,40) 15.76  (29.46) 2.90  (27.41) 13.60  (26.94)
Daytime drowsiness score: Baseline (n=233,115,41) 38.16  (23.70) 44.77  (25.29) 34.26  (23.64)
Daytime drowsiness:Change at Week 12(n=202,106,40) -15.76  (27.52) -21.66  (27.88) -18.10  (26.87)
Time Frame Baseline up to Week 12
Adverse Event Reporting Description An undesirable or unwanted consequence that occurs during the course of the clinical trial, but not necessarily because of study drug.
 
Arm/Group Title Paliperidone Extended Release (ER)
Hide Arm/Group Description Paliperidone ER 3 milligram (mg) or 6 mg or 9 mg or 12 mg oral tablets depending on Investigator’s discretion once daily for 12 weeks.
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 (%) # Events
Total   1/403 (0.25%)    
Psychiatric disorders   
Depression * 1  1/403 (0.25%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA Version13.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Paliperidone Extended Release (ER)
Affected / at Risk (%) # Events
Total   227/403 (56.33%)    
Gastrointestinal disorders   
Nausea * 1  15/403 (3.72%)  15
Vomiting * 1  8/403 (1.99%)  8
Salivary hypersecretion * 1  7/403 (1.74%)  8
Constipation * 1  6/403 (1.49%)  6
Diarrhoea * 1  6/403 (1.49%)  6
General disorders   
Fatigue * 1  11/403 (2.73%)  14
Hepatobiliary disorders   
Hepatic function abnormal * 1  6/403 (1.49%)  6
Infections and infestations   
Upper respiratory tract infection * 1  15/403 (3.72%)  16
Investigations   
Weight increased * 1  17/403 (4.22%)  18
Transaminases increased * 1  9/403 (2.23%)  10
Blood prolactin increased * 1  6/403 (1.49%)  7
Metabolism and nutrition disorders   
Obesity * 1  8/403 (1.99%)  8
Increased appetite * 1  6/403 (1.49%)  6
Nervous system disorders   
Tremor * 1  52/403 (12.90%)  56
Dystonia * 1  35/403 (8.68%)  40
Extrapyramidal disorder * 1  24/403 (5.96%)  28
Dizziness * 1  17/403 (4.22%)  20
Headache * 1  7/403 (1.74%)  9
Psychiatric disorders   
Akathisia * 1  74/403 (18.36%)  76
Somnolence * 1  32/403 (7.94%)  33
Insomnia * 1  26/403 (6.45%)  28
Sleep disorder * 1  9/403 (2.23%)  9
Reproductive system and breast disorders   
Menstrual disorders * 1  7/403 (1.74%)  7
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA Version13.0
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: Therapeutic Area Manager
Organization: CDMA, Beijing
Phone: 00861058218352
Responsible Party: Xian-Janssen Pharmaceutical Ltd.
ClinicalTrials.gov Identifier: NCT01541371     History of Changes
Other Study ID Numbers: CR016165
R076477-SCH-3035
First Submitted: February 23, 2012
First Posted: February 29, 2012
Results First Submitted: February 28, 2013
Results First Posted: August 7, 2013
Last Update Posted: August 7, 2013