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
- Major Depressive Disorder (MDD)
At a glance
- Phase
- Phase 3
- Study type
- Interventional
- Sponsor
- Vanda Pharmaceuticals
- Enrolment target
- 500
- Started
- 3 March 2025
- Main results due
- March 2028
- Study sites
- 53
- Registry updated
- 24 September 2026
Can you take part?
- Ages 18 years to 65 years.
- Open to any sex.
- You need the condition being studied — healthy volunteers are not accepted.
These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.
Read the full eligibility criteria
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
What this study is about
In the sponsor’s own words, from the registry.
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
Study sites(53)
Vanda Investigational Site
Phoenix, Arizona, United States
Recruiting
Vanda Investigational Site
Little Rock, Arkansas, United States
Recruiting
Vanda Investigational Site
Garden Grove, California, United States
Recruiting
Vanda Investigational Site
Orange, California, United States
Recruiting
Vanda Investigational Site
Redlands, California, United States
Recruiting
Vanda Investigational Site
San Jose, California, United States
Recruiting
Vanda Investigational Site
Walnut Creek, California, United States
Recruiting
Vanda Investigational Site
Colorado Springs, Colorado, United States
Recruiting
Vanda Investigational Site
Fort Myers, Florida, United States
Recruiting
Vanda Investigational Site
Miami, Florida, United States
Active, not recruiting
Vanda Investigational Site
Miami, Florida, United States
Recruiting
Vanda Investigational Site
Tampa, Florida, United States
Active, not recruiting
Vanda Investigational Site
Snellville, Georgia, United States
Recruiting
Vanda Investigational Site
Chicago, Illinois, United States
Recruiting
Vanda Investigational Site
Carmel, Indiana, United States
Recruiting
Vanda Investigational Site
Boston, Massachusetts, United States
Recruiting
Vanda Investigational Site
Saint Charles, Missouri, United States
Recruiting
Vanda Investigational Site
Las Vegas, Nevada, United States
Recruiting
Vanda Investigational Site
New York, New York, United States
Recruiting
Vanda Investigational Site
New York, New York, United States
Recruiting
Vanda Investigational Site
Staten Island, New York, United States
Recruiting
Vanda Investigational Site
Charlotte, North Carolina, United States
Recruiting
Vanda Investigational Site
Cincinnati, Ohio, United States
Recruiting
Vanda Investigational Site
Media, Pennsylvania, United States
Active, not recruiting
Vanda Investigational Site
Houston, Texas, United States
Recruiting
Vanda Investigational Site
Plano, Texas, United States
Recruiting
Vanda Investigational Site
Richardson, Texas, United States
Recruiting
Vanda Investigational Site
Witchita Falls, Texas, United States
Recruiting
Vanda Investigational Site
Bellevue, Washington, United States
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
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
Prague, Czechia
Recruiting
Vanda Investigational Site
Bialystok, Poland
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
Vanda Investigational Site
Torun, Poland
Recruiting
Showing 53 of 53 sites. 50 of the 53 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.
Source: ClinicalTrials.gov record NCT06830044. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.
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