Major depressive disorder
Conditions
Interventions
None listed
Sponsors
Kansai Medical University Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Outpatients aged 18 years or older at the time of obtaining informed consent 2. Patients diagnosed with major depressive disorder according to DSM-5/DSM-5-TR diagnostic criteria, with the specifier "with anxious distress" 3. Patients who have not achieved sufficient effect despite multiple appropriate treatments with selective serotonin reuptake inhibitors (SSRIs), serotonin-norepinephrine reuptake inhibitors (SNRIs), etc., for the depressive episode at the time of obtaining consent 4. Patients for whom brexpiprazole augmentation therapy with antidepressants is deemed necessary in routine clinical practice, and who have been additionally prescribed brexpiprazole with SSRIs, SNRIs, or mirtazapine 5. Patients who have received sufficient explanation about participation in this study, fully understood it, and provided written consent of their own free will
Exclusion criteria
Exclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Japan
Contacts
Public ContactKato Masaki
Kansai Medical University Medical Center Department of Neuropsychiatry
Outcome results
None listed