Effects of adjunctive brexpiprazole on calmness and life engagement in major depressive disorder: post hoc analysis of patient-reported outcomes from clinical trial exit interviews

Catherine Weiss, Stine R Meehan, T Michelle Brown, Catherine Gupta, Michael F Mørup, Michael E Thase, Roger S McIntyre, Zahinoor Ismail, Catherine Weiss, Stine R Meehan, T Michelle Brown, Catherine Gupta, Michael F Mørup, Michael E Thase, Roger S McIntyre, Zahinoor Ismail

Abstract

Background: Though 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.

Methods: This 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.

Results: 79.8% (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.

Conclusions: Analysis 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.

Keywords: Adjunctive; Antidepressant; Brexpiprazole; Calmness; Clinical trial; Engagement; Major depressive disorder; Patient-reported outcome.

Conflict of interest statement

CW was a full-time employee of Otsuka Pharmaceutical Development & Commercialization Inc. at the time that this work was conducted. SRM and MFM are full-time employees of H. Lundbeck A/S. TMB and CG declare no conflicts of interest. MET has served as an advisor/consultant for Acadia Inc, Akili Inc, Alkermes Plc, Allergan Inc, Axsome, BioHaven Inc, Clexio Pharma, Gerson Lehrman Group Inc, H. Lundbeck A/S, Jazz Pharmaceuticals, Johnson & Johnson, Merck & Company Inc, Otsuka Pharmaceutical Company Ltd, Pfizer Inc, Sage Pharmaceuticals, Seelos Pharmaceuticals, Sunovion Pharmaceuticals Inc, Takeda Pharmaceutical Company Ltd; he has received grant support from Acadia Inc, Allergan Inc, AssureRx Health, Axsome Therapeutics Inc, BioHaven Inc, Intracellular Inc, Johnson & Johnson, Otsuka Pharmaceutical Company Ltd, Patient-Centered Outcomes Research Institute (PCORI), Takeda Pharmaceutical Company Ltd; and royalties from American Psychiatric Foundation, Guilford Publications, Herald House, Kluwer-Wolters, WW Norton & Company Inc; and his spouse is employed by Peloton Advantage, which does business with most major pharmaceutical companies. RSM has received research grant support from CIHR/GACD/Chinese National Natural Research Foundation; and speaker/consultation fees from Lundbeck, Janssen, Purdue, Pfizer, Otsuka, Takeda, Neurocrine, Sunovion, Bausch Health, Novo Nordisk, Kris, Sanofi, Eisai, Intra-Cellular, NewBridge Pharmaceuticals, and AbbVie. He is a CEO of Braxia Scientific Corp. ZI has received grant support from CIHR, NIH, Brain Canada, Weston Foundation, and Janssen, and has served as a consultant for Janssen, Lundbeck and Otsuka. Additionally, his institution has received funds on his behalf from Acadia, Biogen, Roche, and Sunovion.

© 2021. The Author(s).

Figures

Fig. 1
Fig. 1
A Frequency that specific calmness terms were described as being improved (top ten); and B overlap of references to improved anxiety, irritability, and anger (n = 104). ↑ = more; ↓ = less
Fig. 2
Fig. 2
A Number of life engagement domains that each patient described as being improved; B frequency that specific life engagement domains were described as being improved; and C, D overlap of references to emotional, physical, and social/cognitive engagement domains (n = 105)
Fig. 3
Fig. 3
A Frequency that life engagement domains were described as being improved, and B frequency that specific non-calmness terms were described as being improved (top nine), stratified by whether the patient described improvement in calmness (n = 104). aImproved (less or more, depending on the individual). ↑ = more/improved

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