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Also known as Mitizodone Phosphate tablets
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...
Mitizodone is an investigational small molecule being developed for the treatment of Major Depressive Disorder. It is currently in Phase 2 clinical development and is not yet approved by regulatory authorities. The drug is being studied in patients with this psychiatric condition.
Mitizodone is being developed by Sunshine Biopharma Inc., a company listed on the stock exchange under the ticker symbol SBFM. The company is conducting clinical trials to evaluate the safety and efficacy of this investigational drug for Major Depressive Disorder.
Mitizodone is currently in Phase 2 clinical development. It is an investigational drug, meaning it has not been approved by regulatory agencies. The ongoing Phase 2 trial is actively recruiting participants to study the drug's effects in patients with Major Depressive Disorder.
Mitizodone is being studied in a Phase 2 clinical trial registered as NCT04984512. This randomized, double-blind, active-controlled study is evaluating the efficacy and safety of Mitizodone Phosphate tablets in patients with Major Depressive Disorder. The trial is recruiting 600 participants in China.
Yes, Mitizodone is also known as Mitizodone Phosphate tablets. The drug is being studied in clinical trials under this alternative name, which refers to the phosphate salt formulation of the active pharmaceutical ingredient.