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

NCT06830044 · tracked via the Priya Life Science USA tracker

Sponsor

Vanda Pharmaceuticals

Phase

Phase 3

Started

2025-03-03

Last updated

2026-02-27

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

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 (38)

Facility	City	Region	Status
Vanda Investigational Site	Phoenix	Arizona	Recruiting
Vanda Investigational Site	Little Rock	Arkansas	Recruiting
Vanda Investigational Site	Garden Grove	California	Recruiting
Vanda Investigational Site	Lemon Grove	California	Recruiting
Vanda Investigational Site	Orange	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	Chicago	Illinois	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	Staten Island	New York	Recruiting
Vanda Investigational Site	Media	Pennsylvania	Recruiting
Vanda Investigational Site	Richardson	Texas	Recruiting
Vanda Investigational Site	Witchita Falls	Texas	Recruiting
Vanda Investigational Site	Bellevue	Washington	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	Brno	Czechia	Recruiting
Vanda Investigational Site	Pilsen	Czechia	Recruiting
Vanda Investigational Site	Poruba	Czechia	Recruiting
Vanda Investigational Site	Prague	Czechia	Recruiting
Vanda Investigational Site	Prague	Czechia	Recruiting
Vanda Investigational Site	Prague	Czechia	Recruiting
Vanda Investigational Site	Bialystok	Poland	Recruiting
Vanda Investigational Site	Bydgoszcz	Poland	Recruiting
Vanda Investigational Site	Gdansk	Poland	Recruiting
Vanda Investigational Site	Katowice	Poland	Recruiting
Vanda Investigational Site	Katowice	Poland	Recruiting
Vanda Investigational Site	Suchy Las	Poland	Recruiting

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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 the USA