Flexible dosing with paliperidone ER in the treatment of patients with acutely exacerbated schizophrenia: results from a single-arm, open-label study

Abstract Objective:To extend findings from fixed-dose, double-blind, placebo-controlled clinical trials in selected patient populations by using flexibly-dosed oral paliperidone extended-release (ER) in a more naturalistic setting. Methods:Adults hospitalized with an acute exacerbation of schizophre...

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Bibliographic Details
Published in:Current medical research and opinion 2012-08, Vol.28 (8), p.1395-1404
Main Authors: Schmauss, Max, Juki, Vlado, Siracusano, Alberto, Bidzan, Leszek, Badescu, George M., Maciulis, Valentinas, Lahaye, Marjolein, Hoeben, Dagmar, Tessier†, Christophe, Schreiner, Andreas
Format: Article
Language:English
Subjects:
Acute Disease
Adolescent
Adult
Aged
Antipsychotic Agents - administration & dosage
Antipsychotic Agents - adverse effects
Delayed-Action Preparations - administration & dosage
Delayed-Action Preparations - adverse effects
Disease Progression
Dose-Response Relationship, Drug
Double-Blind Method
Extended release
Female
Flexible dosing
Humans
Isoxazoles - administration & dosage
Isoxazoles - adverse effects
Male
Middle Aged
Paliperidone
Paliperidone Palmitate
Precision Medicine
Pyrimidines - administration & dosage
Pyrimidines - adverse effects
Randomized Controlled Trials as Topic
Schizophrenia
Schizophrenia - drug therapy
Young Adult
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Summary:Abstract Objective:To extend findings from fixed-dose, double-blind, placebo-controlled clinical trials in selected patient populations by using flexibly-dosed oral paliperidone extended-release (ER) in a more naturalistic setting. Methods:Adults hospitalized with an acute exacerbation of schizophrenia were prospectively treated with open-label flexibly-dosed paliperidone ER 3-12 mg/day for 6 weeks. Results:Overall, 294 patients were treated. The primary endpoint, defined as ≥30% improvement in Positive and Negative Syndrome Scale total scores from baseline to endpoint, was achieved by 66.3% of patients. The percentage of patients rated as at least 'markedly ill' in Clinical Global Impression of Severity scale decreased from baseline (74.1%) to endpoint (20.0%). Patient functioning, assessed by the Personal and Social Performance scale, improved significantly from 50.0 ± 14.3 at baseline to 63.6 ± 14.9 at endpoint (p 
ISSN:0300-7995
1473-4877
DOI:10.1185/03007995.2012.708327