At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 667 enrolled
Drug / intervention
Placebo +1 moredrug
Likely dose
paliperidone palmitate 234 mgfrom 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, Parellel-Group Study of Paliperidone Palmitate Evaluating Time to Relapse in Subjects With Schizoaffective Disorder
In Brief
A Phase 3 clinical trial evaluating Placebo and paliperidone palmitate for Schizoaffective Disorder. Completed, enrolled 667 participants across 80 sites in 8 countries.
Detailed Summary
This study will evaluate the efficacy of paliperidone palmitate compared with placebo in the delay of relapse of the symptoms of schizoaffective disorder. This study will also assess the safety and tolerability of paliperidone palmitate in patients with schizoaffective disorder.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSchizoaffective Disorder
CountriesBulgaria, India, Malaysia, Philippines, Romania, South Africa, Ukraine, United States
Collaborators--
Timeline
Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedSep 2010
Enrollment StartSep 2010
Primary CompletionOct 2013
TodayJul 2026
First PostedSep 1, 2010
Enrollment StartSep 1, 2010
Primary CompletionOct 1, 2013
TodayJul 2, 2026
Enrollment to primary: 3.1 yearsPosted 15.8 years ago
Interventions
Placebodrug
monthly by i.m. injection for 15 months
paliperidone palmitatedrug
78, 117, 156, 234 mg (50, 75, 100, or 150 mg eq.) monthly by i.m. injection for 15 months