Patient-reported efficacy of adjunctive brexpiprazole in major depressive disorder in a phase 4, open-label, interventional study
Year: 2025
Type: article
Abstract: OBJECTIVES: In ENGAGE, patients with major depressive disorder (MDD) demonstrated improvements in patient-reported depression and life engagement while taking adjunctive brexpiprazole. This analysis aimed to further characterize patient perspectives on the effects of adjunctive brexpiprazole, using patient diary data from ENGAGE, and describe the development of a 'word of the day' activity. METHODS: Prior to ENGAGE, word lists describing a 'good,' 'average,' and 'bad' day with depression were generated from semi-structured interviews with patients with MDD. ENGAGE (ClinicalTrials.gov identifier: NCT04830215) was an 8-week, phase 4, single-arm, open-label study of adjunctive brexpiprazole 0.5-2 mg/day in patients with MDD and inadequate response to antidepressant treatment. Patient diaries were completed periodically at home, comprising the Patient Global Impression - Severity of illness (PGI-S), Patient Global Impression - Improvement (PGI-I), and a 'word of the day' activity in which patients selected one word to describe how they felt that day. This analysis evaluated mean change in PGI-S scores (mixed model for repeated measures), mean PGI-I scores (descriptive statistics), PGI-S response and PGI-S sustained response (Kaplan-Meier), PGI-I response (normal approximation), and 'word of the day' (descriptive statistics). RESULTS: < 0.001; effect size: 1.04). PGI-I scores at week 8 indicated 'minimal improvement' to 'much improvement' (mean [standard deviation]: 2.6 [1.1]). At week 8, rates of PGI-S response, sustained PGI-S response, and PGI-I response were 86.0% (95% confidence interval: 77.1, 92.8), 67.9% (54.5, 80.6), and 47.1% (38.1, 56.0), respectively. On 'word of the day,' the proportion of positive and neutral words increased from baseline to week 8, and the proportion of negative words decreased. CONCLUSIONS: Patient-reported diary data revealed early and sustained improvements in depressive symptom severity during 8 weeks of adjunctive brexpiprazole treatment. 'Word of the day' may be an effective qualitative tool for future trials.
Institutions: Otsuka Canada Pharmaceutical Inc. (Canada), University of Alberta, University of Toronto, University of Calgary, Hotchkiss Brain Institute, O'Brien Institute for Public Health, RTI Health Solutions, Otsuka Pharmaceutical Development & Commercialization, Inc. (United States), Lundbeck Canada (Canada)
Language: English
Subfield: Pharmacology (medical)
Field: Medicine
Domain: Health Sciences
Open Access status: hybrid
OpenAlex ID: W4414036237