At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
An Open-label Prospective Trial to Evaluate the Tolerability, Safety and Maintained Efficacy of a Transition to Paliperidone ER in Subjects With Schizophrenia Previously Unsuccessfully Treated With Other Oral Antipsychotics
In Brief
A Phase 4 clinical trial evaluating Paliperidone ER for Schizophrenia. Completed, enrolled 299 participants.
Detailed Summary
The purpose of the study is to explore the maintained efficacy, tolerability, and safety of flexibly dosed 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 unsuccessfully treated with other oral atypical antipsychotic medication.
Study Details
Timeline
Interventions
Participants will receive paliperidone ER tablet in dose range of 3 to12 milligram (mg) per day orally once daily for 24 weeks as per Investigator's discretion based on the individual participant's clinical response to and tolerability of the study drug.