At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 307 enrolled
Drug / intervention
Placebo +2 moredrug
Likely dose
Paliperidone ER 12mgfrom 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.
A Randomized, Double-blind, Placebo-controlled, Parallel- Group Study to Evaluate the Efficacy and Safety of Flexible-dose Paliperidone ER in the Treatment of Patients With Schizoaffective Disorder.
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.·interventional·Posted Dec 18, 2006·Updated May 9, 2014
In Brief
A Phase 3 clinical trial evaluating Placebo and Paliperidone ER for Schizoaffective Disorder and Psychotic Disorder. Completed, enrolled 307 participants across 44 sites in 6 countries.
Detailed Summary
The purpose of this study is to measure the effectiveness and assess the safety of different dosages (from 3 mg/day to 12 mg/day) of the antipsychotic paliperidone extended-release (ER) in patients who are experiencing an acute episode of schizoaffective disorder.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSchizoaffective Disorder, Psychotic Disorder
CountriesIndia, Malaysia, Philippines, Romania, South Korea, United States
CollaboratorsJanssen, LP
Timeline
Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartDec 2006
First PostedDec 2006
Primary CompletionJun 2008
TodayJul 2026
First PostedDec 18, 2006
Enrollment StartDec 1, 2006
Primary CompletionJun 1, 2008
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 19.5 years ago
Interventions
Placebodrug
for 6 weeks
Paliperidone ERdrug
(3-12mg/day in 3 mg/day increments for 6 weeks)
Paliperidone ERdrug
(3-12mg/day in 3 mg/day increments for 6 weeks)