Efficacy and Tolerability of Aripiprazole: A 26-Week Switching Study from Oral Antipsychotics

Objective To determine if the maintenance effectiveness and tolerability of aripiprazole demonstrated in a 12-week study were maintained in an extension phase (up to 26 weeks). Methods This study was the extension of our switching study from other antipsychotics to aripiprazole in symptomatically stable patients with schizophrenia or schizoaffective disorder. All the patients were randomly assigned to the aripiprazole group or the non-aripiprazole group. The effectiveness analysis consisted of the comparison of the upper bound of the 95% confidence interval (CI) of the mean Clinical Global Impression-Improvement (CGI-I) score to 4 (no change) at the end of the study. Results At the baseline, the aripiprazole group (n=135) and the non-aripiprazole group (n=31) were comparable with respect to their mean ages, gender distribution, baseline Positive and Negative Syndrome Scale scores, and Clinical Global Impression-Severity (CGI-S) scores. The study showed that the mean CGI-I score was 2.92 (95% CI: 2.72-3.12) in the aripiprazole group and 2.81 (95% CI: 2.35-3.26) in the non-aripiprazole group at 26 weeks. In the aripiprazole group, the remission rates at 12 and 26 weeks were 74.8% and 72.6%, respectively, and 80.2% of the patients with remission at 12 weeks maintained their remission state until the end of the study. About one-fourth of the patients in the aripiprazole group reported one or more spontaneous treatment-emergent adverse events, such as insomnia, headache, and nausea. Conclusion This study suggested that most clinically stable outpatients with schizophrenia maintain their remission states after being switched to aripiprazole, without serious symptom aggravation and adverse events over a course of 26 weeks. Psychiatry Investig 2010;7:189-195This study was supported by Korea Otsuka Pharmaceuticals (KOP 010402).Kim CY, 2009, INT CLIN PSYCHOPHARM, V24, P181, DOI 10.1097/YIC.0b013e32832c25d7Kolotkin RL, 2008, EUR PSYCHIAT, V23, P561, DOI 10.1016/j.eurpsy.2008.01.1421Findling RL, 2008, AM J PSYCHIAT, V165, P1432, DOI 10.1176/appi.ajp.2008.07061035Tandon R, 2008, SCHIZOPHR RES, V100, P20, DOI 10.1016/j.schres.2007.11.033Wolf J, 2007, CURR MED RES OPIN, V23, P2313, DOI 10.1185/030079907X225448Moeller KE, 2006, J CLIN PSYCHIAT, V67, P1942Chrzanowski WK, 2006, PSYCHOPHARMACOLOGY, V189, P259, DOI 10.1007/s00213-006-0564-3Tandon R, 2006, SCHIZOPHR RES, V84, P77, DOI 10.1016/j.schres.2005.12.857Lieberman JA, 2005, NEW ENGL J MED, V353, P1209Kim CY, 2005, J CLIN PSYCHIAT, V66, P887Kasper S, 2003, INT J NEUROPSYCHOPH, V6, P325, DOI 10.1017/S1461145703003651Pigott TA, 2003, J CLIN PSYCHIAT, V64, P1048Potkin SG, 2003, ARCH GEN PSYCHIAT, V60, P681Marder SR, 2003, SCHIZOPHR RES, V61, P123, DOI 10.1016/S0920-9964(03)00050-1Kane JM, 2002, J CLIN PSYCHIAT, V63, P763WEIDEN PJ, 1995, SCHIZOPHRENIA BULL, V21, P419