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

Tokyo, April 3 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061137) titled 'Efficacy and Safety of Adjunctive Brexpiprazole in Patients With Major Depressive Disorder with Anxious Distress: An Exploratory, Multicenter Study' on April 2.

Study Type: Observational

Primary Sponsor: Institute - Kansai Medical University Medical Center

Condition: Condition - Major depressive disorder Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - To evaluate the efficacy and safety of brexpiprazole augmentation therapy for depressive symptoms in patients with major depressive disorder with anxious distress Basic objectives2 - Safety,Efficacy

Eligibility: Age-lower limit - 18 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key 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 Key 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 Target Size - 100

Recruitment Status: Recruitment status - Open public recruiting Date of protocol fixation - 2025 Year 12 Month 03 Day Date of IRB - 2025 Year 12 Month 03 Day Anticipated trial start date - 2026 Year 02 Month 01 Day Last follow-up date - 2026 Year 12 Month 14 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069958

Disclaimer: Curated by HT Syndication.