drugset / Trial / NCT02713282

A Study of Transition to the Paliperidone Palmitate 3-Month Formulation In Participants With Schizophrenia Previously Stabilized on the Paliperidone Palmitate 1-Month Formulation

NCT02713282

Phase 3 Completed 306 enrolled Janssen-Cilag Ltd.
NaSingle-groupOpen-labelTreatment

Summary

The purpose of this study is to estimate the proportion of participants fulfilling criteria for symptomatic remission following a transition to 12 months treatment with flexible-dose paliperidone palmitate 3 month formulation (PP3M) in participants with schizophrenia previously adequately treated with paliperidone palmitate 1 month formulation (PP1M) for at least 4 months.

Timeline

Start
2016-04-28
Primary completion
2018-03-26
Completion
2018-03-26

Drugs

EvaluationDrugModalityDoseRoute
Subject paliperidone palmitate Unknown 175 mg Intramuscular
Subject paliperidone palmitate Unknown 525 mg Intramuscular

Indications