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A Study to Evaluate Participants Satisfaction, Quality of Life and Effectiveness of Flexible-Dose of Paliperidone Extended Release (ER) in Participants With Schizophrenia, Previously Treated With Risperidone

Primary Purpose

Schizophrenia

Status
Completed
Phase
Phase 4
Locations
Brazil
Study Type
Interventional
Intervention
Paliperidone Extended Release (ER)
Sponsored by
Janssen-Cilag Farmaceutica Ltda.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring Schizophrenia, Paliperidone

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Female participants must be postmenopausal (after the time in life when a woman stops having a menstrual period) or surgically sterile or if sexually active, practicing an effective method of birth control (e.g., oral contraceptive, intrauterine device [IUD - an intrauterine device made of plastic and/or copper that is inserted into the womb [uterus] by way of the vaginal canal to used to prevent pregnancy], diaphragm with spermicide [agent that kills spermatozoa] or condom [cover worn over the penis during sexual intercourse to prevent infection or pregnancy] with spermicide) throughout the study and have a negative serum beta - Human Chorionic Gonadotropin (HCG) pregnancy test at screening
  • Participants on oral monotherapy (treatment with a single drug) with risperidone in a regimen within the daily dosage recommended by the package insert and adhering to the prescribed risperidone regimen for at least 30 days before entering the study
  • Participants with partial response to the current risperidone regimen (persistent symptoms or unstable clinical condition) or presence of unbearable side effects
  • Potential Participants switching to another atypical antipsychotic due to their clinical response and/or side effects profile.

Exclusion Criteria:

  • Participants with past or current history of psychiatric disease other than schizophrenia according to Diagnostic and Statistical Manual of Mental Disorders (DSM)-IV
  • Participants with concomitant (given at the same time) severe (very serious, life threatening) medical or neurological disorder or risk of suicide
  • Participants previously using clozapine
  • Participants with a history of previous non-responsiveness to oral antipsychotic treatment
  • Pregnant or breast-feeding female participants

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Paliperidone Extended Release (ER)

Arm Description

Paliperidone ER tablets in the flexible dose ranging from 3 to 12 milligram (mg) will be administered orally once daily for 26 weeks of Main Phase and for additional 26 weeks of Extension Phase to participants who continued with Extension Phase. Dosage was adjusted as per the Investigator's discretion.

Outcomes

Primary Outcome Measures

Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 26 - Main Phase
The PANSS is a 30-item scale 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 and ranges from 30 to 210. Higher scores indicate worsening.
Change From Baseline in PANSS Total Score at Week 52 - Main Phase Plus Extension Phase
The PANSS is a 30-item scale 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 and ranges from 30 to 210. Higher scores indicate worsening.

Secondary Outcome Measures

Percentage of Participants With Treatment Response in PANSS Total Score - Main Phase
Participants with response in PANSS total score was defined as participants with greater than or equal to 20 percent reduction in PANSS total score from Baseline. The PANSS is a 30-item scale 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 and ranges from 30 to 210. Higher scores indicate worsening.
Percentage of Participants With Treatment Response in PANSS Total Score - Main Phase Plus Extension Phase
Participants with response in PANSS total score was defined as participants with greater than or equal to 20 percent reduction in PANSS total score from Baseline. The PANSS is a 30-item scale 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 and ranges from 30 to 210. Higher scores indicate worsening.
Change From Baseline in Positive and Negative PANSS Subscales Score at Week 4, 8, 13 and 26 - Main Phase
The PANSS positive subscale assesses 7 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). 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 Positive and Negative PANSS Subscales Score at Week 4, 8, 13, 26, 39 and 52 - Main Phase Plus Extension Phase
The PANSS Positive Subscale assesses 7 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). 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 Personal and Social Performance (PSP) Scale Score at Week 4, 8, 13 and 26 - Main Phase
The PSP scale evaluates the dysfunction degree exhibited by the participants, regarding 4 behavioral domains: useful social activities, personal and social relations, self-care and agitated and aggressive behavior. Each domain were assessed on a 6-point scale (0=absent to 5=very severe). A transformed score from 1 to 100 is generated from the raw score based on the clinical interpretation of the scores generated in the 4 areas of functioning, with a higher transformed score indicating better function.
Change From Baseline in PSP Scale Score at Week 4, 8, 13, 26, 39 and 52 - Main Phase Plus Extension Phase
The PSP scale evaluates the dysfunction degree exhibited by the participants, regarding 4 behavioral domains: useful social activities, personal and social relations, self-care and agitated and aggressive behavior. Each domain were assessed on a 6-point scale (0=absent to 5=very severe). A transformed score from 1 to 100 is generated from the raw score based on the clinical interpretation of the scores generated in the 4 areas of functioning, with a higher transformed score indicating better function.
Change From Baseline in Pittsburg Sleep Quality Index (PSQI) Score at Week 4, 8, 13 and 26 - Main Phase
The PSQI evaluates sleep behavior by means of 7 components: sleep quality, sleep latency, sleep duration, usual sleep efficiency, sleep disorders, use of sleep medication and daytime dysfunction. The sum of the 7 component scores produces a global score of subjective sleep quality that varies from 0 to 21, with higher scores indicating worse sleep quality.
Change From Baseline PSQI Score at Week 4, 8, 13, 26, 39 and 52 - Main Phase Plus Extension Phase
The PSQI evaluates sleep behavior by means of 7 components: sleep quality, sleep latency, sleep duration, usual sleep efficiency, sleep disorders, use of sleep medication and daytime dysfunction. The sum of the 7 component scores produces a global score of subjective sleep quality that varies from 0 to 21, with higher scores indicating worse sleep quality.
Number of Participants With Clinical Global Impression-Severity (CGI-S) Score - Main Phase
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.The categories included in the scale are normal, without any disease, borderline, slightly ill, moderately ill, markedly ill, severely ill and extremely ill. A rating of 1="Normal, not at all ill" and a rating of 7 ="Among the most extremely ill participants". Higher scores indicate worsening.
Number of Participants With Clinical Global Impression-Severity (CGI-S) Score - Extension Phase
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.The categories included in the scale are normal, without any disease, borderline, slightly ill, moderately ill, markedly ill, severely ill and extremely ill. A rating of 1="Normal, not at all ill" and a rating of 7 ="Among the most extremely ill participants". Higher scores indicate worsening.
Percentage of Participants With Treatment Satisfaction - Main Phase
Participant's response regarding satisfaction with the treatment were recorded. A 5-point evaluation scale was used to evaluate participant satisfaction: very good, good, moderate, bad and very bad.
Percentage of Participants With Treatment Satisfaction-Main Phase Plus Extension Phase
Participant's response regarding satisfaction with the treatment were recorded. A 5-point evaluation scale was used to evaluate participant satisfaction: very good, good, moderate, bad and very bad.
36-Item Short-Form Health Survey (SF-36) Score - Main Phase
The SF-36 is designed to assess the health status of participants. The SF-36 includes 1 multi-item scale measuring physical health component and mental health component. Physical health component includes physical functioning, role limitations due to physical health, pain and general health. Mental health component includes role limitations due to emotional problems, energy/fatigue, emotional well being and social functioning. Each item is scored 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. The score for a component (physical or mental) is an average of the individual item scores. Each component is scored on a scale of 1 to 100, where 100=highest level of functioning.
36-Item Short-Form Health Survey (SF-36) Score - Main Phase Plus Extension Phase
The SF-36 is designed to assess the health status of participants. The SF-36 includes 1 multi-item scale measuring physical health component and mental health component. Physical health component includes physical functioning, role limitations due to physical health, pain and general health. Mental health component includes role limitations due to emotional problems, energy/fatigue, emotional well being and social functioning. Each item is scored 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. The score for a component (physical or mental) is an average of the individual item scores. Each component is scored on a scale of 1 to 100, where 100=highest level of functioning.

Full Information

First Posted
November 5, 2009
Last Updated
September 17, 2013
Sponsor
Janssen-Cilag Farmaceutica Ltda.
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1. Study Identification

Unique Protocol Identification Number
NCT01010776
Brief Title
A Study to Evaluate Participants Satisfaction, Quality of Life and Effectiveness of Flexible-Dose of Paliperidone Extended Release (ER) in Participants With Schizophrenia, Previously Treated With Risperidone
Official Title
A Study to Evaluate Switching From Risperidone to Paliperidone ER (Extended Release) in the Treatment of Stable But Symptomatic Schizophrenia Outpatients: Patients Satisfaction and Quality of Life
Study Type
Interventional

2. Study Status

Record Verification Date
September 2013
Overall Recruitment Status
Completed
Study Start Date
February 2008 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
December 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Janssen-Cilag Farmaceutica Ltda.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to evaluate effectiveness, tolerability (how well a participant can stand a particular medicine or treatment), and safety of flexible-dose of paliperidone extended release (ER) in participants with schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self), previously taking risperidone (an antipsychotic), but who are not satisfied with their treatment.
Detailed Description
This is an open-label (a medical research study in which participants and researchers are told which treatments the participants are receiving, "unblinded"), multi-center (when more than 1 hospital or medical school team work on a medical research study), non-randomized, single-arm study of paliperidone ER in participants previously treated with risperidone with poor response. The study will consist of 2 phases: a main phase of 6 months and an extension phase of another 6 months. The total duration of the study will be 12 months. All participants will receive an oral (having to do with the mouth) daily dose of paliperidone ER in flexible dosage (in the range of 3-12 milligram [mg]: 3 mg, 6 mg, 9 mg, or 12 mg) according to Investigator's discretion. Efficacy and safety of participants will primarily be evaluated by Positive and Negative Syndrome Scale (PANSS) and Extrapyramidal Symptoms Rating Scale (ESRS), respectively. Participants' safety will be monitored throughout the study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
Schizophrenia, Paliperidone

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
223 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Paliperidone Extended Release (ER)
Arm Type
Experimental
Arm Description
Paliperidone ER tablets in the flexible dose ranging from 3 to 12 milligram (mg) will be administered orally once daily for 26 weeks of Main Phase and for additional 26 weeks of Extension Phase to participants who continued with Extension Phase. Dosage was adjusted as per the Investigator's discretion.
Intervention Type
Drug
Intervention Name(s)
Paliperidone Extended Release (ER)
Intervention Description
Paliperidone ER tablets in the flexible dose ranging from 3 to 12 mg will be administered orally once daily for 26 weeks of Main Phase and for additional 26 weeks of Extension Phase to participants who continued with Extension Phase. Dosage was adjusted as per the Investigator's discretion.
Primary Outcome Measure Information:
Title
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 26 - Main Phase
Description
The PANSS is a 30-item scale 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 and ranges from 30 to 210. Higher scores indicate worsening.
Time Frame
Baseline and Week 26
Title
Change From Baseline in PANSS Total Score at Week 52 - Main Phase Plus Extension Phase
Description
The PANSS is a 30-item scale 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 and ranges from 30 to 210. Higher scores indicate worsening.
Time Frame
Baseline and Week 52
Secondary Outcome Measure Information:
Title
Percentage of Participants With Treatment Response in PANSS Total Score - Main Phase
Description
Participants with response in PANSS total score was defined as participants with greater than or equal to 20 percent reduction in PANSS total score from Baseline. The PANSS is a 30-item scale 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 and ranges from 30 to 210. Higher scores indicate worsening.
Time Frame
Week 26
Title
Percentage of Participants With Treatment Response in PANSS Total Score - Main Phase Plus Extension Phase
Description
Participants with response in PANSS total score was defined as participants with greater than or equal to 20 percent reduction in PANSS total score from Baseline. The PANSS is a 30-item scale 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 and ranges from 30 to 210. Higher scores indicate worsening.
Time Frame
Week 52
Title
Change From Baseline in Positive and Negative PANSS Subscales Score at Week 4, 8, 13 and 26 - Main Phase
Description
The PANSS positive subscale assesses 7 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). 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 4, 8, 13 and 26
Title
Change From Baseline in Positive and Negative PANSS Subscales Score at Week 4, 8, 13, 26, 39 and 52 - Main Phase Plus Extension Phase
Description
The PANSS Positive Subscale assesses 7 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). 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 4, 8, 13, 26, 39 and 52
Title
Change From Baseline in Personal and Social Performance (PSP) Scale Score at Week 4, 8, 13 and 26 - Main Phase
Description
The PSP scale evaluates the dysfunction degree exhibited by the participants, regarding 4 behavioral domains: useful social activities, personal and social relations, self-care and agitated and aggressive behavior. Each domain were assessed on a 6-point scale (0=absent to 5=very severe). A transformed score from 1 to 100 is generated from the raw score based on the clinical interpretation of the scores generated in the 4 areas of functioning, with a higher transformed score indicating better function.
Time Frame
Baseline, Week 4, 8, 13 and 26
Title
Change From Baseline in PSP Scale Score at Week 4, 8, 13, 26, 39 and 52 - Main Phase Plus Extension Phase
Description
The PSP scale evaluates the dysfunction degree exhibited by the participants, regarding 4 behavioral domains: useful social activities, personal and social relations, self-care and agitated and aggressive behavior. Each domain were assessed on a 6-point scale (0=absent to 5=very severe). A transformed score from 1 to 100 is generated from the raw score based on the clinical interpretation of the scores generated in the 4 areas of functioning, with a higher transformed score indicating better function.
Time Frame
Baseline, Week 4, 8, 13, 26, 39 and 52
Title
Change From Baseline in Pittsburg Sleep Quality Index (PSQI) Score at Week 4, 8, 13 and 26 - Main Phase
Description
The PSQI evaluates sleep behavior by means of 7 components: sleep quality, sleep latency, sleep duration, usual sleep efficiency, sleep disorders, use of sleep medication and daytime dysfunction. The sum of the 7 component scores produces a global score of subjective sleep quality that varies from 0 to 21, with higher scores indicating worse sleep quality.
Time Frame
Baseline, Week 4, 8, 13 and 26
Title
Change From Baseline PSQI Score at Week 4, 8, 13, 26, 39 and 52 - Main Phase Plus Extension Phase
Description
The PSQI evaluates sleep behavior by means of 7 components: sleep quality, sleep latency, sleep duration, usual sleep efficiency, sleep disorders, use of sleep medication and daytime dysfunction. The sum of the 7 component scores produces a global score of subjective sleep quality that varies from 0 to 21, with higher scores indicating worse sleep quality.
Time Frame
Baseline, Week 4, 8, 13, 26, 39 and 52
Title
Number of Participants With Clinical Global Impression-Severity (CGI-S) Score - Main Phase
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.The categories included in the scale are normal, without any disease, borderline, slightly ill, moderately ill, markedly ill, severely ill and extremely ill. A rating of 1="Normal, not at all ill" and a rating of 7 ="Among the most extremely ill participants". Higher scores indicate worsening.
Time Frame
Baseline, Week 4, 8, 13 and 26
Title
Number of Participants With Clinical Global Impression-Severity (CGI-S) Score - Extension Phase
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.The categories included in the scale are normal, without any disease, borderline, slightly ill, moderately ill, markedly ill, severely ill and extremely ill. A rating of 1="Normal, not at all ill" and a rating of 7 ="Among the most extremely ill participants". Higher scores indicate worsening.
Time Frame
Week 39 and 52
Title
Percentage of Participants With Treatment Satisfaction - Main Phase
Description
Participant's response regarding satisfaction with the treatment were recorded. A 5-point evaluation scale was used to evaluate participant satisfaction: very good, good, moderate, bad and very bad.
Time Frame
Baseline, Week 4, 8, 13 and 26
Title
Percentage of Participants With Treatment Satisfaction-Main Phase Plus Extension Phase
Description
Participant's response regarding satisfaction with the treatment were recorded. A 5-point evaluation scale was used to evaluate participant satisfaction: very good, good, moderate, bad and very bad.
Time Frame
Baseline, Week 4, 8, 13, 26, 39 and 52
Title
36-Item Short-Form Health Survey (SF-36) Score - Main Phase
Description
The SF-36 is designed to assess the health status of participants. The SF-36 includes 1 multi-item scale measuring physical health component and mental health component. Physical health component includes physical functioning, role limitations due to physical health, pain and general health. Mental health component includes role limitations due to emotional problems, energy/fatigue, emotional well being and social functioning. Each item is scored 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. The score for a component (physical or mental) is an average of the individual item scores. Each component is scored on a scale of 1 to 100, where 100=highest level of functioning.
Time Frame
Baseline and Week 26
Title
36-Item Short-Form Health Survey (SF-36) Score - Main Phase Plus Extension Phase
Description
The SF-36 is designed to assess the health status of participants. The SF-36 includes 1 multi-item scale measuring physical health component and mental health component. Physical health component includes physical functioning, role limitations due to physical health, pain and general health. Mental health component includes role limitations due to emotional problems, energy/fatigue, emotional well being and social functioning. Each item is scored 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. The score for a component (physical or mental) is an average of the individual item scores. Each component is scored on a scale of 1 to 100, where 100=highest level of functioning.
Time Frame
Baseline and Week 52
Other Pre-specified Outcome Measures:
Title
Change From Baseline in Extrapyradimal Symptoms Rating Scale (ESRS) Total Score at Week 4, 8, 13 and 26 - Main Phase
Description
An ESRS scale is used to assess the extrapyramidal symptoms attributable to antipsychotics. It consists of 8 items to assess individual symptoms and each item is assessed from 0 (none, normal) to 4 (severe). The total score is the sum of the 8 item scores, for a total range of 0 (normal) to 32 (severe). The items for the assessment of individual symptoms are classified into 4 categories of parkinsonism, akathisia, dystonia and dyskinesia.
Time Frame
Baseline, Week 4, 8, 13 and 26
Title
Change From Baseline in ESRS Total Score at Week 4, 8, 13, 26, 39 and 52 - Main Phase Plus Extension Phase
Description
An ESRS scale is used to assess the extrapyramidal symptoms attributable to antipsychotics. It consists of 8 items to assess individual symptoms and each item is assessed from 0 (none, normal) to 4 (severe). The total score is the sum of the 8 item scores, for a total range of 0 (normal) to 32 (severe). The items for the assessment of individual symptoms are classified into 4 categories of parkinsonism, akathisia, dystonia and dyskinesia.
Time Frame
Baseline, Week 4, 8, 13, 26, 39 and 52

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Female participants must be postmenopausal (after the time in life when a woman stops having a menstrual period) or surgically sterile or if sexually active, practicing an effective method of birth control (e.g., oral contraceptive, intrauterine device [IUD - an intrauterine device made of plastic and/or copper that is inserted into the womb [uterus] by way of the vaginal canal to used to prevent pregnancy], diaphragm with spermicide [agent that kills spermatozoa] or condom [cover worn over the penis during sexual intercourse to prevent infection or pregnancy] with spermicide) throughout the study and have a negative serum beta - Human Chorionic Gonadotropin (HCG) pregnancy test at screening Participants on oral monotherapy (treatment with a single drug) with risperidone in a regimen within the daily dosage recommended by the package insert and adhering to the prescribed risperidone regimen for at least 30 days before entering the study Participants with partial response to the current risperidone regimen (persistent symptoms or unstable clinical condition) or presence of unbearable side effects Potential Participants switching to another atypical antipsychotic due to their clinical response and/or side effects profile. Exclusion Criteria: Participants with past or current history of psychiatric disease other than schizophrenia according to Diagnostic and Statistical Manual of Mental Disorders (DSM)-IV Participants with concomitant (given at the same time) severe (very serious, life threatening) medical or neurological disorder or risk of suicide Participants previously using clozapine Participants with a history of previous non-responsiveness to oral antipsychotic treatment Pregnant or breast-feeding female participants
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janssen-Cilag Farmaceutica Ltda. Clinical Trial
Organizational Affiliation
Janssen-Cilag Farmaceutica Ltda.
Official's Role
Study Director
Facility Information:
City
Belo Horizonte
Country
Brazil
City
Criciúma
Country
Brazil
City
Curitiba
Country
Brazil
City
Goiânia
Country
Brazil
City
Itapira
Country
Brazil
City
Marília
Country
Brazil
City
Rio De Janeiro
Country
Brazil
City
Salvador
Country
Brazil
City
Sao Paulo
Country
Brazil
City
Sorocaba
Country
Brazil
City
São Paulo
Country
Brazil

12. IPD Sharing Statement

Citations:
PubMed Identifier
24289141
Citation
Gattaz WF, Campos JA, Lacerda AL, Henna E, Ruschel SI, Bressan RA, de Oliveira IR, Rocha FL, Grabowski HM, Sacomani E Jr, Louza MR, Quevedo J, Elkis H, Zorzetto Filho D, Perico Cde A, Lawson FL, Appolinario JC. Switching from oral risperidone to flexibly dosed oral paliperidone extended-release: core symptoms, satisfaction, and quality of life in patients with stable but symptomatic schizophrenia: the RISPALI study. Curr Med Res Opin. 2014 Apr;30(4):695-709. doi: 10.1185/03007995.2013.869201. Epub 2013 Dec 16.
Results Reference
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A Study to Evaluate Participants Satisfaction, Quality of Life and Effectiveness of Flexible-Dose of Paliperidone Extended Release (ER) in Participants With Schizophrenia, Previously Treated With Risperidone

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