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Clinical Trials in Poland / NCT06830044
Recruiting Phase 3

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

NCT06830044 · tracked via the Priya Life Science Poland tracker
Sponsor
Vanda Pharmaceuticals
Phase
Phase 3
Started
2025-03-03
Last updated
2026-09-24

Condition(s) studied

Major Depressive Disorder (MDD)

Investigational drug(s) / intervention(s)

MilsaperidonePlacebo

Milsaperidone: Oral milsaperidone

Placebo: Oral placebo

Study 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

Eligibility

Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
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: * Within the patients lifetime, has a confirmed DSM-5-TR psychiatric diagnosis other than MDD * Within 6 months of Screening, has a confirmed DSM-5-TR psychiatric diagnosis other than MDD * Within 12 months of Screening, has had any other psychiatric condition (other than MDD) that has been the main focus of treatment

Primary outcome measure(s)

  • 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.

Trial sites (53)

FacilityCityRegionStatus
Vanda Investigational Site Phoenix Arizona Recruiting
Vanda Investigational Site Little Rock Arkansas Recruiting
Vanda Investigational Site Garden Grove California Recruiting
Vanda Investigational Site Orange California Recruiting
Vanda Investigational Site Redlands California Recruiting
Vanda Investigational Site San Jose California Recruiting
Vanda Investigational Site Walnut Creek California Recruiting
Vanda Investigational Site Colorado Springs Colorado Recruiting
Vanda Investigational Site Fort Myers Florida Recruiting
Vanda Investigational Site Miami Florida Active Not Recruiting
Vanda Investigational Site Miami Florida Recruiting
Vanda Investigational Site Tampa Florida Active Not Recruiting
Vanda Investigational Site Snellville Georgia Recruiting
Vanda Investigational Site Chicago Illinois Recruiting
Vanda Investigational Site Carmel Indiana Recruiting
Vanda Investigational Site Boston Massachusetts Recruiting
Vanda Investigational Site Saint Charles Missouri Recruiting
Vanda Investigational Site Las Vegas Nevada Recruiting
Vanda Investigational Site New York New York Recruiting
Vanda Investigational Site New York New York Recruiting
Vanda Investigational Site Staten Island New York Recruiting
Vanda Investigational Site Charlotte North Carolina Recruiting
Vanda Investigational Site Cincinnati Ohio Recruiting
Vanda Investigational Site Media Pennsylvania Active Not Recruiting
Vanda Investigational Site Houston Texas Recruiting
Vanda Investigational Site Plano Texas Recruiting
Vanda Investigational Site Richardson Texas Recruiting
Vanda Investigational Site Witchita Falls Texas Recruiting
Vanda Investigational Site Bellevue Washington Recruiting
Vanda Investigational Site Kardzhali Bulgaria Recruiting
Vanda Investigational Site Pleven Bulgaria Recruiting
Vanda Investigational Site Plovdiv Bulgaria Recruiting
Vanda Investigational Site Sofia Bulgaria Recruiting
Vanda Investigational Site Sofia Bulgaria Recruiting
Vanda Investigational Site Sofia Bulgaria Recruiting
Vanda Investigational Site Targovishte Bulgaria Recruiting
Vanda Investigational Site Varna Bulgaria Recruiting
Vanda Investigational Site Vratsa Bulgaria Recruiting
Vanda Investigational Site Brno Czechia Recruiting
Vanda Investigational Site Pilsen Czechia Recruiting

+ 13 more sites — see the full list on the official registry below.

More Vanda Pharmaceuticals trials in Poland

Tolerability Study of Trichostatin A In Subjects With Relapsed or Refractory Hematologic Malignancies Recruiting
Evaluating the Effects of Tasimelteon vs. Placebo in Treating Pediatric Insomnia Recruiting

Other trials for the same condition

A Study to Evaluate the Effectiveness of DT-101 in Patients With Depression Recruiting
An Open-Label Extension Study to Evaluate the Safety and Tolerability of SPT-300 (GlyphAllo) in Participants With Major Depressive Disorder, With or Without Anxious Distress (BUOY-1 OLE Study) Enrolling by invitation
A Study of a Deuterated Psilocin Analog (CYB003) in Humans With Major Depressive Disorder Recruiting
A Study to Evaluate the Efficacy and Safety of SPT-300 (GlyphAllo) in Participants With Major Depressive Disorder, With or Without Anxious Distress (BUOY-1 Study) Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06830044 on ClinicalTrials.gov ↗ ← All trials in Poland