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Evaluation of Efficacy and Safety of Milsaperidone as Adjunctive Therapy in Patients With Major Depressive Disorder

StatusRecruiting
PhasePhase 3
Started2025-03-03
View on ClinicalTrials.gov ↗

Amendment history

2026-09-25
Trial sites expanded: 38 → 53 locations
2026-02-25
Study Status, Contacts/Locations v3
Study sites20→38
2025-11-10
Study Status, Oversight, Eligibility, Contacts/Locations v2
Study sites2→20
Eligibility criteria-28 characters
[...] as a confirmed DSM-5-TR psychiatric diagnosis other than MDD that is a primary diagnosis Within 12 months of Screening, has had any other psychiatri [...]
2025-05-20
Not Yet Recruiting→Recruiting Study Identification, Study Status, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2025-02→confirmed 2025-03-03
Study sites0→2
Study titlerevised
Evaluation of Efficacy and Safety of Milsaperidone Asas Adjunctive Therapy in Patients withWith Major Depressive Disorder
2025-02-11
Original filing
The purpose of this study is to determine the efficacy and safety of milsaperidone compared to placebo as adjunctive therapy in patients with Major Depressive Disorder
Trial Details
NCT Number NCT06830044
Lead Sponsor Vanda Pharmaceuticals
Conditions Major Depressive Disorder (MDD)
Enrollment 500 participants
Start Date 2025-03-03
Primary Completion 2028-03 (estimated)
Study Completion 2028-03 (estimated)
Updated on ClinicalTrials.gov 2026-09-24