Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Mitizodone · 1 trial · 1 indication
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.
| Arm | Type | Description |
|---|---|---|
| Mitizodone Phosphate tablet 10mg | EXPERIMENTAL | Mitizodone Phosphate tablet 10mg ,orally,once daily for 8 weeks, then placebo,orally,once daily for 2 weeks. |
| Mitizodone Phosphate tablet 20mg | EXPERIMENTAL | Mitizodone Phosphate tablet 10mg ,orally,once daily for 1 weeks, then Mitizodone Phosphate tablet 20mg ,orally,once daily for 7 weeks, then Mitizodone Phosphate tablet 10mg ,orally,once daily for 1 weeks, then placebo,orally,once daily for 1 weeks. |
| Mitizodone Phosphate tablet 40mg | EXPERIMENTAL | Mitizodone Phosphate tablet 10mg ,orally,once daily for 1 weeks, then Mitizodone Phosphate tablet 20mg ,orally,once daily for 1 weeks, then Mitizodone Phosphate tablet 40mg ,orally,once daily for 6 weeks, then Mitizodone Phosphate tablet 20mg ,orally,once daily for 1 weeks, then Mitizodone Phosphate tablet 10mg ,orally,once daily for 1 weeks. |
| Placebo | ACTIVE_COMPARATOR | Placebo,tablet,orally,once daily for 10 weeks. |
| Name | Type | Description |
|---|---|---|
| Mitizodone Phosphate tablets | DRUG | Mitizodone Phosphate tablets will be administered with food. |
| Placebo-matching tablets | DRUG | Placebo will be administered with food. |
Inclusion Criteria: * 1.a Man or a woman with major depressive disorder(MDD) as the primary diagnosis according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria (classification code 296.22、296.23、296.32、296.33) * 2.Has a Montgomery Åsberg Depression Ratin...