INTRODUCTION:Efficacy and safety of aripiprazole administered at doses lower than those previously studied systematically were investigated in patients with acute exacerbation of schizophrenia. METHODS: In this double-blind, multicenter study, 367 patients requiring inpatient hospitalization for acute relapse of schizophrenia were randomized to one of three fixed doses of aripiprazole (2, 5, or 10 mg/day) or placebo for 6 weeks. Efficacy and safety parameters were assessed weekly. Primary outcome measure was mean change from baseline in Positive and Negative Syndrome Scale (PANSS) Total score at endpoint. RESULTS:Aripiprazole 10 mg/day produced statistically significantly greater improvements from baseline compared with placebo for PANSS Total at endpoint (-11.3 vs -5.3; P=.03) and at weeks 2-5. Aripiprazole 5 mg/day did not produce significantly greater improvement in PANSS Total compared with placebo at endpoint, although significant differences were seen at weeks 3-5. No statistically significant improvements compared with placebo were achieved with aripiprazole 2 mg/day at any time points. All aripiprazole doses were well tolerated. Aripiprazole was not associated with significant extrapyramidal symptoms. CONCLUSION: While aripiprazole 5 mg/day warrants further study, the 10 mg/day dose provides effective and well-tolerated therapy for management of acute psychosis in patients with schizophrenia.
RCT Entities:
INTRODUCTION: Efficacy and safety of aripiprazole administered at doses lower than those previously studied systematically were investigated in patients with acute exacerbation of schizophrenia. METHODS: In this double-blind, multicenter study, 367 patients requiring inpatient hospitalization for acute relapse of schizophrenia were randomized to one of three fixed doses of aripiprazole (2, 5, or 10 mg/day) or placebo for 6 weeks. Efficacy and safety parameters were assessed weekly. Primary outcome measure was mean change from baseline in Positive and Negative Syndrome Scale (PANSS) Total score at endpoint. RESULTS:Aripiprazole 10 mg/day produced statistically significantly greater improvements from baseline compared with placebo for PANSS Total at endpoint (-11.3 vs -5.3; P=.03) and at weeks 2-5. Aripiprazole 5 mg/day did not produce significantly greater improvement in PANSS Total compared with placebo at endpoint, although significant differences were seen at weeks 3-5. No statistically significant improvements compared with placebo were achieved with aripiprazole 2 mg/day at any time points. All aripiprazole doses were well tolerated. Aripiprazole was not associated with significant extrapyramidal symptoms. CONCLUSION: While aripiprazole 5 mg/day warrants further study, the 10 mg/day dose provides effective and well-tolerated therapy for management of acute psychosis in patients with schizophrenia.
Authors: Ragy R Girgis; David B Merrill; Stanislav R Vorel; Min You; Andrei Pikalov; Richard Whitehead; Jeffrey A Lieberman Journal: J Psychiatr Res Date: 2010-10-09 Impact factor: 4.791
Authors: Bret R Rutherford; Emily Pott; Jane M Tandler; Melanie M Wall; Steven P Roose; Jeffrey A Lieberman Journal: JAMA Psychiatry Date: 2014-12-01 Impact factor: 21.596
Authors: Robert W Buchanan; Julie Kreyenbuhl; Deanna L Kelly; Jason M Noel; Douglas L Boggs; Bernard A Fischer; Seth Himelhoch; Beverly Fang; Eunice Peterson; Patrick R Aquino; William Keller Journal: Schizophr Bull Date: 2009-12-02 Impact factor: 9.306