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Milsaperidone · 1 trial · 1 indication
The MADRS is a clinician-rated 10 item scale. Individual item scores are summed for a total possible score of 0 to 60 with a higher score indicating increased severity of depressive symptoms.
| Arm | Type | Description |
|---|---|---|
| Milsaperidone | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Milsaperidone | DRUG | Oral milsaperidone |
| Placebo | DRUG | Oral placebo |
Inclusion Criteria: * Male or female patient 18 to 65 years of age, inclusive; * Meets DSM-5-TR criteria for MDD * Currently having an inadequate response to antidepressant therapy as confirmed by the Investigator using the Antidepressant Treatment Response Questionnaire (ATRQ) Exclusion Criteria:...
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Milsaperidone is an investigational small molecule being developed as an adjunctive therapy for patients with Major Depressive Disorder (MDD). It is intended to be added to existing treatment to help manage symptoms of depression. The drug is currently in Phase 3 clinical development and has not been approved by regulatory authorities.
Milsaperidone is being developed by Vanda Pharmaceuticals Inc., a biopharmaceutical company traded on NASDAQ under the ticker symbol VNDA. The company is conducting a Phase 3 clinical trial to evaluate the efficacy and safety of Milsaperidone as an adjunctive treatment for Major Depressive Disorder.
Milsaperidone is currently in Phase 3 clinical development. It is an investigational drug, meaning it has not yet been approved by the FDA or other regulatory agencies. The ongoing Phase 3 trial is recruiting participants to assess the drug's efficacy and safety as an adjunctive therapy for Major Depressive Disorder.
Milsaperidone is being studied in a Phase 3 clinical trial with the identifier NCT06830044. This randomized, double-blind, placebo-controlled study is evaluating the efficacy and safety of Milsaperidone as adjunctive therapy in patients with Major Depressive Disorder. The trial aims to enroll 500 participants across the United States, Bulgaria, Czechia, and Poland.
Milsaperidone is not FDA approved. It is an investigational drug currently in Phase 3 clinical development for Major Depressive Disorder. The ongoing clinical trial is designed to evaluate its efficacy and safety, but regulatory approval has not been granted. The drug remains under investigation and is not yet available for clinical use.