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

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-520333-68-00

Acronym

VP-VHX-896-3201

Enrollment

300

Registered

2025-06-10

Start date

2025-09-26

Completion date

Unknown

Last updated

2025-09-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Major Depressive Disorder

Brief summary

Change from Baseline in Montgomery-Asberg Depression Rating Scale (MADRS)

Interventions

DRUGPlacebo will be provided in size and appearance identical to those containing milsaperidone and will be administered orally.

DRUGMilsaperidone

Eligibility

Sex/Gender

All

Age

18 Years to 64 Years

Design outcomes

Primary

Measure	Time frame
Change from Baseline in Montgomery-Asberg Depression Rating Scale (MADRS)	—

Countries

Bulgaria, Czechia, Poland

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026