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Also known as VHX-896
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 studied as an adjunctive therapy for patients with Major Depressive Disorder (MDD). It is intended to be added to existing antidepressant treatment to improve efficacy in patients who have not responded adequately to standard therapy. The drug is currently in Phase 3 clinical development.
Milsaperidone targets the D2 and 5-HT2A receptors. By acting on these receptors, it is designed to modulate dopamine and serotonin pathways, which are implicated in the regulation of mood. This dual receptor activity is being investigated for its potential to enhance antidepressant effects when used as an adjunctive treatment for Major Depressive Disorder.
Milsaperidone is being developed by Vanda Pharmaceuticals Inc., a biopharmaceutical company traded on the Nasdaq under the ticker symbol VNDA. Vanda is conducting the clinical development program for Milsaperidone, which is currently in Phase 3 trials for Major Depressive Disorder.
Milsaperidone is in Phase 3 clinical development. It is an investigational drug, meaning it has not yet been approved by regulatory authorities. The ongoing Phase 3 trial is evaluating its efficacy and safety as an adjunctive therapy in patients with Major Depressive Disorder.
Milsaperidone is being evaluated in a Phase 3 clinical trial registered as NCT06830044. This randomized, double-blind, placebo-controlled study is assessing the efficacy and safety of Milsaperidone as adjunctive therapy in patients with Major Depressive Disorder. The trial is currently recruiting participants and aims to enroll approximately 500 patients.
Milsaperidone is the sole name provided for this investigational compound. It is not known to be marketed under any alternative brand names or aliases. The drug is being developed exclusively by Vanda Pharmaceuticals and is identified by its generic name, Milsaperidone, in clinical and regulatory contexts.