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
Open accessAbstract
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.
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The life engagement framework is split into four domains: emotional (affect/mood), physical (energy), social (interest), and cognitive (alertness/thinking).
“Specifically, in the new framework, life engagement is split into four domains: emotional (affect/mood), physical (energy), social (interest), and cognitive (alertness/thinking).”
From Patient-reported outcome measures for life engagement in mental health: a systematic review (2022) · cites this paper as [9]
Life engagement incorporates improvement of anhedonia and apathy, but anhedonia and apathy alone do not describe the aspects of life engagement relating to attention, alertness, and clarity of thought.
“For example, life engagement incorporates improvement of anhedonia (which comprises motivational and consummatory aspects [13]) and apathy (which comprises behavior/cognition, emotion, and social interaction dimensions [14])—important treatment targets in mental health [15, 16]. However, anhedonia and apathy alone do not describe the aspects of life engagement relating to attention, alertness, and”
From Patient-reported outcome measures for life engagement in mental health: a systematic review (2022) · cites this paper as [9]
Life engagement in mental health includes positive health aspects relating to cognition (including hot cognition), vitality, motivation and reward, and the ability to feel pleasure.
“The life engagement concept includes 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, and was developed based on transcripts from patient interviews and discussion with a panel of expert psychiatrists [9].”
From Patient-reported outcome measures for life engagement in mental health: a systematic review (2022) · cites this paper as [9]
There are no validated PROs that can capture all aspects of life engagement within the conceptual framework defined by expert psychiatrists.
“Overall, the results of this review indicate that there are no validated PROs that can capture all aspects of life engagement within the conceptual framework defined by expert psychiatrists [9]”
From Patient-reported outcome measures for life engagement in mental health: a systematic review (2022) · cites this paper as [9]
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Patient-reported outcome measures for life engagement in mental health: a systematic review
McIntyre, R. S., Ismail, Z., Watling, C. P., Weiss, C., Meehan, S. R., Musingarimi, P., & Thase, M. E. (2022) · Journal of Patient-Reported Outcomes · doi:10.1186/s41687-022-00468-5 · Cited by 48 · see citing works
Self-citation
- Authors
- Weiss, C., Meehan, S. R., Brown, T. M., Gupta, C., Mørup, M. F., Thase, M. E., McIntyre, R. S., & Ismail, Z.
- Affiliations
- Otsuka (United States) (US)
- Lundbeck (Denmark) (DK)
- RTI Health Solutions (US)
- Philadelphia VA Medical Center (US)
- University Health Network (CA)
- University of Calgary (CA)
- Corresponding author
- Weiss, Catherine
- ORCID
- Venue
- Journal of Patient-Reported Outcomes
- Published
- 2021-12
- Volume
- 5
- Issue
- 1
- Pages
- 128-128
- ISSN
- 2509-8020 (ISSN-L)
- PMC
- PMC8665966
- OpenAlex
- W4200621182
- Cited by
- 25
- References
- 39
- Citations by year
- 2026: 6 · 2025: 7 · 2024: 3 · 2023: 4 · 2022: 5
- FWCI
- 1.75
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Licence
- Locations
- Journal of Patient-Reported Outcomes (publishedVersion, cc-by)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- TSpace (University of Toronto) (submittedVersion)
- DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion, cc-by-sa)
- Libraries and Cultural Resources (University of Calgary) (submittedVersion)
- Funders
- H. Lundbeck A/S
- Otsuka Pharmaceutical Development and Commercialization Inc.
- Topics
- Health Sciences › Medicine › Pharmacology › Treatment of Major Depression
- Health Sciences › Medicine › Psychiatry and Mental health › Schizophrenia research and treatment
- Social Sciences › Psychology › Clinical Psychology › Psychotherapy Techniques and Applications
- Keywords
- brexpiprazole, major depressive disorder, adjunctive therapy, tranquility, life engagement, patient-reported outcomes, exit interviews, anxiety reduction, irritability, subjective well-being, atypical antipsychotics
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