R092670SCH3015 Paliperidone Palmitate 3 Monthly - REMISSIO

• Research type

  Research Study

• Full title

  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

• IRAS ID

  198888

• Contact name

  Stephen Lawrie

• Contact email

  S.Lawrie@ed.ac.uk

• Sponsor organisation

  Janssen-Cilag International NV

• Eudract number

  2015-004835-10

• Duration of Study in the UK

  1 years, 10 months, 28 days

• Research summary

  This is an open-label study to estimate remission rates and assess treatment response, tolerability, and patterns of use of Paliperidone Palmitate 3-Monthly Formulation (PP3M) in a diverse population of patients with schizophrenia, as seen in routine day-to-day practice, who are transitioned from Paliperidone Palmitate 1-Monthly Formulation (PP1M) to PP3M. PP3M dosing will be flexible based on individual patient needs (eg. because of lack of efficacy or side effects, or due to fluctuations in the course of the disease) therefore, generating data in a population of patients more representative of routine practice, and allowing treating physicians to modify doses of PP3M and concomitant medication as needed, will help to provide clinically meaningful information for the optimal use of this new treatment option for patients with schizophrenia.

• REC name

  Scotland A REC

• REC reference

  16/SS/0038

• Date of REC Opinion

  23 Mar 2016

• REC opinion

  Further Information Favourable Opinion