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Efficacy and Safety of Adjunctive Brexpiprazole in Patients With Major Depressive Disorder with Anxious Distress: An Exploratory, Multicenter Study

Basic Information

Recruitment status	Recruiting
Health condition(s) or Problem(s) studied	Major depressive disorder
Date of first enrollment	2026/02/01
Target sample size	100
Countries of recruitment	Japan
Study type	Observational
Intervention(s)

Outcome(s)

Primary Outcome	Mean change in MADRS total score from baseline to week 6 after initiation of brexpiprazole augmentation therapy in patients with major depressive disorder with anxious distress
Secondary Outcome	The response rate and remission rate on MADRS and improvement rate on CGI-I at Week 6; and changes from baseline to Week 6 in CUDOS-A, CGI-S, and SDS scores.

Key inclusion & exclusion criteria

Age minimum	18years-old
Age maximum	Not applicable
Gender	Male and Female
Include criteria
Exclude criteria	1.Patients who have received antipsychotic medication during the depressive episode period at the time of obtaining consent until the day before obtaining informed consent 2. Other patients deemed inappropriate as research subjects by the principal investigator or sub-investigator