ArticleNeurology and therapy2026
Clinical Outcomes Among Patients with Major Depressive Disorder with Hyperarousal Symptoms Taking Brexpiprazole as Augmentation to Antidepressant Treatment in a United States Real-World Setting.
Article in Neurology and therapy, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
introductionSymptoms of hyperarousal, such as trouble concentrating, insomnia, irritability, and hypervigilance, are increasingly recognized as important features of major depressive disorder (MDD). Brexpiprazole is an atypical antipsychotic approved in the US for the treatment of MDD as adjunctive therapy to antidepressant treatment in adults. The aim of this analysis was to evaluate the effect of brexpiprazole on depressive symptoms in patients with MDD and symptoms of hyperarousal in a real-world cohort.
methodsThis is an analysis of a subset of patients with hyperarousal from a retrospective, observational cohort study of adults with MDD who initiated brexpiprazole treatment between 2015 and 2023 as augmentation to an antidepressant. The study used de-identified linked data from electronic medical records and claims from community-based practices across the US. A natural language processing approach was used to identify patients with symptoms of hyperarousal (trouble concentrating, insomnia, irritability, and/or hypervigilance) from unstructured clinical notes. Patients with symptoms of mania/grandiosity, potentially reflecting undiagnosed bipolar disorder, were excluded. The primary outcome was the change in 9-item Patient Health Questionnaire (PHQ-9) score.
resultsOf the total cohort (N = 1073), 1069 patients had sufficient data to evaluate hyperarousal symptoms, and 575/1069 patients (53.8%) met the criteria for presence of hyperarousal symptoms (with no mania/grandiosity), most commonly irritability and/or insomnia. The mean age at baseline was 48.8 years, 77.4% of patients were female, and the mean (SD) PHQ-9 score at baseline was 11.7 (5.9). The mean improvement in PHQ-9 score from baseline to Month 12 was - 2.7 (95% CI - 3.2 to - 2.2; p < 0.001).
conclusionIn this large real-world cohort of patients with MDD and symptoms of hyperarousal who received adjunctive brexpiprazole, symptoms of depression improved over 12 months.
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