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

PHASE3CompletedINTERVENTIONAL
Enrollment

306

Participants

Timeline

Start Date

April 28, 2016

Primary Completion Date

March 26, 2018

Study Completion Date

March 26, 2018

Conditions
Schizophrenia
Interventions
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.

Trial Locations (46)

Unknown

Rijeka

Zagreb

Esbjerg

Clermont-Ferrand

Montpellier

Paris

Rennes

Toulon

Berlin

Hamburg

Oranienburg

Stralsund

Athens

Heraklion

Nea Kifissia

Thessaloniki

Beer Yaakov

Ramat Gan

Ipoh

Johor Bahru

Kuala Lumpur

Assen

Groningen

Moscow

Saint Petersburg

Jeddah

Gwangju

Gyeonggi-do

Jeonju

Seoul

Bilbao

Madrid

Oviedo

Sabadell

Torrevieja

Valencia

New Taipei City

Tainan City

Taoyuan District

Ankara

Bursa

Istanbul

Sakarya

Derby

Edinburgh

Reading

All Listed Sponsors
lead

Janssen-Cilag Ltd.

INDUSTRY

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 | Biotech Hunter | Biotech Hunter