Back to resultsTolerability, Safety and Efficacy of Flexibly Dosed Paliperidone ER in Patients With Schizophrenia (PERFLEX)
Primary Purpose
Schizophrenia
Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Paliperidone ER
Sponsored by
About this trial
This is an interventional treatment trial for Schizophrenia focused on measuring Schizophrenia, Paliperidone extended-release (ER), Antipsychotic agents
Eligibility Criteria
Inclusion Criteria:
- Patient meets the criteria for schizophrenia
- Patient is previously non-acute and has been given an adequate dose of an appropriate oral antipsychotic for an adequate period of time prior to enrollment, but previous treatment is considered unsuccessful due to one or more of the following reasons: lack of efficacy, lack of tolerability or safety, lack of compliance and/or other reasons to switch to another antipsychotic medication
- Patient is healthy on the basis of a physical examination and vital signs at screening
- Women must be postmenopausal for at least 1 year, surgically sterile, abstinent, or, if sexually active, agree to practice an effective method of birth control before entry and throughout the study
Exclusion Criteria:
- Patients on clozapine, any conventional depot neuroleptic or risperidone long-acting injections during the last 3 months
- Patients with serious unstable medical condition, including known clinically relevant laboratory abnormalities
- Patients with history or current symptoms of tardive dyskinesia and neuroleptic malignant syndrome
- Patients judged to be at high risk for adverse events, violence, or self-harm
- Patients with known hypersensitivity to paliperidone ER or to risperidone
- Patients with a current use or known history (over the past 6 months) of substance dependence
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Paliperidone ER
Arm Description
Outcomes
Primary Outcome Measures
Change From Baseline in Total Positive and Negative Syndrome Scale (PANSS) Score
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.
Secondary Outcome Measures
Change From Baseline in Total Positive and Negative Syndrome Scale (PANSS) - Positive Subscale Score
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).
Change From Baseline in Total Positive and Negative Syndrome Scale (PANSS) - Negative Subscale Score
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).
Change From Baseline in Total Positive and Negative Syndrome Scale (PANSS) - General Psychopathology Subscale Score
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).
Clinical Global Impression-Severity (CGIS)
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.
Personal and Social Performance (PSP) Scale
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.
Health Status as Measured by Self-rated Health Status Survey SF-36
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.
Sleep Evaluation Scale
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).
Daytime Drowsiness Evaluation Scale
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).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01724359
Brief Title
Tolerability, Safety and Efficacy of Flexibly Dosed Paliperidone ER in Patients With Schizophrenia
Acronym
PERFLEX
Official Title
An Open-label Prospective Trial to Explore the Tolerability, Safety and Efficacy of Flexibly Dosed Paliperidone ER in Subjects With Schizophrenia
Study Type
Interventional
2. Study Status
Record Verification Date
February 2013
Overall Recruitment Status
Completed
Study Start Date
February 2008 (undefined)
Primary Completion Date
November 2009 (Actual)
Study Completion Date
November 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Janssen-Cilag, S.A.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to evaluate efficacy, safety and tolerability of flexible, once-daily doses of paliperidone extended-release (ER) in patients with schizophrenia from Argentina and Colombia that previously failed treatment with other antipsychotic agents.
Detailed Description
This is a single arm (one group of patients), open-label (all people know the identity of the intervention) multicenter 6-month study. Throughout the study flexible dosing of paliperidone ER in a range of 3 to 12 mg/day may be used. Flexible dosing will allow investigators to adjust the dosage of each patient based on the individual needs. Patients will receive 3, 6, 9 or 12 mg of paliperidone ER once daily for 6 months. The tablets will be taken orally. Adjustment of the dosage will be done at the investigator's discretion, based on the individual patient's clinical response and tolerability to the study drug.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
Schizophrenia, Paliperidone extended-release (ER), Antipsychotic agents
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
95 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Paliperidone ER
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Paliperidone ER
Intervention Description
The recommended Paliperidone extended-release (ER) dose will be 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. Adjustment of the dosage will be done at the investigator's discretion.
Primary Outcome Measure Information:
Title
Change From Baseline in Total Positive and Negative Syndrome Scale (PANSS) Score
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
Secondary Outcome Measure Information:
Title
Change From Baseline in Total Positive and Negative Syndrome Scale (PANSS) - Positive Subscale Score
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
Title
Change From Baseline in Total Positive and Negative Syndrome Scale (PANSS) - Negative Subscale Score
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
Title
Change From Baseline in Total Positive and Negative Syndrome Scale (PANSS) - General Psychopathology Subscale Score
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
Title
Clinical Global Impression-Severity (CGIS)
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
Title
Personal and Social Performance (PSP) Scale
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
Title
Health Status as Measured by Self-rated Health Status Survey SF-36
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
Title
Sleep Evaluation Scale
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
Title
Daytime Drowsiness Evaluation Scale
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patient meets the criteria for schizophrenia
Patient is previously non-acute and has been given an adequate dose of an appropriate oral antipsychotic for an adequate period of time prior to enrollment, but previous treatment is considered unsuccessful due to one or more of the following reasons: lack of efficacy, lack of tolerability or safety, lack of compliance and/or other reasons to switch to another antipsychotic medication
Patient is healthy on the basis of a physical examination and vital signs at screening
Women must be postmenopausal for at least 1 year, surgically sterile, abstinent, or, if sexually active, agree to practice an effective method of birth control before entry and throughout the study
Exclusion Criteria:
Patients on clozapine, any conventional depot neuroleptic or risperidone long-acting injections during the last 3 months
Patients with serious unstable medical condition, including known clinically relevant laboratory abnormalities
Patients with history or current symptoms of tardive dyskinesia and neuroleptic malignant syndrome
Patients judged to be at high risk for adverse events, violence, or self-harm
Patients with known hypersensitivity to paliperidone ER or to risperidone
Patients with a current use or known history (over the past 6 months) of substance dependence
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janssen-Cilag S.A. Clinical Trial
Organizational Affiliation
Janssen-Cilag, S.A.
Official's Role
Study Director
Facility Information:
City
Buenos Aires N/A
Country
Argentina
City
Buenos Aires
Country
Argentina
City
Rosario
Country
Argentina
City
Bogota
Country
Colombia
City
Cali
Country
Colombia
City
Medellin
Country
Colombia
12. IPD Sharing Statement
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Tolerability, Safety and Efficacy of Flexibly Dosed Paliperidone ER in Patients With Schizophrenia
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