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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 ,
C. Bervoets ,
F. Kok ,
B. Delatte ,
G. Touquet ,
B. Gillain ,
A. de Patoul ,
V. Halkin ,
J.-Y. Loze  and
K. Vansteelandt
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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.

Keywords

AripiprazoleEffectivenessSchizophrenia
Type
Original articles
Information
European Psychiatry , Volume 27 , Issue 7 , October 2012 , pp. 506 - 512
Copyright
Copyright © European Psychiatric Association 2012

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References

American Psychiatric Association Diagnostic and Statistical Manual of Mental Disorders. 4th ed. Text revision.Washington, DC: American Psychiatric Association; 2000.Google Scholar
Burris, K.D.Molski, T.F.Xu, C.Ryan, E.Tottori, K.Kikuchi, T.et al.Aripiprazole, a novel antipsychotic, is a high-affinity partial agonist at human dopamine D2 receptors. J Pharmacol Exp Ther. 2002; 302: 381–389.CrossRefGoogle ScholarPubMed
Chrzanowski, W.K.Marcus, R.N.Torbeyns, A.Nyilas, M.McQuade, R.D.Effectiveness of long-term aripiprazole therapy in patients with acutely relapsing or chronic, stable schizophrenia: a 52-week, open-label comparison with olanzapine. Psychopharmacology (Berl). 2006; 189: 259–266.CrossRefGoogle ScholarPubMed
Demyttenaere, K.Desaiah, D.Petit, C.Croenlein, J.Brecht, S.Patient-assessed versus physician-assessed disease severity and outcome in patients with non-specific pain associated with major depressive disorder. Prim Care Companion J Clin Psychiatry. 2009; 11: 8–15.CrossRefGoogle Scholar
Endicott, J.Nee, J.Harrison, W.Blumenthal, R.Quality of Life Enjoyment and Satisfaction Questionnaire: a new measure. Psychopharmacol Bull. 1993; 29: 321–326.Google ScholarPubMed
Guy W. Early Clinical Drug Evaluation Unit (ECDEU) assessment manual for psychopharmacology. Revised. NIMH publication DHEW publ NO (Adm) 76-338. Bethesda MD: National Institute of Mental Health; 1976.CrossRefGoogle Scholar
Hirose, T.Uwahodo, Y.Yamada, S.Miwa, T.Kikuchi, T.Kitagawa, H.et al.Mechanism of action of aripiprazole predicts clinical efficacy and a favourable side-effect profile. J Psychopharmacol. 2004; 18: 375–383.CrossRefGoogle Scholar
Hogan, T.P.Awad, A.G.Eastwood, R.A self-report scale predictive of drug compliance in schizophrenics: reliability and discriminative validity. Psychol Med. 1983; 13: 177–183.CrossRefGoogle ScholarPubMed
Jordan, S.Koprivica, V.Chen, R.Tottori, K.Kikuchi, T.Altar, C.A.The antipsychotic aripiprazole is a potent, partial agonist at the human 5-HT(1A) receptor. Eur J Pharmacol. 2002; 441: 137–140.CrossRefGoogle ScholarPubMed
Jordan, S.Koprivica, V.Dunn, R.Tottori, K.Kikuchi, T.Altar, C.A.In vivo effects of aripiprazole on cortical and striatal dopaminergic and serotonergic function. Eur J Pharmacol. 2004; 483: 45–53.CrossRefGoogle ScholarPubMed
Kane, J.M.Carson, W.H.Saha, A.R.McQuade, R.D.Ingenito, G.G.Zimbroff, D.L.et al.Efficacy and safety of aripiprazole and haloperidol versus placebo in patients with schizophrenia and schizoaffective disorder. J Clin Psychiatry. 2002; 63: 763–771.CrossRefGoogle ScholarPubMed
Kane J, Carson W, Kujawa M. Aripiprazole vs perphenazine in treatment-resistant schizophrenia. Presented at 156th Annual Meeting of the American Psychiatric Association, Toronto, Canada, August 7–10, 2003.Google Scholar
Kasper, S.Lerman, M.N.McQuade, R.D.Saha, A.Carson, W.H.Ali, M.et al.Efficacy and safety of aripiprazole vs haloperidol for long-term maintenance treatment following acute relapse of schizophrenia. Int J Neuropsychopharmacol. 2003; 6: 325–337.CrossRefGoogle ScholarPubMed
Kerwin, R.Millet, B.Herman, E.Banki, C.M.Lublin, H.Pans, M.et al.A multicentre, randomized, naturalistic, open-label study between aripiprazole and standard of care in the management of community-treated schizophrenic patients. Schizophrenia Trial of Aripiprazole: (STAR) Study. Eur Psychiatry. 2007; 22: 433–443.CrossRefGoogle ScholarPubMed
Marder, S.R.McQuade, R.D.Stock, E.Kaplita, S.Marcus, R.Safferman, A.Z.et al.Aripiprazole in the treatment of schizophrenia: safety and tolerability in short-term, placebo-controlled trials. Schizophr Res. 2003; 61: 123–136.CrossRefGoogle ScholarPubMed
McQuade, RDKostic, DMarcus, RCarson, WHIwamoto, TTorbeyns, AF et al. Aripiprazole versus olanzapine in schizophrenia: a 52-week, open-label extension study in American College of Neuropsychopharmacology; 2004.Google Scholar
Millan, M.J.Improving the treatment of schizophrenia: focus on serotonin (5-HT)(1A) receptors. J Pharmacol Exp Ther. 2000; 295: 853–861.Google ScholarPubMed
Petrie, J.L.Saha, A.R.McEvoy, J.P.Aripiprazole, a new antipsychotic: phase II clinical trial results. Eur Neuropsychopharmacol. 7 Suppl 2 1997 S227.CrossRefGoogle Scholar
Pigott, T.A.Carson, W.H.Saha, A.R.Torbeyns, A.F.Stock, E.G.Ingenito, G.G.Aripiprazole for the prevention of relapse in stabilized patients with chronic schizophrenia: a placebo-controlled 26-week study. J Clin Psychiatry. 2003; 64: 1048–1056.CrossRefGoogle ScholarPubMed
Potkin, S.G.Saha, A.R.Kujawa, M.J.Carson, W.H.Ali, M.Stock, E.et al.Aripiprazole, an antipsychotic with a novel mechanism of action, and risperidone vs placebo in patients with schizophrenia and schizoaffective disorder. Arch Gen Psychiatry. 2003; 60: 681–690.CrossRefGoogle ScholarPubMed
Shapiro, D.A.Renock, S.Arrington, E.Chiodo, L.A.Liu, L.X.Sibley, D.R.et al.Aripiprazole, a novel atypical antipsychotic drug with a unique and robust pharmacology. Neuropsychopharmacol. 2003; 28: 1400–1411.CrossRefGoogle ScholarPubMed
Tandon, R.Devellis, R.F.Han, J.Li, H.Frangou, S.Dursun, S.et al.Validation of the Investigator's Assessment Questionnaire, a new clinical tool for relative assessment of response to antipsychotics in patients with schizophrenia and schizoaffective disorder. Psychiatry Res. 2005; 136: 211–221.CrossRefGoogle ScholarPubMed
Tandon, R.Marcus, R.N.Stock, E.G.Riera, L.C.Kostic, D.Pans, M.et al.A prospective, multicenter, randomized, parallel-group, open-label study of aripiprazole in the management of patients with schizophrenia or schizoaffective disorder in general psychiatric practice: Broad Effectiveness Trial With Aripiprazole (BETA). Schizophr Res. 2006; 84: 77–89.CrossRefGoogle ScholarPubMed
Tohen, M.Zhang, F.Taylor, C.C.Burns, P.Zarate, C.Sanger, T.et al.A meta-analysis of the use of typical antipsychotic agents in bipolar disorder. J Affect Disord. 2001; 65: 85–93.CrossRefGoogle ScholarPubMed
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