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The Effect of Brexpiprazole (OPC-34712) and Aripiprazole in Adult Patients with Acute Schizophrenia: Results from a Randomized, Exploratory Study

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The Effect of Brexpiprazole (OPC-34712) and Aripiprazole in Adult Patients with Acute Schizophrenia: Results from a Randomized, Exploratory Study 192 Original article The effect of brexpiprazole (OPC-34712) and aripiprazole in adult patients with acute schizophrenia: results from a randomized, exploratory study Leslie Citromea,AiOtac, Kazuhiro Nagamizuc, Pamela Perryb, Emmanuelle Weillerd and Ross A. Bakerb The aim of this study was to explore the effects of (9.4%) than aripiprazole (21.2%). Clinically relevant brexpiprazole and aripiprazole on efficacy, cognitive improvements in psychopathology were observed in functioning, and safety in patients with acute schizophrenia. patients with acute schizophrenia treated with Patients who would benefit from hospitalization/continued brexpiprazole or aripiprazole. Brexpiprazole was well hospitalization for acute relapse of schizophrenia were tolerated, with a lower incidence of akathisia than enrolled and randomized (2 : 1) to target doses of open- aripiprazole. Int Clin Psychopharmacol 31:192–201 label brexpiprazole 3 mg/day or aripiprazole 15 mg/day for Copyright © 2016 Wolters Kluwer Health, Inc. All rights 6 weeks. Outcomes included change from baseline to week reserved. 6 in the Positive and Negative Syndrome Scale total score, International Clinical Psychopharmacology 2016, 31:192–201 Barratt Impulsiveness Scale 11-item score, and Cogstate computerized cognitive test battery scores. Patients treated Keywords: akathisia, antipsychotic, aripiprazole, Barratt Impulsiveness Scale 11-item, brexpiprazole, Positive and Negative Syndrome Scale, with brexpiprazole (n = 64) or aripiprazole (n = 33) showed schizophrenia, Specific Levels of Functioning Scale reductions in symptoms of schizophrenia as assessed by aDepartment of Psychiatry and Behavioural Sciences, New York Medical College, Positive and Negative Syndrome Scale total score (− 22.9 Valhalla, New York, bOtsuka Pharmaceutical Development & and − 19.4, respectively). A modest reduction in impulsivity Commercialization Inc., Princeton, New Jersey, USA, cOtsuka Pharmaceutical Co. Ltd, Tokyo, Japan and dH. Lundbeck A/S, Valby, Denmark was observed with brexpiprazole, but not aripiprazole (mean change in the Barratt Impulsiveness Scale 11-item Correspondence to Leslie Citrome, MD, MPH, 11 Medical Park Drive, Suite 106, Pomona, NY 10970, USA total score: − 2.7 and 0.1, respectively). No change in Tel: + 1 845 362 2081; fax: + 1 845 362 8745; Cogstate scores was observed for either treatment. e-mail: [email protected] Brexpiprazole was well tolerated and the incidence of Received 21 October 2015 Accepted 2 February 2016 akathisia was lower in patients treated with brexpiprazole Introduction Schizophrenia, in general, remains a complex and Schizophrenia is a chronic and debilitating mental illness difficult-to-treat disorder, despite the number of different (Volavka and Citrome, 2009). Individuals with schizo- antipsychotics commercially available (Volavka and phrenia experience a range of impairments, including Citrome, 2009; Citrome, 2013). Meta-analyses have positive (e.g. hallucinations, delusions), negative (e.g. shown that when comparing groups of patients enrolled social withdrawal, lack of emotion, apathy), and cognitive in clinical trials, first-line second-generation anti- (e.g. memory, attention, problem solving) symptoms psychotics can differ considerably in reported side (Volavka and Citrome, 2009; Levi et al., 2013). Another effects, with smaller differences observed in efficacy (De symptom domain of schizophrenia includes impulsive Hert et al., 2012a; Citrome, 2013; Leucht et al., 2013; behaviors, agitation, and hostility (Citrome, 2007; Ouzir, Citrome and Volavka, 2014). Importantly, efficacy and 2013; Reddy et al., 2014). Schizophrenia not only has a tolerability responses to different antipsychotics can vary profound detrimental effect on the patient’s well-being markedly among individual patients in clinical practice and ability to function in society but also a cost burden of (Citrome, 2013). more than $62 billion per year in the USA (Saha et al., Antipsychotic drugs bind to a variety of dopaminergic, 2005; Wu et al., 2005; Volavka and Citrome, 2009). serotonergic, noradrenergic, histaminic, and muscarinic receptors. Their affinity and intrinsic activity for the D2 Supplemental digital content is available for this article. Direct URL citations receptor varies, with effective blockade being achieved at appear in the printed text and are provided in the HTML and PDF versions of this different dose levels, often resulting in drug concentra- article on the journal's website (www.intclinpsychopharm.com). tions that can lead to the blockade of other receptor This is an open-access article distributed under the terms of the Creative systems, potentially triggering associated side effects Commons Attribution-Non Commercial-No Derivatives License 4.0 (CCBY-NC- ND), where it is permissible to download and share the work provided it is properly (Correll, 2010). The different receptor-binding profiles of cited. The work cannot be changed in any way or used commercially. current second-generation antipsychotics may contribute 0268-1315 Copyright © 2016 Wolters Kluwer Health, Inc. All rights reserved. DOI: 10.1097/YIC.0000000000000123 Brexpiprazole and aripiprazole in acute schizophrenia Citrome et al. 193 toward the variability in accompanying side effects with those of aripiprazole (Maeda et al., 2014b). (Correll, 2010), including weight gain, sedation, rest- Furthermore, brexpiprazole showed statistically sig- lessness/agitation, akathisia, QTc prolongation, extra- nificant efficacy and good tolerability compared with pyramidal symptoms (EPSs), and hyperprolactinemia placebo in two recent phase III clinical studies in adult (and associated sexual effects) (Kane et al., 2010; De Hert patients with acute schizophrenia (Correll et al., 2015; et al., 2012b; Leucht et al., 2013). Therefore, selection of Kane et al., 2015). Systematic clinical reviews can be an effective antipsychotic for a patient requires careful found elsewhere (Citrome, 2015a, 2015b). consideration of the agent’s full efficacy and safety profile The aim of this open-label study (ClinicalTrials.gov (Citrome and Volavka, 2014). Antipsychotic treatment NCT02054702) was to explore changes in efficacy, cog- selection requires the careful balancing of activating and nitive functioning, and safety of a 6-week treatment with sedating side effects, as well as minimizing the risk for flexibly-dosed brexpiprazole or aripiprazole monotherapy EPSs, metabolic, and cardiovascular events associated in patients with schizophrenia. Aripiprazole was included with various antipsychotic agents. as a positive control to confirm assay sensitivity in Brexpiprazole (OPC-34712) is a serotonin-dopamine this study. activity modulator (Maeda et al., 2014a). It acts as a par- tial agonist at the serotonin 5-HT1A and dopamine D2 Patients and methods receptors, and as an antagonist at 5-HT2A and nora- Patients drenaline α1B/2C receptors (Maeda et al., 2014a), with Adult patients (18–65 years old) with a Diagnostic and similar affinity at all 5 receptors. As reward capacity can statistical manual of mental disorders, 4th ed., text revision be diminished by pure D2 full antagonists, partial D2 (DSM-IV-TR) diagnosis of schizophrenia that was con- agonists may preserve reward capacity mediated by D2 firmed by the Mini International Neuropsychiatric receptors and thus contribute toward improved patient Interview for Schizophrenia and Psychotic Disorders functioning and autonomy (Stahl, 2008). Both brexpi- (Sheehan et al., 1998) were recruited to participate. prazole and aripiprazole (available commercially since Patients were eligible if, in the investigator’s opinion, 2002) are second-generation antipsychotics that act as they might potentially benefit from hospitalization or partial agonists at D2 and serotonin 5-HT1A receptors and continued hospitalization with brexpiprazole or aripipra- as antagonists at the 5-HT2A receptor (Shapiro et al., zole monotherapy for the treatment of a current acute 2003; Maeda et al., 2014a). However, aripiprazole has relapse of schizophrenia. Patients had to be experiencing been associated with inducing D2 agonist-mediated an acute exacerbation of psychotic symptoms and marked adverse events (AEs) such as akathisia, insomnia, rest- deterioration of usual function as shown by all of the lessness, agitation, and nausea (Fleischhacker, 2005; following: Positive and Negative Syndrome Scale Otsuka Pharmaceutical Co. Ltd, 2016). (PANSS) (Kay et al., 1987) total score of 80 or more; score of 4 or more at screening on two or more PANSS items of Brexpiprazole has a lower intrinsic activity at the D 2 hallucinatory behavior, unusual thought content, con- receptor than aripiprazole, and as such should induce ceptual disorganization, or suspiciousness; and Clinical fewer D agonist-mediated AEs. In addition, brexpipra- 2 Global Impression-Severity of Illness Scale (CGI-S) score zole has a higher affinity at the 5-HT receptor than 2A 4 or more (moderately ill). Patients were excluded if they aripiprazole and as 5-HT antagonism may reduce D 2A 2 were presenting with a first episode of schizophrenia, had antagonist-induced akathisia (Laoutidis and Luckhaus, been hospitalized for more than 21 days for the current 2014), brexpiprazole may have the potential to be asso- acute episode, had a current DSM-IV-TR Axis 1 diag- ciated with fewer EPS-related events compared with nosis other than schizophrenia, or they showed an aripiprazole. Brexpiprazole also shows higher affinity for improvement of 20% or more in the
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