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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
223
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.
Unnamed facility
Belo Horizonte, Brazil
Unnamed facility
Criciúma, Brazil
Unnamed facility
Curitiba, Brazil
Unnamed facility
Goiânia, Brazil
Unnamed facility
Itapira, Brazil
Unnamed facility
Marília, Brazil
Unnamed facility
Rio de Janeiro, Brazil
Unnamed facility
Salvador, Brazil
Unnamed facility
São Paulo, Brazil
Unnamed facility
Sorocaba, Brazil
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.
Time frame: Baseline and Week 26
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.
Time frame: Baseline and Week 52
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.
Time frame: Week 26
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.
Time frame: Week 52
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).
Time frame: Baseline, Week 4, 8, 13 and 26
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).
Time frame: Baseline, Week 4, 8, 13, 26, 39 and 52
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.
Time frame: Baseline, Week 4, 8, 13 and 26
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.
Time frame: Baseline, Week 4, 8, 13, 26, 39 and 52
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.
Time frame: Baseline, Week 4, 8, 13 and 26
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.
Time frame: Baseline, Week 4, 8, 13, 26, 39 and 52
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.
Time frame: Baseline, Week 4, 8, 13 and 26
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.
Time frame: Week 39 and 52
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.
Time frame: Baseline, Week 4, 8, 13 and 26
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.
Time frame: Baseline, Week 4, 8, 13, 26, 39 and 52
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.
Time frame: Baseline and Week 26
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.
Time frame: Baseline and Week 52
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