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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
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.
Details
| Lead sponsor | Sunshine Lake Pharma Co., Ltd. |
|---|---|
| Phase | Phase 2/Phase 3 |
| Status | RECRUITING |
| Enrolment | 600 |
| Start date | 2021-12-14 |
| Completion | 2027-11 |
Conditions
- Depressive Disorder, Major
Interventions
- Mitizodone Phosphate tablets
- Placebo-matching tablets
Primary outcomes
- Change From Baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score at week 8 — baseline and week 8
The MADRS is a depression rating scale consisting of 10 items, each rated 0 (normal) to 6 (most abnormal). The 10 items represent the core symptoms of depressive illness. The overall score ranges from 0 (symptoms absent) to 60 (severe depression). A decrease in the total score or on individual items indicates improvement.
Countries
China