A multicenter, randomized, double-blind, controlled phase 3 trial of fixed-dose brexpiprazole for the treatment of adults with acute schizophrenia

Kane, John M.; Skuban, Aleksandar; Ouyang, John; Hobart, Mary; Pfister, Stephanie; McQuade, Robert D.; Nyilas, Margaretta; Carson, William H.; Sanchez, Raymond; Eriksson, Hans

doi:10.1016/j.schres.2015.01.038

Cited by 289 publications

(178 citation statements)

References 33 publications

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“…Up to half of the patients responded to this dose. 1,2 In a longer term placebo-controlled trial, brexpiprazole reduced the risk of relapse in patients already established on brexpiprazole. 4 As with …”

Section: New Drugsmentioning

confidence: 99%

“…Two six-week randomised, placebo-controlled trials investigated the safety and efficacy of brexpiprazole in 1310 patients with acute schizophrenia (see Table). 1,2 The primary outcome measure was improvement on the Positive and Negative Syndrome Scale (PANSS). This is a 30-item scale assessing positive (e.g.…”

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confidence: 99%

“…1 However, in the other trial, only the 4 mg/day dose was significantly better than placebo. 2 Another efficacy measure was response rate. This was defined as the proportion of patients with a ≥30% improvement in their PANSS score or Clinical Global Impression (CGI) score.…”

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confidence: 99%

“…In the trials, 46.1-49.7% of patients had responded to the 4 mg/day dose compared with 30.3-31.7% in the placebo groups (see Table). 1,2 In another trial, flexible doses of open-label brexpiprazole (1-4 mg/day) and aripiprazole (10-20 mg/day) were compared in 97 patients with acute schizophrenia. After six weeks of treatment, mean changes in PANSS scores with brexpiprazole were comparable to aripiprazole (see Table).…”

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New drug: Brexpiprazole for schizophrenia

2017

Aust Prescr

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Section: New Drugsmentioning

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confidence: 99%

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New drug: Brexpiprazole for schizophrenia

2017

Aust Prescr

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“…This profile has become a favored model for developing new APDs with familiar mechanisms, including asenapine, blonanserin, brexpiprazole, cariprazine, iloperidone, [27]. The results of 6-week phase III RCT of 674 patients with an acute episode of schizophrenia demonstrated that treatment with brexpiprazole (4 mg/day) showed superior improvement in psychopathological symptoms compared with placebo [28]. Brexpiprazole was well tolerated and, the most common treatmentemergent adverse events were headache, insomnia, and agitation.…”

Section: New Drugs With Familiar Mechanismsmentioning

confidence: 99%

Pharmacological Treatment of Schizophrenia:

Fleischhacker

Miyamoto

2016

CNPT

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In the past decade, four main topics have shaped research and clinical practice. 1) In randomized controlled trials, researchers have investigated whether treating prodromal symptoms of schizophrenia helps to reduce the conversion risk to full-blown schizophrenia. Results are ambiguous and the discussion on whether or not an intervention at the stage is justified is ongoing. 2) Following the enhanced understanding of the pathophysiology of schizophrenia, also with respect to specific symptom domains, pharmacological targets beyond D 2 receptor antagonism have been explored. Much work and enthusiasm has revolved around nicotinergic and glutamatergic compounds, so far with mostly discouraging results. 3) Several new-generation antipsychotics have become available as long-acting formulations. All of them have demonstrated a significant positive impact on relapse rates in placebo controlled studies. Whether these compounds also have advantages over first-generation depots and/or oral antipsychotics is still debated. The development of an inhalable antipsychotic has complemented the treatment options for the management of acutely agitated patients. 4) Lastly, attempts from various perspectives, including genetics and neuroimaging, have investigated whether it is possible to predict treatment response and drug safety. Although some look promising, they have not yet reached a stage in which they can be applied to everyday clinical practice. What has become clear, though, is that early non response predicts late non response, leading to the recommendation to switch antipsychotics much earlier than stated in most treatment guidelines.

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