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. 2019 Mar 1;22(3):173-179.
doi: 10.1093/ijnp/pyy095.

Adjunctive Brexpiprazole and Functioning in Major Depressive Disorder: A Pooled Analysis of Six Randomized Studies Using the Sheehan Disability Scale

Mary Hobart  1 , Peter Zhang  1 , Catherine Weiss  1 , Stine Rasmussen Meehan  1 , Hans Eriksson  1
Affiliations

Adjunctive Brexpiprazole and Functioning in Major Depressive Disorder: A Pooled Analysis of Six Randomized Studies Using the Sheehan Disability Scale

Mary Hobart et al. Int J Neuropsychopharmacol. .

Abstract

Background: Patients with major depressive disorder and inadequate response to antidepressant treatments may experience a prolonged loss of functioning. This post hoc analysis aimed to determine the effect of adjunctive brexpiprazole on functioning in such patients.

Methods: A pooled analysis of data from the 6-week, randomized, double-blind treatment phases of 6 studies of adjunctive brexpiprazole (2 and 3 mg/d in fixed-dose studies; 1-3 mg/d in flexible-dose studies) vs placebo in patients with major depressive disorder and inadequate response to antidepressant treatments (NCT01360645, NCT01360632, NCT02196506, NCT01727726, NCT00797966, NCT01052077). Functioning was measured by change in Sheehan Disability Scale score from baseline to week 6.

Results: Considering Sheehan Disability Scale mean score across all 6 studies (n = 2066 randomized), the least squares mean difference between antidepressant treatments + brexpiprazole and antidepressant treatments + placebo at week 6 was -0.40 (95% CI: -0.56, -0.23; P < .0001). Antidepressant treatments + brexpiprazole showed a greater benefit than antidepressant treatments + placebo on the social life (-0.45; -0.63, -0.27; P < .001) and family life (-0.50; -0.70, -0.31; P < .001) items but not on the work/studies item (-0.16; -0.38, 0.06; P = .16). Pooled analyses of just the (1) fixed-dose, (2) flexible-dose, and (3) Phase 3 studies showed the same pattern of benefits for antidepressant treatments + brexpiprazole.

Conclusions: Brexpiprazole, as adjunct to antidepressant treatments, improved functioning in patients with major depressive disorder and inadequate response to antidepressant treatments.

Keywords: Sheehan Disability Scale; adjunctive; brexpiprazole; depression; functioning.

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Figures

Figure 1.
Figure 1.
Estimated treatment effect for antidepressant treatment (ADT) + brexpiprazole: mean change in Sheehan Disability Scale (SDS) mean score from baseline to week 6 (efficacy populationa). Abbreviations: CI, confidence interval; LS, least squares; MMRM, mixed model for repeated measures. MMRM for Pyxis, Polaris, Sirius, and Delphinus; ANCOVA for Study 211 and Study 222; MMRM for pooled analyses. aPer target population, defined as patients who met criteria for consistent inadequate response throughout the prospective treatment phase. This definition was retrospectively applied to study 211 and study 222.
Figure 2.
Figure 2.
Mean change in Sheehan Disability Scale (SDS) mean and item scores from baseline to week 6, for all studies pooled (efficacy populationa). Abbreviations: ADT, antidepressant treatment; LS, least squares; MMRM, mixed model for repeated measures. ***P < .001 vs ADT + placebo; MMRM. aPer target population, defined as patients who met criteria for consistent inadequate response throughout the prospective treatment phase. This definition was retrospectively applied to study 211 and study 222. bThe following brexpiprazole dose groups were included in the pooled analysis: Pyxis and Sirius, 2 mg/d; Polaris, 3 mg/d; Delphinus, 2–3 mg/d; study 211, 1.5 ± 0.5 mg/d; study 222, 1–3 mg/d.
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