From the FDA Drug Label
The efficacy of brexpiprazole 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 and who had also demonstrated an inadequate response throughout the 8 weeks of prospective antidepressant treatment (with escitalopram, fluoxetine, paroxetine controlled-release, sertraline, duloxetine delayed-release, or venlafaxine extended-release)
Brexpiprazole can be used as an adjunct to antidepressant therapy (ADT) for treating depression.
- Examples of antidepressants used in the studies include:
- escitalopram
- fluoxetine
- paroxetine controlled-release
- sertraline
- duloxetine delayed-release
- venlafaxine extended-release 1
From the Research
Adjunctive Treatment Options for Brexpiprazole (Rexulti) in Treating Depression
- Brexpiprazole is a serotonin-dopamine activity modulator that has been approved by the US FDA for adjunctive therapy with antidepressant treatment (ADT) in patients with major depressive disorder (MDD) 2.
- Studies have shown that adjunctive brexpiprazole is effective in improving depressive symptoms in adults with MDD who have demonstrated an incomplete response to previous treatment with ADT 2, 3, 4.
- Brexpiprazole has been found to be generally well tolerated in clinical trials, with a lower potential for activation-like adverse effects, such as akathisia, compared to other medications 2, 5.
Efficacy in Patients with Anxious Distress
- Adjunctive brexpiprazole has been shown to be efficacious in reducing depressive symptoms in patients with MDD and anxious distress 3, 4.
- Brexpiprazole has been found to improve symptoms of anxious distress, including tension, restlessness, concentration, and apprehension, in patients with MDD 3.
- The medication has also been shown to improve functioning in patients with MDD and anxious distress, as measured by the Sheehan Disability Scale 4.
Potential Benefits and Future Research
- Brexpiprazole may be a viable option for treating patients with MDD who have inadequate response to ADTs, particularly those with anxious distress 3, 4, 5.
- Further research is needed to determine the long-term efficacy of brexpiprazole and to establish its place in therapy compared to other treatments 5.
- Ongoing and future trials, such as the study examining the effects of adjunctive brexpiprazole on sleep-wake and circadian parameters in youth with depressive disorders, may provide additional insights into the benefits and potential uses of brexpiprazole 6.