Analysis of Real-world Data Confirms Potential Benefit of Treatment for Major Depressive Disorder

April 4, 2023

A new analysis of real-world data recently published in ClinicoEconomics and Outcomes Research suggests that a treatment strategy of an atypical antipsychotic called brexpiprazole may help some patients with major depressive disorder who do not show improvement after taking traditional antidepressants.

The analysis, which was conducted jointly by Holmusk and Otsuka Pharmaceutical Development & Commercialization, Inc., drew a cohort of patients from Holmusk’s NeuroBlu Database, which contains rich real-world data on behavioral health conditions, treatments, and assessments. By identifying patients with a diagnosis of major depressive disorder who had received brexipiprazole during routine care, researchers were able to analyze real-world data to determine the treatment’s impact.

Innovative methodology

Historically, progress in behavioral health has been challenged by a gap between routine clinical care and clinical research, as well as a lack of standardized measurements to assess outcomes. Much of the information that providers collect during clinic appointments, such as when they administer an assessment called the Mental Status Examination, is stored in unstructured or semi-structured free text fields within the EHR. Because of the lack of structure, this information is not readily usable for research.

The study team accounted for these challenges and sought to close the gap between care and research by applying innovative methodology that converted these unstructured or semi-structured free text fields into a structured and quantifiable format. The transformation of this important information enabled the study team to make comparisons between patients. In addition, researchers used this new structured data to create an outcome measure that could help to quantify patients’ life engagement in four different domains: emotional, physical, social, and cognitive.

Important findings

Upon analysis of the new outcome measure for life engagement, researchers found statistically significant improvements in the cohort of patients who were treated with brexipiprazole. One fifth of patients showed improvement one month after starting the treatment, and by six months, that number rose to over half of patients. Patients showed most improvement in the emotional and social domains of life engagement.

“This study has important implications that could guide the care of patients who are not improving on a traditional treatment regimen of antidepressants,” said Heidi Waters, PhD, Senior Director of Policy Research at Otsuka Pharmaceutical Development & Commercialization, Inc. “We know that the literature shows that patients with this condition care greatly about life engagement, and symptoms related to diminished life engagement are often the reason people seek treatment.”

“This study is important because it uses real-world data to examine findings from post-hoc analyses of clinical trials,” said A. John Rush, MD, Holmusk’s Interim Chief Medical Officer. “The study was enabled by the NeuroBlu Database, Holmusk’s rich real-world data source that contains a high coverage of Mental Status Examination data, which we were able to structure and quantify. By analyzing a population of patients receiving routine care to confirm previous findings of brexipiprazole’s potential benefit, we are working to close the gap between the clinical study setting and the clinical care setting.”

To read the full manuscript, visit the journal online.

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