NCT06830044

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

A Randomized, Double-Blind, Placebo-controlled Multicenter Study to Assess the Efficacy and Safety of Milsaperidone as Adjunctive Therapy in the Treatment of Patients With Major Depressive Disorder

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 500 (estimated)
• Sponsor: Vanda Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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

Conditions

• Major Depressive Disorder (MDD)

Interventions

Type	Name	Description
DRUG	Milsaperidone	Oral milsaperidone
DRUG	Placebo	Oral placebo

Timeline

• Start date: 2025-03-03
• Primary completion: 2028-03-01
• Completion: 2028-03-01
• First posted: 2025-02-17
• Last updated: 2026-02-27

Locations

38 sites across 4 countries: United States, Bulgaria, Czechia, Poland

Regulatory

• FDA-regulated drug study