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P03-126 - Patient Functioning with Flexible Doses of Paliperidone ER - a 6-month Prospective Study

Published online by Cambridge University Press:  17 April 2020

A. Schreiner ,
D. Hoeben ,
M. Lahaye ,
C. Tessier ,
M. Ivanov ,
B. Millet ,
B. Rembeck ,
J. Turczynski  and
E. Smeraldi
A. Schreiner
Affiliation:
EMEA Medical Affairs, Janssen-Cilag, Neuss, Germany
D. Hoeben
Affiliation:
EMEA Medical Affairs, Janssen Pharmaceutica N.V., Beerse, Belgium
M. Lahaye
Affiliation:
Janssen Cilag Netherlands B.V., Tilburg, The Netherlands
C. Tessier
Affiliation:
EMEA Medical Affairs, Janssen Cilag France, Paris, France
M. Ivanov
Affiliation:
Dept. of Biological Therapy of Mentally Diseased Patients, St. Petersburg Scientific Research Psychoneurological Institute n.a.V. M. Bekhterev of Roszdrav, St. Petersburg, Russia
B. Millet
Affiliation:
CH Guillaume Régnier, Service Hospitalo - Universitaire de Psychiatrie Adulte, Rennes, France
B. Rembeck
Affiliation:
Department of Psychiatry, PVV Sahlgrenska University Hospital, Gothenburg, Sweden
J. Turczynski
Affiliation:
Dept. of Developmental, Psychotic and Geriatric Psychiatry, Medical University of Gdansk, Gdanks, Poland
E. Smeraldi
Affiliation:
Dipartimento di Scienze Neuropsichiatriche, Facoltà die Medicina Università Vita-Salute San Raffaele, Milano, Italy

Abstract

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Objective

To explore changes in functioning with flexible doses of paliperidone ER in a large international study in patients with schizophrenia previously unsuccessfully treated with other oral antipsychotics.

Methods

Prospective 6-month open-label study. Functioning was assessed using the Personal and Social Performance Scale (PSP), including four domains:

  1. (1) personal and social relationships,

  2. (2) socially useful activities including work and study,

  3. (3) self care and

  4. (4) disturbing and aggressive behavior.

Results

1812 patients were included (59.9% male, mean age 40.1±12.6 years, 75.8% paranoid schizophrenia); most were enrolled because of lack of efficacy (n=1026) or lack of tolerability (n=490) with prior antipsychotic treatment. The median mode dose of paliperidone ER was 6 mg/day. 70.7% of patients completed the study. Most frequent reasons for early discontinuation were patient choice (8.8%), lack of efficacy or adverse event (5.1% each). AEs reported in >= 5% of patients were insomnia (9.2%) and anxiety (7.2%). Mean total baseline PSP score was 57.7±14.5, which improved to 64.1±15.6 at endpoint (mean change +6.4±13.5; 95% confidence interval 5.8;7.0, p< 0.0001); 49.0% of patients improved by at least one 10-point category in PSP. At baseline, 84.3% of patients had moderate to severe functional impairment, mostly driven by at least marked difficulties in socially useful activities (46.4.%) and personal and social relationships (36.4%). These percentages decreased to 30.6% and 22.9%, respectively.

Conclusion

In this large prospective flexible-dose study, results from recent randomized controlled studies are supported that paliperidone ER is associated with a clinically meaningful improvement of functioning in patients with schizophrenia.

Type
Psychotic disorders / Schizophrenia
Information
European Psychiatry , Volume 25 , Issue S1: 18th European Congress of Psychiatry. February 27, March 2, 2010 - Munich, Germany , 2010 , 25-E1095
Copyright
Copyright © European Psychiatric Association 2010
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