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Milsaperidone

Phase 3

Major Depressive Disorder (MDD) | Small molecule | Psychiatry |Vanda Pharmaceuticals Inc.|Last Updated: Feb 27, 2026

Success Probability
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Market & Valuation
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment500
FDA Designations
No designations recorded
Clinical trial landscape

Milsaperidone · 1 trial · 1 indication

Phase 3 1
NCT06830044Evaluation of Efficacy and Safety of Milsaperidone as Adjunctive Therapy in Patients With Major Depressive DisorderMajor Depressive Disorder (MDD)
RECRUITING500 Analytics
PHASE3RECRUITING
Evaluation of Efficacy and Safety of Milsaperidone as Adjunctive Therapy in Patients With Major Depressive Disorder
Major Depressive Disorder (MDD)Unlock trial analytics
Study Endpoints
Primary Endpoints
Change from Baseline in Montgomery-Asberg Depression Rating Scale (MADRS)
6 weeks

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.

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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
MilsaperidoneEXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR -
Interventions
NameTypeDescription
MilsaperidoneDRUGOral milsaperidone
PlaceboDRUGOral placebo
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Eligibility Criteria
Age Range18 Years to 65 Years
SexALL
Healthy VolunteersNo
Study Sites38

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:...

Countries:United StatesBulgariaCzechiaPoland
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT06830044primaryCompletionDate: changed
LOWMay 24, 2026NCT06830044studyFirstPostDate: changed