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

A 52-Week, Open-Label, Prospective, Multicenter, International Study of a Transition to the Paliperidone Palmitate 3-Month Formulation In Patients With Schizophrenia Previously Stabilized on the Paliperidone Palmitate 1-Month Formulation

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 306 (actual)
• Sponsor: Janssen-Cilag Ltd. · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is an international, multicenter (study conducted at multiple sites) study designed to estimate remission rates and assess treatment response, tolerability, and patterns of use of Paliperidone Palmitate 3-Month Formulation (PP3M) in a diverse population of participants with schizophrenia. The study will consist of a screening phase (Day -7 to Day 1), a 52-week, open-label, flexible-dose PP3M treatment phase and a follow up safety assessment 3 months ( +/-14 days ) after the month 12 visit or early discontinuation. Participants' Safety will be monitored throughout the study.

Conditions

• Schizophrenia

Interventions

Type	Name	Description
DRUG	Paliperidone palmitate 3 month formulation (PP3M)	Participants will receive intramuscular injection of Paliperidone Palmitate 3-Month Formulation (PP3M) on Day 1 at a starting dose of 175 milligram equivalent (mg eq) up to 525 mg eq based on last Paliperidone Palmitate 1-Month Formulation (PP1M) dose (at a dose of 3.5-fold multiple of the participant's last PP1M dose). Subsequent PP3M injections will be given at Month 3, Month 6, and Month 9 and dose can be adjusted flexibly in increments within the range of 175 to 525 mg eq.

Timeline

• Start date: 2016-04-28
• Primary completion: 2018-03-26
• Completion: 2018-03-26
• First posted: 2016-03-18
• Last updated: 2025-04-27

Locations

46 sites across 15 countries: Croatia, Denmark, France, Germany, Greece, Israel, Malaysia, Netherlands, Russia, Saudi Arabia, South Korea, Spain, Taiwan, Turkey (Türkiye), United Kingdom