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

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

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.

Publication types

  • Meta-Analysis
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Antidepressive Agents / administration & dosage*
  • Depressive Disorder, Major / diagnosis*
  • Depressive Disorder, Major / drug therapy*
  • Depressive Disorder, Major / psychology
  • Disability Evaluation*
  • Double-Blind Method
  • Drug Therapy, Combination
  • Humans
  • Prospective Studies
  • Quinolones / administration & dosage*
  • Randomized Controlled Trials as Topic / methods*
  • Serotonin Agents / administration & dosage
  • Single-Blind Method
  • Thiophenes / administration & dosage*

Substances

  • Antidepressive Agents
  • Quinolones
  • Serotonin Agents
  • Thiophenes
  • brexpiprazole

Associated data

  • ClinicalTrials.gov/NCT01360632
  • ClinicalTrials.gov/NCT01727726
  • ClinicalTrials.gov/NCT01052077
  • ClinicalTrials.gov/NCT01360645
  • ClinicalTrials.gov/NCT00797966
  • ClinicalTrials.gov/NCT02196506