NCT04984512

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

A Phase II/III ,Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled, Adaptive Design Study Evaluating the Efficacy And Safety of Mitizodone Phosphate Tablets in the Treatment of Patient With Major Depressive Disorder

• Status: Unknown
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 600 (estimated)
• Sponsor: Sunshine Lake Pharma Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Depressive Disorder, Major

Interventions

Type	Name	Description
DRUG	Mitizodone Phosphate tablets	Mitizodone Phosphate tablets will be administered with food.
DRUG	Placebo-matching tablets	Placebo will be administered with food.

Timeline

• Start date: 2021-11-01
• Primary completion: 2024-04-01
• Completion: 2024-05-01
• First posted: 2021-07-30
• Last updated: 2021-10-15