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P03-128 - A Flexible-Dose Study of Paliperidone ER in Non-Acute Patients with Schizophrenia Previously Unsuccessfully Treated with Oral Risperidone

Published online by Cambridge University Press:  17 April 2020

A. Schreiner ,
D. Hoeben ,
M. Lahaye ,
T. Tzotzoras ,
J. Louvrier ,
L. Helldin ,
N. Dilbaz ,
D. Naber ,
L. Dembinskiene  and
C. Tessier
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
T. Tzotzoras
Affiliation:
Psycho-geriatric Dept. of the Mental Hospital of Thessaloniki, Thessaloniki Psychiatric Hospital, Thessaloniki, Greece
J. Louvrier
Affiliation:
Centre de Psychothérapie les Marronniers, Bully les Mines, France
L. Helldin
Affiliation:
Department of Psychiatry, NU Health Care, Trollhättan, Sweden
N. Dilbaz
Affiliation:
Second Psychology Clinic, Ankara Numune Training and Research Hospital, Ankara, Turkey
D. Naber
Affiliation:
Dept. for Psychiatry and Psychotherapy, Universitätsklinikum Hamburg-Eppendorf, Hamburg, Germany
L. Dembinskiene
Affiliation:
Vilnius City Mental Health Center, Vilnius, Lithuania
C. Tessier
Affiliation:
EMEA Medical Affairs, Janssen Cilag France, Paris, France

Abstract

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Objective

To explore tolerability, safety and treatment response of flexible doses of paliperidone ER in adult non-acute patients with schizophrenia previously unsuccessfully treated with oral risperidone.

Methods

International prospective 6-month open-label study. Endpoints were the Positive and Negative Syndrome Scale (PANSS), Clinical Global Impression-Severity Scale (CGI-S), adverse events (AEs), extrapyramidal symptoms (Extrapyramidal Symptom Rating Scale; ESRS) and weight change.

Results

694 patients were included (59.2% male, mean age 40.0±12.8 years, 74.8% paranoid schizophrenia); most were enrolled because of lack of efficacy (n=366) or lack of tolerability (n=178) with prior oral risperidone treatment. 74.1% of patients (n=514) completed the 6-month study. Most frequent reasons for early discontinuation were patient choice (7.3%) and lack of efficacy (5.2%). The median mode dose of paliperidone ER was 6 mg/day, independent of the reason for switching. For all patients, mean total PANSS decreased significantly from 78.6±20.5 at baseline to 65.6±22.5 at endpoint (mean change -13.0±19.4; 95% confidence interval -14.5;-11.5, p< 0.0001). The percentage of patients rated mildly ill or less in CGI-S increased from 28.3% to 52.5% at endpoint, and the rate of patients with mild functional impairment increased from 16.5% to 36.6%. AEs reported in greater-than-or-equal-to 5% of patients were insomnia (8.8%) and anxiety (7.3%). Extrapyramidal symptoms in ESRS decreased significantly from 3.8±6.1 to 2.3±5.1 (p< 0.0001). Mean weight gain from baseline to endpoint was 0.4±4.3kg.

Conclusion

These data support results from recent randomized controlled studies that paliperidone ER is safe, well tolerated and effective in patients previously unsuccessfully treated with oral risperidone.

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-E1097
Copyright
Copyright © European Psychiatric Association 2010
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