Conditions: Major Depression Disorder
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 132
Healthy volunteers: no

Brief summary:
The purpose of this study is to evaluate the safety and tolerability of brexpiprazole as adjunctive treatment in an elderly population with major depressive disorder and an inadequate response to antidepressant treatment

Detailed description:

Arms:
arm 1: All patients continue their current antidepressant treatment (ADT) and receive brexpiprazole in addition

Interventions: intervention 1: Adjunct brexpiprazole intervention 2: ADT
Intervention descriptions: intervention 1: Weeks 1-4 titration from 0.5 up to 2 mg once daily, in weekly steps. For the rest of the 26 treatment weeks, maintenance with 1-3 mg once daily.

Tablets for oral use once daily during 26 weeks. Tablet strengths: 0.5 mg, 1 mg, 2 mg and 3 mg. intervention 2: Citalopram, ecitalopram, fluoxetine, sertraline, paroxetine IR, paroxetine CR, venlafaxine IR, venlafaxine XR (extended release), desvenlafaxine, duloxetine, mirtazapine, agomelatine, bupropion; dosing according to label

Protocol document: