Tokyo, Aug. 15 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062536) titled 'Observational Study of Zuranolone in Patients with Mild Major Depressive Disorder' on Aug. 10.
Study Type:
Observational
Primary Sponsor:
Institute - Cosmos Street Psychosomatic Clinic
Condition:
Condition - Mild Depression and Depressive Symptoms
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To collect information on changes regarding depressive symptoms, work productivity, patient global impression of improvement, the symptom that patients consider most concerning, and safety outcomes following the initiation of zuranolone treatment in routine clinical practice among patients with mild depression and depressive symptoms.
Basic objectives2 - Others
Eligibility:
Age-lower limit - 18
years-old
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 written voluntary consent to participate in this study.
2) Male or female patients aged 18 to under 65 at the time of consent acquisition.
3) Patients diagnosed with depression or a depressive symptoms at the study siteat the time of consent acquisition.
4) Patients who are newly starting zuranolone medication, as determined by the principal investigator (or co-investigator) to be appropriate.
5) Patients with a QIDS-J (Quick Inventory of Depressive Symptomatology, Japanese version) total score of 6 to 10 at the first day taking zuranolone.
6) Outpatients.
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.
2) Patients who, on the first day taking Zuranolone, are unable to select one category from the nine categories of the QIDS-J that they perceive as their "most concerning symptom at present."
3) Patients who have been previously administered zuranolone .
4) Patients who have been administered antidepressant treatments within four weeks prior to starting zuranolone.
5) Patients with a history of suicidal ideation, suicide attempts, self-injury, or drug overdose.
Target Size - 50
Recruitment Status:
Recruitment status - Preinitiation
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 14 Day
Last follow-up date - 2027 Year 11 Month 30 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071542
Disclaimer: Curated by HT Syndication.
