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

NCT ID: NCT01010776

Last Updated: 2013-11-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 223 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-02-29
• Study Completion Date: 2009-12-31

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.

Conditions

Schizophrenia

Keywords

Schizophrenia; Paliperidone

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Paliperidone Extended Release (ER)

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.

Group Type: EXPERIMENTAL

Paliperidone Extended Release (ER)

Intervention Type: DRUG

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.

Interventions

Paliperidone Extended Release (ER)

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.

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Janssen-Cilag Farmaceutica Ltda.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janssen-Cilag Farmaceutica Ltda. Clinical Trial

Role: STUDY_DIRECTOR

Janssen-Cilag Farmaceutica Ltda.

Locations

Belo Horizonte, , Brazil

Criciúma, , Brazil

Curitiba, , Brazil

Goiânia, , Brazil

Itapira, , Brazil

Marília, , Brazil

Rio de Janeiro, , Brazil

Salvador, , Brazil

São Paulo, , Brazil

Sorocaba, , Brazil

Countries

Brazil

References

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.

Reference Type: DERIVED

PMID: 24289141 (View on PubMed)

Other Identifiers

R076477SCH4011

Identifier Type: OTHER

Identifier Source: secondary_id

CR013744

Identifier Type: -

Identifier Source: org_study_id