Clinical trial NCT01010776: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Schizophrenia
Keywords: Schizophrenia
Paliperidone
Lead sponsor: Janssen-Cilag Farmaceutica Ltda.
Sponsor class: INDUSTRY
First posted: 2009-11-10
Enrollment: 223
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 26 - Main Phase
timeFrame: Baseline and Week 26
measure: Change From Baseline in PANSS Total Score at Week 52 - Main Phase Plus Extension Phase
timeFrame: Baseline and Week 52
Secondary outcomes:
measure: Percentage of Participants With Treatment Response in PANSS Total Score - Main Phase
timeFrame: Week 26
measure: Percentage of Participants With Treatment Response in PANSS Total Score - Main Phase Plus Extension Phase
timeFrame: Week 52
measure: Change From Baseline in Positive and Negative PANSS Subscales Score at Week 4, 8, 13 and 26 - Main Phase
timeFrame: Baseline, Week 4, 8, 13 and 26
measure: Change From Baseline in Positive and Negative PANSS Subscales Score at Week 4, 8, 13, 26, 39 and 52 - Main Phase Plus Extension Phase
timeFrame: Baseline, Week 4, 8, 13, 26, 39 and 52
measure: Change From Baseline in Personal and Social Performance (PSP) Scale Score at Week 4, 8, 13 and 26 - Main Phase
timeFrame: Baseline, Week 4, 8, 13 and 26
measure: Change From Baseline in PSP Scale Score at Week 4, 8, 13, 26, 39 and 52 - Main Phase Plus Extension Phase
timeFrame: Baseline, Week 4, 8, 13, 26, 39 and 52
measure: Change From Baseline in Pittsburg Sleep Quality Index (PSQI) Score at Week 4, 8, 13 and 26 - Main Phase
timeFrame: Baseline, Week 4, 8, 13 and 26
measure: Change From Baseline PSQI Score at Week 4, 8, 13, 26, 39 and 52 - Main Phase Plus Extension Phase
timeFrame: Baseline, Week 4, 8, 13, 26, 39 and 52
measure: Number of Participants With Clinical Global Impression-Severity (CGI-S) Score - Main Phase
timeFrame: Baseline, Week 4, 8, 13 and 26
measure: Number of Participants With Clinical Global Impression-Severity (CGI-S) Score - Extension Phase
timeFrame: Week 39 and 52
measure: Percentage of Participants With Treatment Satisfaction - Main Phase
timeFrame: Baseline, Week 4, 8, 13 and 26
measure: Percentage of Participants With Treatment Satisfaction-Main Phase Plus Extension Phase
timeFrame: Baseline, Week 4, 8, 13, 26, 39 and 52
measure: 36-Item Short-Form Health Survey (SF-36) Score - Main Phase
timeFrame: Baseline and Week 26
measure: 36-Item Short-Form Health Survey (SF-36) Score - Main Phase Plus Extension Phase
timeFrame: Baseline and Week 52
Other outcomes:
measure: Change From Baseline in Extrapyradimal Symptoms Rating Scale (ESRS) Total Score at Week 4, 8, 13 and 26 - Main Phase
timeFrame: Baseline, Week 4, 8, 13 and 26
measure: Change From Baseline in ESRS Total Score at Week 4, 8, 13, 26, 39 and 52 - Main Phase Plus Extension Phase
timeFrame: Baseline, Week 4, 8, 13, 26, 39 and 52
Locations:
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
Study officials:
affiliation: Janssen-Cilag Farmaceutica Ltda.
name: Janssen-Cilag Farmaceutica Ltda. Clinical Trial
role: STUDY_DIRECTOR
References:
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.