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A Trial to Explore the Tolerability, Safety and Efficacy of Paliperidone Extended Release in Patients With Schizophrenia

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ClinicalTrials.gov Identifier: NCT01606228
Recruitment Status : Completed
First Posted : May 25, 2012
Results First Posted : October 22, 2012
Last Update Posted : October 22, 2012
Sponsor:
Information provided by:
Janssen Pharmaceutica

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Schizophrenia
Intervention Drug: Paliperidone ER
Enrollment 188
Recruitment Details  
Pre-assignment Details There were 188 patients enrolled in the study which were included in the safety analysis set. The main analysis set included only 176 subjects due to 12 protocol violations. Of these 176 patients, only 73 were included in the per-protocol analysis set. For the Clinical Global Impression-Severity scores, data was collected for only 60 patients.
Arm/Group Title Paliperidone Extended-release (ER)
Hide Arm/Group Description Paliperidone ER 6 mg orally administered once daily for the first five days. Thereafter, flexible dosing in a range of 3 to 12 mg/day.
Period Title: Overall Study
Started 188
Completed 159
Not Completed 29
Reason Not Completed
Lost to Follow-up             20
Withdrawal by Subject             3
Non-compliant             3
Lack of Efficacy             2
Adverse Event             1
Arm/Group Title Paliperidone Extended-release (ER)
Hide Arm/Group Description Paliperidone ER 6 mg orally administered once daily for the first five days. Thereafter, flexible dosing in a range of 3 to 12 mg/day.
Overall Number of Baseline Participants 176
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 176 participants
33.71  (9.743)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 176 participants
Female
70
  39.8%
Male
106
  60.2%
1.Primary Outcome
Title The Proportion of Patients Improving 20% in Total Positive and Negative Syndrome Scale (PANSS) at Endpoint (Day 90)
Hide Description The PANSS is a 30-item scale (range 30-210) 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. Higher scores indicate worsening.
Time Frame Baseline, Day 90
Hide Outcome Measure Data
Hide Analysis Population Description
Per Protocol (PP) population
Arm/Group Title Paliperidone Extended-release (ER)
Hide Arm/Group Description:
Paliperidone ER 6 mg orally administered once daily for the first five days. Thereafter, flexible dosing in a range of 3 to 12 mg/day.
Overall Number of Participants Analyzed 73
Measure Type: Number
Unit of Measure: percentage of patients
97.73
2.Secondary Outcome
Title Positive and Negative Syndrome Scale (PANSS) Scores at Baseline
Hide Description The PANSS is a 30-item scale (range 30-210) 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. Higher scores indicate worsening.
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
Per Protocol (PP) population
Arm/Group Title Paliperidone Extended-release (ER)
Hide Arm/Group Description:
Paliperidone ER 6 mg orally administered once daily for the first five days. Thereafter, flexible dosing in a range of 3 to 12 mg/day.
Overall Number of Participants Analyzed 73
Mean (Standard Deviation)
Unit of Measure: scores on a scale
108.25  (23.897)
3.Secondary Outcome
Title Positive and Negative Syndrome Scale (PANSS) Scores at Day 90
Hide Description The PANSS is a 30-item scale (range 30-210) 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. Higher scores indicate worsening.
Time Frame Day 90
Hide Outcome Measure Data
Hide Analysis Population Description
Per Protocol (PP) population
Arm/Group Title Paliperidone Extended-release (ER)
Hide Arm/Group Description:
Paliperidone ER 6 mg orally administered once daily for the first five days. Thereafter, flexible dosing in a range of 3 to 12 mg/day.
Overall Number of Participants Analyzed 73
Mean (Standard Deviation)
Unit of Measure: scores on a scale
48.74  (18.371)
4.Secondary Outcome
Title Clinical Global Impression-Severity (CGIS) Scores at Baseline
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 patient. The rating varies from "Normal (not at all ill)" to "Extreme (among the most extremely ill patients)".
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
Per Protocol (PP) population; participants for whom CGIS data was collected.
Arm/Group Title Paliperidone Extended-release (ER)
Hide Arm/Group Description:
Paliperidone ER 6 mg orally administered once daily for the first five days. Thereafter, flexible dosing in a range of 3 to 12 mg/day.
Overall Number of Participants Analyzed 60
Measure Type: Number
Unit of Measure: participants
Normal 0
Borderline 0
Mild 0
Moderate 11
Marked 33
Severe 14
Extreme 2
5.Secondary Outcome
Title Clinical Global Impression-Severity (CGIS) Scores at Day 90
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 patient. The rating varies from "Normal (not at all ill)" to "Extreme (among the most extremely ill patients)".
Time Frame Day 90
Hide Outcome Measure Data
Hide Analysis Population Description
Per Protocol (PP) population
Arm/Group Title Paliperidone Extended-release (ER)
Hide Arm/Group Description:
Paliperidone ER 6 mg orally administered once daily for the first five days. Thereafter, flexible dosing in a range of 3 to 12 mg/day.
Overall Number of Participants Analyzed 60
Measure Type: Number
Unit of Measure: participants
Normal 0
Borderline 31
Mild 20
Moderate 8
Marked 1
Severe 0
Extreme 0
6.Secondary Outcome
Title Personal and Social Performance (PSP) Scores at Baseline
Hide Description This PSP assesses the degree of a patient'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 (i, absent to vi, very severe) in each of the 4 domains. Based on the four domains there will be one total score. Patients 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
Hide Outcome Measure Data
Hide Analysis Population Description
Per Protocol (PP) population
Arm/Group Title Paliperidone Extended-release (ER)
Hide Arm/Group Description:
Paliperidone ER 6 mg orally administered once daily for the first five days. Thereafter, flexible dosing in a range of 3 to 12 mg/day.
Overall Number of Participants Analyzed 73
Mean (Standard Deviation)
Unit of Measure: scores on a scale
37.23  (12.675)
7.Secondary Outcome
Title Personal and Social Performance (PSP) Scores at Day 90
Hide Description This PSP assesses the degree of a patient'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 (i, absent to vi, very severe) in each of the 4 domains. Based on the four domains there will be one total score. Patients 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 Day 90
Hide Outcome Measure Data
Hide Analysis Population Description
Per Protocol (PP) population
Arm/Group Title Paliperidone Extended-release (ER)
Hide Arm/Group Description:
Paliperidone ER 6 mg orally administered once daily for the first five days. Thereafter, flexible dosing in a range of 3 to 12 mg/day.
Overall Number of Participants Analyzed 73
Mean (Standard Deviation)
Unit of Measure: scores on a scale
75.66  (10.451)
8.Secondary Outcome
Title Patient Satisfaction With Paliperidone Treatment
Hide Description Patients will be interviewed to assess their satisfaction with the current treatment on a 5-point scale (very good, good, reasonable, moderate or poor).
Time Frame 90 days
Hide Outcome Measure Data
Hide Analysis Population Description
Per Protocol (PP) population
Arm/Group Title Paliperidone Extended-release (ER)
Hide Arm/Group Description:
Paliperidone ER 6 mg orally administered once daily for the first five days. Thereafter, flexible dosing in a range of 3 to 12 mg/day.
Overall Number of Participants Analyzed 73
Measure Type: Number
Unit of Measure: participants
Very good 33
Good 34
Moderate 4
Poor 1
Very poor 1
9.Secondary Outcome
Title Quality of Sleep at Baseline
Hide Description The quality of sleep is measured by a self-administered scale in which patients indicate how well they have slept in the previous 7 days, from 0 (very badly) to 100 (very well).
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
Per Protocol (PP) population
Arm/Group Title Paliperidone Extended-release (ER)
Hide Arm/Group Description:
Paliperidone ER 6 mg orally administered once daily for the first five days. Thereafter, flexible dosing in a range of 3 to 12 mg/day.
Overall Number of Participants Analyzed 73
Mean (Standard Deviation)
Unit of Measure: scores on a scale
33.99  (30.091)
10.Secondary Outcome
Title Quality of Sleep at Day 90
Hide Description The quality of sleep is measured by a self-administered scale in which patients indicate how well they have slept in the previous 7 days, from 0 (very badly) to 100 (very well).
Time Frame Day 90
Hide Outcome Measure Data
Hide Analysis Population Description
Per Protocol (PP) population
Arm/Group Title Paliperidone Extended-release (ER)
Hide Arm/Group Description:
Paliperidone ER 6 mg orally administered once daily for the first five days. Thereafter, flexible dosing in a range of 3 to 12 mg/day.
Overall Number of Participants Analyzed 73
Mean (Standard Deviation)
Unit of Measure: scores on a scale
86.56  (18.684)
11.Secondary Outcome
Title Daytime Drowsiness at Baseline
Hide Description The daytime drowsiness is measured by a self-administered scale in which patients indicate how often they have felt drowsy within the previous 7 days, from 0 (not at all) to 100 (all the time).
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
Per Protocol (PP) population
Arm/Group Title Paliperidone Extended-release (ER)
Hide Arm/Group Description:
Paliperidone ER 6 mg orally administered once daily for the first five days. Thereafter, flexible dosing in a range of 3 to 12 mg/day.
Overall Number of Participants Analyzed 73
Mean (Standard Deviation)
Unit of Measure: scores on a scale
21.49  (22.511)
12.Secondary Outcome
Title Daytime Drowsiness at Day 90
Hide Description The daytime drowsiness is measured by a self-administered scale in which patients indicate how often they have felt drowsy within the previous 7 days, from 0 (not at all) to 100 (all the time).
Time Frame Day 90
Hide Outcome Measure Data
Hide Analysis Population Description
Per Protocol (PP) population
Arm/Group Title Paliperidone Extended-release (ER)
Hide Arm/Group Description:
Paliperidone ER 6 mg orally administered once daily for the first five days. Thereafter, flexible dosing in a range of 3 to 12 mg/day.
Overall Number of Participants Analyzed 73
Mean (Standard Deviation)
Unit of Measure: scores on a scale
11.23  (19.061)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Paliperidone Extended-release (ER)
Hide Arm/Group Description Paliperidone ER 6 mg orally administered once daily for the first five days. Thereafter, flexible dosing in a range of 3 to 12 mg/day.
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   4/188 (2.13%) 
Cardiac disorders   
Arrhythmia  1/188 (0.53%) 
Ventricular Extrasystoles  1/188 (0.53%) 
Nervous system disorders   
Akathisia  1/188 (0.53%) 
Psychiatric disorders   
Schizophrenia paranoid type  1/188 (0.53%) 
Schizophrenia  2/188 (1.06%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Paliperidone Extended-release (ER)
Affected / at Risk (%)
Total   43/188 (22.87%) 
Eye disorders   
Upward gazing  1/188 (0.53%) 
Gastrointestinal disorders   
Sialorrhea  3/188 (1.60%) 
Constipation  1/188 (0.53%) 
Acute Gastroenteritis  1/188 (0.53%) 
General disorders   
Pyrexia  3/188 (1.60%) 
Breast pain  2/188 (1.06%) 
Swelling of arm  1/188 (0.53%) 
Sore throat  1/188 (0.53%) 
Infections and infestations   
Otitis media  2/188 (1.06%) 
Urinary Tract Infection  2/188 (1.06%) 
Fungal infection  2/188 (1.06%) 
Upper Respiratory Tract Infection  2/188 (1.06%) 
Pharyngitis  1/188 (0.53%) 
Scabies  1/188 (0.53%) 
Pulmonary Tuberculosis  1/188 (0.53%) 
Metabolism and nutrition disorders   
Anemia  9/188 (4.79%) 
Poor appetite  3/188 (1.60%) 
Diabetes  1/188 (0.53%) 
Hypokalemia  1/188 (0.53%) 
Musculoskeletal and connective tissue disorders   
Back pain  1/188 (0.53%) 
Sprain  1/188 (0.53%) 
Nervous system disorders   
Extra-Pyramidal Symptoms  3/188 (1.60%) 
Akathisia  3/188 (1.60%) 
Restlessness  2/188 (1.06%) 
Dizziness/Vertigo  1/188 (0.53%) 
Headache  1/188 (0.53%) 
Tremors  1/188 (0.53%) 
Dystonia  1/188 (0.53%) 
Psychiatric disorders   
Insomnia  25/188 (13.30%) 
Acute psychotic symptoms  3/188 (1.60%) 
Disturbed behavior  3/188 (1.60%) 
Manic-like behavior  1/188 (0.53%) 
Delusions  1/188 (0.53%) 
Renal and urinary disorders   
Renal Insufficiency  1/188 (0.53%) 
Respiratory, thoracic and mediastinal disorders   
Cough  2/188 (1.06%) 
Colds/nasal congestion  1/188 (0.53%) 
Skin and subcutaneous tissue disorders   
Pruritus  1/188 (0.53%) 
Skin allergy  1/188 (0.53%) 
Eczematous lesion  1/188 (0.53%) 
Social circumstances   
Verbal assault  2/188 (1.06%) 
Vascular disorders   
Hypertension  3/188 (1.60%) 
Orthostatic hypotension  1/188 (0.53%) 
External Hemorrhoid  1/188 (0.53%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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 Affairs Director, CNS, Asia Pacific
Organization: Janssen China
Phone: 8610 5821 8766
Responsible Party: Medical Director, Jan-Cil Philippines
ClinicalTrials.gov Identifier: NCT01606228     History of Changes
Other Study ID Numbers: CR014452
R076477SCH3033 ( Other Identifier: Janssen Pharmaceutica )
PAL-PHL-MA3 ( Other Identifier: Janssen Pharmaceutica )
First Submitted: May 16, 2012
First Posted: May 25, 2012
Results First Submitted: August 3, 2012
Results First Posted: October 22, 2012
Last Update Posted: October 22, 2012