It is unknown if the differences observed at time points earlier than Week 6 represent clinically relevant treatment effects.¹

text-left

text-heading-sage

font-whitney

weight-regular

size-medium

15px | 19.2px

15px | 19.2px

^aNot all patients had an inadequate response to antidepressant alone in the 8-week prospective phase. Only patients with an inadequate response entered the randomized double-blind treatment phase.
^bP<0.001

text-left

text-body

font-whitney

weight-whitney-default

size-medium

10px | 13px

10px | 13px

What is MADRS?

text-center

text-heading-sage

font-whitney

weight-regular

size-medium

15px | 19.2px

15px | 19.2px

Change in MADRS from Baseline at Week 6 (Primary Endpoint) in Adult Patients for Adjunctive Treatment of MDD (Studies 1 and 2)

text-center

text-heading-sage

font-whitney

weight-regular

size-medium

15px | 19.2px

15px | 19.2px

^aDifference (drug minus placebo) in LS mean change from baseline.
^bDosages statistically significantly superior to placebo.
^cThe 1 mg/day dosage was studied in the trial, but is not recommended for the treatment of MDD.
ADT, antidepressant treatment; CI, unadjusted confidence interval; LS, least squares; MADRS, Montgomery-Åsberg Depression Rating Scale; MDD, major depressive disorder; SD, standard deviation; SE, standard error.

text-left

text-body

font-whitney

weight-whitney-default

size-footnote

10px | 13px

10px | 13px

An examination of population subgroups did not suggest differential response based on age, gender, race, or choice of prospective antidepressant.

text-left

text-body

font-whitney

weight-whitney-default

size-caption

14px | 16.8px

14px | 16.8px

MDD study design and efficacy summary

text-left

text-heading-sage

font-whitney

weight-regular

size-medium

17px | 24px

16px | 23px

The efficacy of REXULTI in the adjunctive treatment of major depressive disorder (MDD) was evaluated in two 6-week, double-blind, placebo-controlled, fixed-dose studies of adult patients meeting DSM-IV-TR criteria for MDD, with or without symptoms of anxiety, who had an inadequate response to prior antidepressant therapy (1 to 3 courses) in the current episode. After a screening phase of 1-4 weeks, patients entered into an
8-week prospective treatment phase with an SSRI or SNRI (+ single-blind placebo). Subsequently, patients having persistent symptoms without substantial improvement throughout the course of treatment and who met inclusion criteria were randomized to receive adjunctive REXULTI or placebo.^5,6

In Study 2 for the REXULTI (3 mg/day) + ADT treatment group, the placebo-subtracted difference was -2.0 with a 95% CI (-3.4, -0.5).

text-body

font-whitney

weight-whitney-default

size-medium

15px | 19.2px

15px | 19.2px

Primary endpoint was the mean change from baseline to Week 6 in the MADRS total score in the randomization phase.^5,6

text-body

font-whitney

weight-regular

size-medium

15px | 19.2px

16px | 19.2px

The efficacy and safety of REXULTI were also studied in patients randomized to receive 1 mg/day in Study 2 (n=211). Results for the ADT + REXULTI 1 mg group for the primary efficacy parameter were not statistically significant when compared with ADT + placebo.⁶

text-body

font-whitney

weight-whitney-default

size-medium

12px | 15px

12px | 16.8px

• Titration—all patients randomized to REXULTI initiated treatment at 0.5 mg/day during Week 1. At Week 2, the REXULTI dose was increased to 1 mg/day and either maintained at 1 mg/day or increased to 2 mg/day or 3 mg/day, based on treatment assignment, from Week 3 onward
• Primary endpoint—change from baseline to Week 6 in MADRS in the randomization phase^5,6

text-body-2

font-whitney

weight-whitney-medium

size-large

| 20px

| 18px

870px

bullet-marigold-triangle

^aInclusion criteria for the randomized phase: <50% reduction in HAM-D17 Total Score and ≥14 HAM-D17 score at Week 8 of the prospective phase; <50% reduction in MADRS Total Score and Clinical Global Impression-Improvement Score of ≥3 at each scheduled visit of the prospective phase.^5,6

text-body-2

font-whitney

weight-whitney-light

size-caption

| 16px

14px | 16px

870px

bullet-marigold-triangle

^bThe efficacy and safety of REXULTI 1 mg/day were also studied in Study 2 (n=211).⁶

text-body-2

font-whitney

weight-whitney-light

size-caption

| 16px

14px | 16px

870px

bullet-marigold-triangle

^cn values represent efficacy population per final protocol.^5,6

text-body-2

font-whitney

weight-whitney-light

size-caption

| 16px

14px | 16px

870px

bullet-marigold-triangle

ADT, antidepressant treatment; ATRQ, Antidepressant Treatment Response Questionnaire; CR, controlled release; DR, delayed release; DSM-IV-TR, Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (Text Revision); HAM-D17, 17-Item Hamilton Depression Rating Scale; MADRS, Montgomery-Åsberg Depression Rating Scale; MDD, major depressive disorder; SD, standard deviation; SE, standard error; SNRI, serotonin and norepinephrine reuptake inhibitor; SSRI, selective serotonin reuptake inhibitor; XR, extended release.

text-body

font-whitney

weight-whitney-default

size-medium

12px | 15px

10px | 14px

References: 1. Data on file (REX-284). 2. Appendix 5: validity of outcome measures. Aripiprazole (Abilify): Depression, Major Depressive Disorder (MDD). Canadian Agency for Drugs and Technologies in Health; 2016. NCBI Bookshelf. Accessed June 5, 2024. https://www.ncbi.nlm.nih.gov/books/NBK402734/?report=printable 3. Data on file (REX-104). 4. Montgomery SA, Åsberg M. A new depression scale designed to be sensitive to change. Br J Psychiatry. 1979;134:382-389. 5. Thase ME, Youakim JM, Skuban A, et al. Efficacy and safety of adjunctive brexpiprazole 2 mg in major depressive disorder: a phase 3, randomized, placebo-controlled study in patients with inadequate response to antidepressants. J Clin Psychiatry. 2015;76(9):1224-1231. 6. Thase ME, Youakim JM, Skuban A, et al. Adjunctive brexpiprazole 1 and 3 mg for patients with major depressive disorder following inadequate response to antidepressants: a phase 3, randomized, double-blind study. J Clin Psychiatry. 2015;76(9):1232-1240.

text-body

font-whitney

weight-whitney-default

size-footnote

| 16.8px

11px | 15.4px

939px

container-left

hide-on-mobile reference-text