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A prospective, multicentre, open-label study to evaluate the effectiveness of aripiprazole in the treatment of a broad range of patients with schizophrenia

Published online by Cambridge University Press:  15 April 2020

J. Peuskens*
Affiliation:
Universitair Centrum Sint Jozef, Kortenberg, Belgium
C. Bervoets
Affiliation:
Polykliniek Onze Lieve Vrouw Sint Michiels, Brugge, Belgium
F. Kok
Affiliation:
MSOURCE, Lange Dreef 11H, 4131 NJ Vianen, The Netherlands
B. Delatte
Affiliation:
Institut psychiatrique du Beau-Vallon, Saint-Servais, Belgium
G. Touquet
Affiliation:
Psychiatrisch Ziekenhuis Heilig Hart, Ieper, Belgium
B. Gillain
Affiliation:
Cliniques Saint-Pierre, Ottignies, Belgium
A. de Patoul
Affiliation:
Bristol-Myers Squibb, parc de l’Alliance, Braine-l’Alleud, Belgium
V. Halkin
Affiliation:
Bristol-Myers Squibb, parc de l’Alliance, Braine-l’Alleud, Belgium
J.-Y. Loze
Affiliation:
Otsuka pharmaceutical, Rueil-Malmaison cedex, France
K. Vansteelandt
Affiliation:
Universitair Centrum Sint Jozef, Kortenberg, Belgium
E. Constant
Affiliation:
Cliniques universitaires Saint-Luc, Bruxelles, Belgium
*
*Corresponding author. Tel.: +32 2 758 05 46; fax: +32 2 758 18 78. E-mail address:[email protected]
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Abstract

Purpose

The aim of this study is to evaluate the effectiveness of 12-week treatment with aripiprazole in a broad range of patients suffering from schizophrenia by using a variety of physicians, caregivers and patients scales.

Subjects and methods

A total of 361 in- or outpatients who met Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria for schizophrenia received open-label aripiprazole (10–30mg per day) in this 12-week, prospective, multicentre, uncontrolled study. The primary endpoint was the Clinical Global Impression-Improvement (CGI-I) scale which measured effectiveness of study medication, including efficacy, safety and tolerability. A variety of physician-, patient- and caregiver-rated parameters were measured to gain a complete view of the effectiveness of aripiprazole.

Results

The effectiveness of aripiprazole treatment was demonstrated in a broad range of schizophrenia patients (CGI-I score of 3.0; 95% confidence interval: 2.8, 3.2: last observation carried forward [LOCF]) as the upper bound of the 95% CI was less than 4 (score of “no change”). Both patient and caregiver PGI-I scores (LOCF: 95% CI: 2.79, 3.09 and, 95% CI: 2.74, 3.17, respectively) corroborate this finding. Aripiprazole had a positive effect on disease severity by study end, as assessed by an increase of the (physician-rated) CGI-S scores, with 57.3% of patients having improved disease, one-third maintaining their condition (30.8%) and 11.3% with worsening symptoms (LOCF). The Investigator Assessment Questionnaire (IAQ) showed a great improvement (>50% of patients). Patients reported significantly improved quality of life and overall, 71% of patients and 67% of caregivers preferred aripiprazole to their previous antipsychotic medication (LOCF; P<0.0001 over time).

Conclusion

Aripiprazole was effective in a broad range of patients with schizophrenia.

Type
Original articles
Copyright
Copyright © European Psychiatric Association 2012

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