Patient-Reported Effects of Adjunctive Brexpiprazole on Calming and Engagement in Major Depressive Disorder: Post Hoc Analysis of Clinical Trial Exit Interviews

Background: Calming patients (without sedation) and increasing engagement (without overactivation) are important components of the successful treatment of major depressive disorder (MDD). The aim of this analysis was to investigate patient experiences with adjunctive brexpiprazole in MDD, in the context of feeling calm and engaged with life.

Methods: This was a pooled analysis of exit interview data from three 6-12 week, exploratory, open-label studies of oral adjunctive brexpiprazole 1-3 mg/day in outpatients with MDD (DSM-IV-TR criteria) and inadequate response to antidepressant treatments (ClinicalTrials.gov identifiers: NCT02012218, NCT02013531, NCT02013609). In semi-structured telephone interviews, patients were asked about their symptoms prior to the start of the study, and about improvements they had noted during treatment. Interview transcripts were reviewed and codes were assigned to calming and engagement vocabulary, allowing aggregation of the frequency of improvement in various domains.

Results: Of 104 interviewed patients, 79.8% referred to improvements in calming by denoting improvement in at least one calming term, most commonly feeling less anxious (46.2%), less irritable (44.2%), less angry (28.8%), less worried (17.3%), and more calm (17.3%). Of the patients who referred to improvement in calming, 96.4% also referred to improvement in engagement. Specifically, 75.9% said they had more energy, 75.9% said they had more motivation, and 69.9% said they had improved social interactions.

Conclusion: Exit interviews give the patient perspective of treatment and can be used to supplement clinical trial data. Analysis of exit interview data suggests that patients receiving adjunctive brexpiprazole were calmer and more engaged following treatment.