Effects of adjunctive brexpiprazole on patient life engagement in major depressive disorder: Post hoc analysis of Inventory of Depressive Symptomatology Self-Report data

Roger S McIntyre; François Therrien; Zahinoor Ismail; Stine R Meehan; Maia Miguelez; Klaus Groes Larsen; Dalei Chen; Erin M MacKenzie; Michael E Thase

doi:10.1016/j.jpsychires.2023.04.012

Effects of adjunctive brexpiprazole on patient life engagement in major depressive disorder: Post hoc analysis of Inventory of Depressive Symptomatology Self-Report data

J Psychiatr Res. 2023 Jun:162:71-78. doi: 10.1016/j.jpsychires.2023.04.012. Epub 2023 Apr 12.

Authors

Roger S McIntyre¹, François Therrien², Zahinoor Ismail³, Stine R Meehan⁴, Maia Miguelez⁵, Klaus Groes Larsen⁴, Dalei Chen⁵, Erin M MacKenzie⁶, Michael E Thase⁷

Affiliations

¹ Mood Disorders Psychopharmacology Unit, University Health Network, University of Toronto, Toronto, ON, Canada. Electronic address: roger.mcintyre@bcdf.org.
² Otsuka Canada Pharmaceutical Inc., Saint-Laurent, Quebec, Canada.
³ Departments of Psychiatry, Clinical Neurosciences, and Community Health Sciences, Hotchkiss Brain Institute and O'Brien Institute for Public Health, University of Calgary, Calgary, AB, Canada.
⁴ H. Lundbeck A/S, Valby, Copenhagen, Denmark.
⁵ Otsuka Pharmaceutical Development & Commercialization Inc., Princeton, NJ, USA.
⁶ Lundbeck Canada Inc., Saint-Laurent, Quebec, Canada.
⁷ Perelman School of Medicine, University of Pennsylvania and the Philadelphia Veterans Affairs Medical Center, Philadelphia, PA, USA.

PMID: 37099968
DOI: 10.1016/j.jpsychires.2023.04.012

Abstract

Background: Patient-reported outcomes can capture domains that are meaningful to patients, such as life engagement in major depressive disorder (MDD), which reflects life fulfillment, well-being, and participation in valued and meaningful activities. This analysis investigated the effects of brexpiprazole adjunct to antidepressant treatment (ADT) on patient life engagement over the short and long term, using the 10-item Inventory of Depressive Symptomatology Self-Report (IDS-SR₁₀) Life Engagement subscale.

Methods: Short-term data were pooled from three 6-week, randomized, double-blind studies of ADT + brexpiprazole 2-3 mg/day versus ADT + placebo in adult outpatients with MDD (DSM-IV-TR criteria) and inadequate response to ADTs. Long-term data were from a 26-52-week, open-label extension study of ADT + brexpiprazole 0.5-3 mg/day.

Results: Over 6 weeks, ADT + brexpiprazole (n = 579) showed greater improvement in IDS-SR₁₀ Life Engagement subscale score than ADT + placebo (n = 583), with a least squares mean difference of -1.19 (95% confidence limits: -1.78, -0.59; p = 0.0001; Cohen's d effect size: 0.23). Greater improvement for ADT + brexpiprazole versus ADT + placebo (p < 0.05) was also observed on eight life engagement items, with effect sizes ranging from 0.12 to 0.24. In the long-term study, mean (standard deviation) IDS-SR₁₀ Life Engagement subscale score changed by -2.4 (4.9) points to Week 26 (n = 2047), and -3.7 (5.3) points to Week 52 (n = 768), with mean improvements on all ten items.

Conclusions: Beyond its efficacy on depressive symptoms, adjunctive brexpiprazole may improve patient life engagement, thereby helping patients with MDD to achieve personally meaningful functional outcomes.

Trial registration: ClinicalTrials.gov NCT01360645 NCT01360632 NCT02196506.

Keywords: Antidepressant; Major depressive disorder; Patient life engagement; Patient-reported outcomes.

Publication types

Randomized Controlled Trial
Research Support, Non-U.S. Gov't

MeSH terms

Adult
Antidepressive Agents / pharmacology
Depressive Disorder, Major* / drug therapy
Double-Blind Method
Drug Therapy, Combination
Humans
Self Report
Treatment Outcome

Substances

brexpiprazole
Antidepressive Agents

Associated data

ClinicalTrials.gov/NCT01360645
ClinicalTrials.gov/NCT01360632
ClinicalTrials.gov/NCT02196506