Abstract
BackgroundThough often overlooked, calming patients and increasing their life engagement are key factors in the treatment of major depressive disorder (MDD). This study aimed to test the hypothesis that adjunctive brexpiprazole increases calmness and life engagement among patients with MDD, based on clinical trial exit interviews.MethodsThis was a pooled analysis of exit interview data from three exploratory, open-label studies of adjunctive brexpiprazole 1–3 mg/day. The studies enrolled 105 outpatients with MDD (DSM-IV-TR criteria), a current depressive episode, and inadequate response to antidepressant treatment during the current episode. Patients were interviewed if they completed the end-of-treatment visit (Week 6 or Week 12, depending on the study). Exit interviews took the form of semi-structured telephone interviews in which patients were asked mostly qualitative questions 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 calmness and life engagement vocabulary, allowing aggregation of the frequency of improvement in various domains.Results79.8% (83/104) of patients described improvements consistent with at least one calmness term, most commonly feeling less anxious (46.2%) or less irritable (44.2%). A four-domain concept of patient life engagement was developed in which 88.6% (93/105) of patients described improvements consistent with at least one domain, specifically, emotional (77.1%), physical (75.2%), social (41.9%), and/or cognitive (36.2%). Of the patients who described improvement in calmness, 96.4% (80/83) also described improvement in life engagement.ConclusionsAnalysis of exit interview data suggests that patients were calmer and more engaged with life following treatment with adjunctive brexpiprazole. Thus, adjunctive brexpiprazole may provide a benefit on subjective patient outcomes in addition to the improvement in depressive symptoms shown by clinical rating scale data.Trial Registration: Data used in this post hoc analysis came from ClinicalTrials.gov identifiers: NCT02012218, NCT02013531, NCT02013609.
Highlights
Though often overlooked, calming patients and increasing their life engagement are key factors in the treatment of major depressive disorder (MDD)
Reasons for not completing an exit interview and/or for being excluded from the analysis were: 6 patients could not be reached despite multiple attempts; 1 patient did not speak English; 1 patient reported during the interview having discontinued brexpiprazole; and 1 interview was conducted outside of the permitted 10-day window
The term ‘life engagement’ was considered appropriate to describe the benefits of adjunctive brexpiprazole that related to life fulfillment, well-being, and valued living [12]
Summary
Though often overlooked, calming patients and increasing their life engagement are key factors in the treatment of major depressive disorder (MDD). Patient ‘life engagement’ is a broad term that describes positive health aspects relating to cognition (including ‘hot’ cognition, i.e., cognition colored by emotion), vitality, motivation and reward, and the ability to feel pleasure. It reflects the functional outcomes of life fulfillment, well-being, and participation in valued and meaningful activities [12]. Calming a patient (without sedation) and increasing their life engagement (without overactivation) are key components of the successful treatment of MDD. Despite their importance to patients, such aspects of depression are rarely studied
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