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Tolerability, Safety and Efficacy of Flexibly Dosed Paliperidone ER in Patients With Schizophrenia (PERFLEX)

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ClinicalTrials.gov Identifier: NCT01724359
Recruitment Status : Completed
First Posted : November 9, 2012
Results First Posted : March 15, 2013
Last Update Posted : March 15, 2013
Sponsor:
Information provided by (Responsible Party):
Janssen-Cilag, S.A.

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Schizophrenia
Intervention Drug: Paliperidone ER
Enrollment 95
Recruitment Details  
Pre-assignment Details Patients who received paliperidone extended-release (ER) at least once and provide at least 1 post baseline efficacy measurement will be included in the intent-to-treat (ITT) analysis set for efficacy. Patients who received paliperidone ER at least once and provide any post-baseline information will be included in the ITT analysis set for safety.
Arm/Group Title Paliperidone Extended-release (ER)
Hide Arm/Group Description The recommended Paliperidone ER dose is 6 mg/day. Some patients may benefit from higher or lower doses, in the range of 3 to 12 mg/day. Paliperidone ER will be administered orally once daily.
Period Title: Overall Study
Started 95
Completed 64
Not Completed 31
Reason Not Completed
Adverse Event             10
Death             1
Not specified             20
Arm/Group Title Paliperidone Extended-release (ER)
Hide Arm/Group Description The recommended Paliperidone ER dose is 6 mg/day. Some patients may benefit from higher or lower doses, in the range of 3 to 12 mg/day. Paliperidone ER will be administered orally once daily.
Overall Number of Baseline Participants 95
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 95 participants
35.86  (12.28)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 95 participants
Female
41
  43.2%
Male
54
  56.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 95 participants
Argentina 37
Colombia 58
1.Primary Outcome
Title Change From Baseline 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. 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.
Time Frame Baseline, Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
All participants of the intent-to-treat analysis set for efficacy with evaluable data at each measurement time point.
Arm/Group Title Paliperidone Extended-release (ER)
Hide Arm/Group Description:
The recommended Paliperidone ER dose is 6 mg/day. Some patients may benefit from higher or lower doses, in the range of 3 to 12 mg/day. Paliperidone ER will be administered orally once daily.
Overall Number of Participants Analyzed 70
Mean (Standard Deviation)
Unit of Measure: scores on a scale
Baseline (n= 70) 83.99  (22.16)
Week 26 (n= 70) 53.70  (18.82)
2.Secondary Outcome
Title Change From Baseline in Total Positive and Negative Syndrome Scale (PANSS) - Positive Subscale Score
Hide Description The PANSS Positive Subscale assesses seven positive-symptoms of schizophrenia. Positive symptoms refer to an excess or distortion of normal functions. The symptoms are rated on a 7-point scale, with a range of 7 (absent) to 49 (extreme psychopathology).
Time Frame Baseline, Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
All participants of the intent-to-treat analysis set for efficacy with evaluable data at each measurement time point.
Arm/Group Title Paliperidone Extended-release (ER)
Hide Arm/Group Description:
The recommended Paliperidone ER dose is 6 mg/day. Some patients may benefit from higher or lower doses, in the range of 3 to 12 mg/day. Paliperidone ER will be administered orally once daily.
Overall Number of Participants Analyzed 70
Mean (Standard Deviation)
Unit of Measure: scores on a scale
Baseline (n= 70) 18.53  (7.30)
Week 26 (n= 70) 11.16  (4.95)
3.Secondary Outcome
Title Change From Baseline in Total Positive and Negative Syndrome Scale (PANSS) - Negative Subscale Score
Hide Description The PANSS Negative Subscale assesses seven negative-symptoms of schizophrenia. Negative symptoms represent a diminution or loss of normal functions. The symptoms are rated on a 7-point scale, with a range of 7 (absent) to 49 (extreme psychopathology).
Time Frame Baseline, Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
All participants of the intent-to-treat analysis set for efficacy with evaluable data at each measurement time point.
Arm/Group Title Paliperidone Extended-release (ER)
Hide Arm/Group Description:
The recommended Paliperidone ER dose is 6 mg/day. Some patients may benefit from higher or lower doses, in the range of 3 to 12 mg/day. Paliperidone ER will be administered orally once daily.
Overall Number of Participants Analyzed 70
Mean (Standard Deviation)
Unit of Measure: scores on a scale
Baseline (n= 70) 23.69  (6.42)
Week 26 (n= 70) 14.64  (5.24)
4.Secondary Outcome
Title Change From Baseline in Total Positive and Negative Syndrome Scale (PANSS) - General Psychopathology Subscale Score
Hide Description The PANSS General Psychopathology Subscale Score assesses 16 general psychopathology symptoms. The symptoms are rated on a 7-point scale, with a range of 16 (absent) to 112 (extreme psychopathology).
Time Frame Baseline, Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
All participants of the intent-to-treat analysis set for efficacy with evaluable data at each measurement time point.
Arm/Group Title Paliperidone Extended-release (ER)
Hide Arm/Group Description:
The recommended Paliperidone ER dose is 6 mg/day. Some patients may benefit from higher or lower doses, in the range of 3 to 12 mg/day. Paliperidone ER will be administered orally once daily.
Overall Number of Participants Analyzed 70
Mean (Standard Deviation)
Unit of Measure: scores on a scale
Baseline (n= 70) 41.77  (11.39)
Week 26 (n= 70) 27.90  (10.34)
5.Secondary Outcome
Title Clinical Global Impression-Severity (CGIS)
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. 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 patients". Higher scores indicate worsening.
Time Frame Baseline, Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
All participants of the intent-to-treat analysis set for efficacy with evaluable data at each measurement time point.
Arm/Group Title Patients at Baseline: Paliperidone Extended-release (ER) Patients at Week 26: Paliperidone Extended-release (ER)
Hide Arm/Group Description:
The recommended Paliperidone ER dose is 6 mg/day. Some patients may benefit from higher or lower doses, in the range of 3 to 12 mg/day. Paliperidone ER will be administered orally once daily.
The recommended Paliperidone ER dose is 6 mg/day. Some patients may benefit from higher or lower doses, in the range of 3 to 12 mg/day. Paliperidone ER will be administered orally once daily.
Overall Number of Participants Analyzed 95 83
Measure Type: Number
Unit of Measure: participants
Normal, not at all ill 2 9
Borderline mentally ill 3 21
Mildly ill 14 26
Moderately ill 39 20
Markedly ill 26 5
Severely ill 10 2
Among the most extremely ill 1 0
6.Secondary Outcome
Title Personal and Social Performance (PSP) Scale
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, Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
All participants of the intent-to-treat analysis set for efficacy with evaluable data at each measurement time point.
Arm/Group Title Paliperidone Extended-release (ER)
Hide Arm/Group Description:
The recommended Paliperidone ER dose is 6 mg/day. Some patients may benefit from higher or lower doses, in the range of 3 to 12 mg/day. Paliperidone ER will be administered orally once daily.
Overall Number of Participants Analyzed 95
Mean (Standard Deviation)
Unit of Measure: scores on a scale
Baseline (n= 95) 52.06  (15.27)
Week 26 (n= 78) 68.24  (15.91)
7.Secondary Outcome
Title Health Status as Measured by Self-rated Health Status Survey SF-36
Hide Description The SF-36 is designed to examine a person’s perceived health status. The SF-36 includes one multi-item scale measuring eight health concepts: vitality, physical functioning, bodily pain, general health perceptions, physical role-, emotional role-, social role functioning, and mental health. Answers to each question are scored and summed to produce raw scale scores for each health concept which are then transformed to a 0 – 100 scale, a high score defining a more favorable health state. An aggregate summary measure is calculated by averaging the scores from the eight health concepts.
Time Frame Baseline, Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
All participants of the intent-to-treat analysis set for efficacy with evaluable data at each measurement time point.
Arm/Group Title Paliperidone Extended-release (ER)
Hide Arm/Group Description:
The recommended Paliperidone ER dose is 6 mg/day. Some patients may benefit from higher or lower doses, in the range of 3 to 12 mg/day. Paliperidone ER will be administered orally once daily.
Overall Number of Participants Analyzed 95
Mean (Standard Deviation)
Unit of Measure: scores on a scale
Baseline (n= 95) 56.39  (18.14)
Week 26 (n= 86) 67.02  (21.56)
8.Secondary Outcome
Title Sleep Evaluation Scale
Hide Description This self-administered scale rates the quality of sleep. Patients will indicate on an 11-point scale how well they have slept in the previous 7 days, from 0 (very badly) to 10 (very well).
Time Frame Baseline, Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
All participants of the intent-to-treat analysis set for efficacy with evaluable data at each measurement time point.
Arm/Group Title Paliperidone Extended-release (ER)
Hide Arm/Group Description:
The recommended Paliperidone ER dose is 6 mg/day. Some patients may benefit from higher or lower doses, in the range of 3 to 12 mg/day. Paliperidone ER will be administered orally once daily.
Overall Number of Participants Analyzed 71
Mean (Standard Deviation)
Unit of Measure: scores on a scale
Baseline (n= 71) 6.80  (2.69)
Week 26 (n= 71) 7.66  (2.52)
9.Secondary Outcome
Title Daytime Drowsiness Evaluation Scale
Hide Description This self-administered scale rates the daytime drowsiness. Patients will indicate on an 11-point scale how often they have felt drowsy within the previous 7 days, from 0 (not at all) to 10 (all the time).
Time Frame Baseline, Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
All participants of the intent-to-treat analysis set for efficacy with evaluable data at each measurement time point.
Arm/Group Title Paliperidone Extended-release (ER)
Hide Arm/Group Description:
The recommended Paliperidone ER dose is 6 mg/day. Some patients may benefit from higher or lower doses, in the range of 3 to 12 mg/day. Paliperidone ER will be administered orally once daily.
Overall Number of Participants Analyzed 71
Mean (Standard Deviation)
Unit of Measure: scores on a scale
Baseline (n= 71) 4.68  (3.21)
Week 26 (n= 71) 2.58  (2.93)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Paliperidone Extended-release (ER)
Hide Arm/Group Description The recommended Paliperidone ER dose is 6 mg/day. Some patients may benefit from higher or lower doses, in the range of 3 to 12 mg/day. Paliperidone ER will be administered orally once daily.
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   7/95 (7.37%) 
Gastrointestinal disorders   
Appendicitis  1/95 (1.05%) 
General disorders   
Clinical deterioration  1/95 (1.05%) 
Psychiatric disorders   
Psychotic episode  3/95 (3.16%) 
Major depressive disorder  1/95 (1.05%) 
Worsening of the psychiatric condition with aggressive behavior  1/95 (1.05%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Paliperidone Extended-release (ER)
Affected / at Risk (%)
Total   39/95 (41.05%) 
Nervous system disorders   
Akathisia  22/95 (23.16%) 
Parkinsonism  15/95 (15.79%) 
Psychiatric disorders   
Insomnia  24/95 (25.26%) 
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: GERENTE MEDICO REGIONAL
Organization: Jan-Cil Mexico
Phone: 52 55 5237 3410
Responsible Party: Janssen-Cilag, S.A.
ClinicalTrials.gov Identifier: NCT01724359     History of Changes
Other Study ID Numbers: CR017413
R076477SCH3029 ( Other Identifier: Janssen-Cilag Colombia )
R076477SCH3036 ( Other Identifier: Janssen-Cilag Argentina )
First Submitted: November 7, 2012
First Posted: November 9, 2012
Results First Submitted: November 27, 2012
Results First Posted: March 15, 2013
Last Update Posted: March 15, 2013