At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 353 enrolled
Drug / intervention
Paliperidone ERdrug
Likely dose
Paliperidone ER 6 milligramfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
An Open Label, Prospective, Non-Comparative Study to Evaluate Flexible Dose of Paliperidone ER and Clinical Response in the Treatment of Subjects With Schizophrenia
In Brief
A Phase 4 clinical trial evaluating Paliperidone ER for Schizophrenia. Completed, enrolled 353 participants.
Detailed Summary
The purpose of this study is to evaluate the effectiveness of paliperidone ER for the treatment of schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self) participants.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSchizophrenia
Countries--
Collaborators--
Timeline
Phase 4CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartMay 2008
Primary CompletionApr 2009
First PostedApr 2012
TodayJul 2026
First PostedApr 13, 2012
Enrollment StartMay 1, 2008
Primary CompletionApr 1, 2009
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 14.2 years ago
Interventions
Paliperidone ERdrug
Participants will receive paliperidone ER 6 milligram (mg) orally once daily up to Week 12. Dose adjustment will be done at Week 2, 4 and 8 as per investigator's discretion based upon participant's CGI-I score.