When added to an antidepressant,
REXULTI® (brexpiprazole) 2 mg/day was superior in reducing mean MÅDRS total score vs antidepressant + placebo
Mean Change from Baseline in MÅDRS Total Score by Study Visit (Week) in
Patients with MDD in Adults (Study 1)1
Mean Change from Baseline in MÅDRS Total Score by Study Visit (Week) in Patients with MDD in Adults (Study 1)1
It is unknown if the differences observed at time points earlier than Week 6 represent clinically relevant treatment effects.
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.
*p<0.001
Mean MÅDRS before prospective treatment (SD): 31.0 (4.7). Mean MÅDRS after prospective treatment (SD): 27.1 (5.7). Mean MÅDRS at randomization (SD): ADT + placebo (n=178), 27.3 (5.6); ADT + REXULTI 2 mg/day (n=175), 26.9 (5.7).1
MDD study design and efficacy summary
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.3,4
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).
Primary endpoint was the mean change from baseline to Week 6 in the MÅDRS total score in the randomization phase.3,4
In the second pivotal trial, at the 3 mg/day maximum dose, the mean change from baseline (SE) at 6 weeks (randomized phase) was -8.3 (0.5) for ADT + REXULTI (n=213) vs -6.3 (0.5) for ADT + placebo (n=203), and the MÅDRS baseline (SD) for ADT + REXULTI and ADT + placebo was 26.5 (5.3) and 26.5 (5.2), respectively.4
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.4
Full study design
REXULTI® (brexpiprazole)—full MDD study design
Screening—patients with partial response to antidepressant treatment entered the clinical trial with1,4:
- Partial response to 1 to 3 courses of antidepressant treatment in current episode
- MDD ≥8 weeks’ duration
- HAM-D17 score ≥18
- <50% reduction in symptoms via ATRQ
Study 1 (N=1227), Study 2 (N=2310)
Prospective phase—clinical investigators initiated a different antidepressant treatment (+ single-blind placebo) at optimal dose and duration to confirm persistent partial response1,4,a
SSRIs
Escitalopram
Sertraline
Paroxetine CR
Fluoxetine
10 or 20 mg/day
100, 150, or 200 mg/day
37.5 or 50 mg/day
20 or 40 mg/day
SNRIs
Duloxetine DR
Venlafaxine XR
40 or 60 mg/day
75, 150, or 225 mg/day
Study 1 (N=826), Study 2 (N=1532)1,4
Randomized double-blind phase—patients with confirmed partial response were randomized to add REXULTI or remain on antidepressant treatment alone (+ placebo)1,4
ADT + REXULTI
2 mg/day (n=175)c
ADT + Placebo
(n=178)c
ADT + REXULTI
3 mg/day (n=213)c
ADT + Placebo
(n=203)c
Study 1 (N=826), Study 2 (N=1532)1,4
- 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 MÅDRS in the randomization phase3,4
MÅDRS
clinician-rated
symptoms5:
- Apparent sadness
- Reported sadness
- Lassitude
- Inability to feel
- Inner tension
- Inner tension
- Reduced appetite
- Reduced sleep
- Concentration difficulties
- Pessimistic thoughts
- Suicidal thoughts
- Pessimistic thoughts
- Suicidal thoughts
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 MÅDRS Total Score and Clinical Global Impression-Improvement Score of ≥3 at each scheduled visit of the prospective phase.3,4
bThe efficacy and safety of REXULTI 1 mg/day were also studied in Study 2 (n=211).
cn values represent efficacy population per final protocol.3,4
ATRQ, Antidepressant Treatment Response Questionnaire; CR, controlled release; DR, delayed release; HAM-D17, 17-Item Hamilton Depression Rating Scale; MÅDRS, Montgomery-Åsberg Depression Rating Scale; SNRI, serotonin and norepinephrine reuptake inhibitor; SSRI, selective serotonin reuptake inhibitor; XR, extended release.
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; MÅDRS, 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.
Contraindication
In patients with known hypersensitivity to brexpiprazole or any of its components. Reactions have included: rash, facial swelling, urticaria, and anaphylaxis.
Continue exploring REXULTI
