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European Psychiatry
Sous presse. Epreuves corrigées par l'auteur. Disponible en ligne depuis le mercredi 14 septembre 2011
Doi : 10.1016/j.eurpsy.2011.06.008
Received : 19 February 2010 ;  accepted : 28 June 2011
A prospective, multicentre, open-label study to evaluate the effectiveness of aripiprazole in the treatment of a broad range of patients with schizophrenia
 

J. Peuskens a, , C. Bervoets b, F. Kok c, B. Delatte d, G. Touquet e, B. Gillain f, A. de Patoul g, V. Halkin g, J.-Y. Loze h, K. Vansteelandt a, E. Constant i
a Universitair Centrum Sint Jozef, Kortenberg, Belgium 
b Polykliniek Onze Lieve Vrouw Sint Michiels, Brugge, Belgium 
c MSOURCE, Lange Dreef 11H, 4131 NJ Vianen, The Netherlands 
d Institut psychiatrique du Beau-Vallon, Saint-Servais, Belgium 
e Psychiatrisch Ziekenhuis Heilig Hart, Ieper, Belgium 
f Cliniques Saint-Pierre, Ottignies, Belgium 
g Bristol-Myers Squibb, parc de l’Alliance, Braine-l’Alleud, Belgium 
h Otsuka pharmaceutical, Rueil-Malmaison cedex, France 
i Cliniques universitaires Saint-Luc, Bruxelles, Belgium 

Corresponding author. Tel.: +32 2 758 05 46; fax: +32 2 758 18 78.
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.


Keywords : Aripiprazole, Effectiveness, Schizophrenia




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