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
Sponsor study identifier
Secondary identifiers
OTHER · Janssen-Cilag Farmaceutica Ltda.
interventional
223
1 country
10
Study Start
February 2008
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2009
Actual (reported)Study Completion
December 2009
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2009
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 2008
Date type not reportedThis date has not been verified as actual or estimated.
November 5, 2009
Actual (reported)November 10, 2009
Actual (reported)December 2009
Actual (reported)December 2009
Actual (reported)November 20, 2013
Actual (reported)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.
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.
Baseline and Week 52
Percentage of Participants With Treatment Response in PANSS Total Score - Main Phase
Week 26
Percentage of Participants With Treatment Response in PANSS Total Score - Main Phase Plus Extension Phase
Week 52
Change From Baseline in Positive and Negative PANSS Subscales Score at Week 4, 8, 13 and 26 - Main Phase
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
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
Baseline, Week 4, 8, 13 and 26
Change From Baseline in Extrapyradimal Symptoms Rating Scale (ESRS) Total Score at Week 4, 8, 13 and 26 - Main Phase
Baseline, Week 4, 8, 13 and 26
Change From Baseline in ESRS Total Score at Week 4, 8, 13, 26, 39 and 52 - Main Phase Plus Extension Phase
Baseline, Week 4, 8, 13, 26, 39 and 52
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.
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.
Belo Horizonte, Brazil
Criciúma, Brazil
Curitiba, Brazil
Goiânia, Brazil
Itapira, Brazil
Marília, Brazil
Rio de Janeiro, Brazil
Salvador, Brazil
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.
Janssen-Cilag Farmaceutica Ltda. Clinical Trial
Janssen-Cilag Farmaceutica Ltda.
223 participants (actual enrollment reported by the registry).
First Submitted
November 5, 2009
First Posted
November 10, 2009
Study Start
February 2008
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
São Paulo, Brazil
Sorocaba, Brazil
Primary Completion
December 2009
Actual (reported)Study Completion
December 2009
Actual (reported)Last Updated
November 20, 2013
Results First Posted
November 20, 2013
Record last verified: 2013-09
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: