Conditions: Schizophrenia
Keywords: Schizophrenia Paliperidone
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 223
Healthy volunteers: no

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.

Arms:
arm 1: 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.

Interventions: intervention 1: Paliperidone Extended Release (ER)
Intervention descriptions: intervention 1: 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.

Protocol document: