Tokyo, Aug. 15 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062537) titled 'A Retrospective Observational Study to Evaluate Real-World Use of Zuranolone in Patients with Major Depressive Disorder' on Aug. 10.

Study Type: Observational

Primary Sponsor: Institute - Cosmos Street Psychosomatic Clinic

Condition: Condition - Depression and Depressive Symptoms Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - To descriptively evaluate the course of depressive symptoms following initiation of Zuranolone treatment in routine clinical practice among patients with depression and depressive symptoms, using the total score of the Quick Inventory of Depressive Symptomatology (QIDS-J, Japanese version) as the assessment measure. Basic objectives2 - Safety

Eligibility: Age-lower limit - 18 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - Patients who meet all of the following criteria will be eligible for inclusion in this study: 1) Patients who have provided voluntary consent for participation in the study including the use of their data for research purposes. 2) Male or female patients aged 18 years of older at the time of initiation of zuranolone treatment. 3) Patients who were diagnosed with depression or depressive states at the study site and received their first administration of zuranolone between March 2026 and June 2026. 4) Patients for whom the following data are available. .Documentation confirming the diagnosis of depression or depressive states .Documentation confirming the date of initiation of zuranolone treatment. .A QIDS-J assessment at the time of initiation of zuranolone treatment. 5) Patients with a QIDS-J total score of 6 points or higher at the time of initiation of zuranolone treatment. Key exclusion criteria - Patients who meet any of the following criteria will be excluded from this study: 1) Patients who are outside the approved indication for zuranolone or have a contraindication to zuranolone. Target Size - 50

Recruitment Status: Recruitment status - Enrolling by invitation Date of protocol fixation - 2026 Year 07 Month 06 Day Date of IRB - 2026 Year 08 Month 03 Day Anticipated trial start date - 2026 Year 08 Month 18 Day Last follow-up date - 2026 Year 09 Month 30 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071543

Disclaimer: Curated by HT Syndication.