The Efficacy And Safety Of Mitizodone Phosphate Tablets In The Treatment of Patient With Major Depressive Disorder

This is a phase 2 and 3 adaptive design study for Mitizodone Phosphate,to find out an optimal dose in phase 2 period and confirm the result an efficacy and safety in phase 3 period.Dose-finding will be done after 8 weeks of double-blinded treatment in phase 2 period and will be assessed by both efficacy and safety from 3 dose groups of Mitizodone Phosphate.The dose be found in phase 2 period will be evaluated on efficacy and safety when compared with placebo in phase 3 period with a duration of 8 weeks treatment.The target subjects are patients with MDD.

NCT Number	NCT04984512
Lead Sponsor	Sunshine Lake Pharma Co., Ltd.
Conditions	Depressive Disorder, Major
Enrollment	600 participants
Start Date	2021-12-14
Primary Completion	2027-07 (estimated)
Study Completion	2027-11 (estimated)
Updated on ClinicalTrials.gov	2026-05-05