At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Double-blind, Randomized, Active-controlled, Parallel-group Study of Paliperidone Palmitate 6-Month Formulation
In Brief
A Phase 3 clinical trial evaluating PP6M, PP3M 350 mg eq., and 3 other interventions for Schizophrenia. Completed, enrolled 841 participants across 138 sites in 21 countries.
Detailed Summary
The purpose of this study is to demonstrate that injection cycles consisting of a single administration of paliperidone palmitate 6-month (PP6M) are not less effective than 2 sequentially administered injections of paliperidone palmitate 3-month PP3M) (350 or 525 mg eq.) for the prevention of relapse in participants with schizophrenia previously stabilized on corresponding doses of paliperidone palmitate 1-month (PP1M) (100 or 150 mg eq.) or PP3M (350 or 525 mg eq.).
Study Details
Timeline
Interventions
Participants will receive intramuscular injection of PP6M.
Participants will receive intramuscular injection of PP3M 350 mg eq.
Participants will receive intramuscular injection of PP3M 525 mg eq.
Participants will receive intramuscular injection of PP1M 50 to 150 mg eq.
Participants will receive matching placebo.