At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 316 enrolled
Drug / intervention
Paliperidone ER +2 moredrug
Likely dose
Paliperidone ER 6mgfrom 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 Two Dosages of Paliperidone ER in the Treatment of Patients With Schizoaffective Disorder.
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.·interventional·Posted Nov 8, 2006·Updated Jul 29, 2013
In Brief
A Phase 3 clinical trial evaluating Paliperidone ER and Placebo for Schizoaffective Disorder and Psychotic Disorder. Completed, enrolled 316 participants.
Detailed Summary
The purpose of this study is to measure the effectiveness and assess the safety of two dosages 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
Countries--
CollaboratorsJanssen, LP
Timeline
Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartNov 2006
First PostedNov 2006
Primary CompletionFeb 2008
TodayJul 2026
First PostedNov 8, 2006
Enrollment StartNov 1, 2006
Primary CompletionFeb 1, 2008
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 19.7 years ago
Interventions
Paliperidone ERdrug
6mg/day paliperidone er for 6 weeks
Paliperidone ERdrug
12mg/day paliperidone er for 6 weeks
Placebodrug
Placebo for 6 weeks