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Paliperidone palmitate 3-month treatment results in symptomatic remission in patients with schizophrenia

a randomized, multicenter, double-blind, and noninferiority study

Savitz, Adam J.a; Xu, Haiyana; Gopal, Sriharia; Nuamah, Isaaca; Hough, Davida; Mathews, Majub

International Clinical Psychopharmacology: November 2017 - Volume 32 - Issue 6 - p 329–336
doi: 10.1097/YIC.0000000000000190

The current analysis assessed symptomatic and functional remission achieved following paliperidone palmitate 3-month (PP3M) versus 1-month (PP1M) treatment in patients (age: 18–70 years) with schizophrenia, previously stabilized on PP1M. Following a less than or equal to 3-week screening, and a 17-week, flexible-dosed, open-label phase [PP1M: day 1 (150 mg eq. deltoid), day 8 (100 mg eq. deltoid), weeks 5, 9, and 13 (50, 75, 100, or 150 mg eq., deltoid/gluteal)], clinically-stable patients were randomized (1 : 1) to PP3M (fixed-dose, 175, 263, 350, or 525 mg eq. deltoid/gluteal) or PP1M (fixed-dose, 50, 75, 100, or 150 mg eq. deltoid/gluteal) in 48-week double-blind (DB) phase. Symptomatic remission was assessed using Andreasen’s criteria. Functional remission was assessed using Personal and Social Performance scale (PSP). More than 50% patients in both groups achieved symptomatic remission (PP3M: 50.3%; PP1M: 50.8%) during last 6 months of DB phase. Similar percentage of patients of both groups achieved functional remission (defined as PSP score>70, PP3M: 42.5%; PP1M: 43.9%) and combined remission (symptomatic and functional remission, PP3M: 25.1%; PP1M: 26.6%) during last 6 months of DB phase. Most patients who achieved remission at DB baseline maintained their remission status throughout the DB phase. PP3M and PP1M achieved comparable symptomatic and functional remissions during the DB phase.

aJanssen Research and Development

bJanssen Scientific Affairs, LLC, Titusville, New Jersey, USA

This study was presented as poster presentation at 5th Biennial Schizophrenia International Research Society (SIRS) Conference, Florence, Italy, 2–6 April 2016; American Psychiatry Association (APA), Annual Meeting 2016, Atlanta, GA, USA, 14–18 May 2016; 71st Annual Meeting, Society of Biological Psychiatry (SOBP) 2016, Atlanta, GA, USA, 12–14 May 2016; and Annual Meeting, American Society of Clinical Psychopharmacology (ASCP), 2016, Scottsdale, AZ, USA, 31 May to 3 June 2016.

Correspondence to Adam J. Savitz, MD, Janssen Research and Development, LLC, Titusville, NJ, USA Tel: +1 917 623 0816; fax: +1 609 269 2167; e-mail:

Received March 17, 2017

Accepted July 5, 2017

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