Actively Recruiting

Phase 3
Age: 18Years - 65Years
All Genders
NCT06830044

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

Led by Vanda Pharmaceuticals · Updated on 2026-02-27

500

Participants Needed

38

Research Sites

156 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Male or female patients aged 18 to 65 years, inclusive
  • Diagnosed with Major Depressive Disorder according to DSM-5-TR criteria
  • Currently experiencing inadequate response to antidepressant therapy as confirmed by the Investigator using the Antidepressant Treatment Response Questionnaire (ATRQ)
Not Eligible

You will not qualify if you...

  • Any confirmed DSM-5-TR psychiatric diagnosis other than Major Depressive Disorder during the patient's lifetime
  • Any confirmed DSM-5-TR psychiatric diagnosis other than Major Depressive Disorder within 6 months before screening
  • Any other psychiatric condition (besides Major Depressive Disorder) that has been the main focus of treatment within 12 months before screening

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 38 locations

1

Vanda Investigational Site

Phoenix, Arizona, United States, 85012

Actively Recruiting

2

Vanda Investigational Site

Little Rock, Arkansas, United States, 72211

Actively Recruiting

3

Vanda Investigational Site

Garden Grove, California, United States, 92845

Actively Recruiting

4

Vanda Investigational Site

Lemon Grove, California, United States, 91945

Actively Recruiting

5

Vanda Investigational Site

Orange, California, United States, 92868

Actively Recruiting

6

Vanda Investigational Site

San Jose, California, United States, 95124

Actively Recruiting

7

Vanda Investigational Site

Walnut Creek, California, United States, 94596

Actively Recruiting

8

Vanda Investigational Site

Colorado Springs, Colorado, United States, 80910

Actively Recruiting

9

Vanda Investigational Site

Fort Myers, Florida, United States, 33912

Actively Recruiting

10

Vanda Investigational Site

Miami, Florida, United States, 33135

Active, Not Recruiting

11

Vanda Investigational Site

Miami, Florida, United States, 33173

Actively Recruiting

12

Vanda Investigational Site

Tampa, Florida, United States, 33614

Active, Not Recruiting

13

Vanda Investigational Site

Chicago, Illinois, United States, 60634

Actively Recruiting

14

Vanda Investigational Site

Saint Charles, Missouri, United States, 63304

Actively Recruiting

15

Vanda Investigational Site

Las Vegas, Nevada, United States, 89119

Actively Recruiting

16

Vanda Investigational Site

New York, New York, United States, 10035

Actively Recruiting

17

Vanda Investigational Site

Staten Island, New York, United States, 10314

Actively Recruiting

18

Vanda Investigational Site

Media, Pennsylvania, United States, 19063

Actively Recruiting

19

Vanda Investigational Site

Richardson, Texas, United States, 75080

Actively Recruiting

20

Vanda Investigational Site

Witchita Falls, Texas, United States, 76309

Actively Recruiting

21

Vanda Investigational Site

Bellevue, Washington, United States, 98007

Actively Recruiting

22

Vanda Investigational Site

Sofia, Bulgaria, 1202

Actively Recruiting

23

Vanda Investigational Site

Sofia, Bulgaria, 1618

Actively Recruiting

24

Vanda Investigational Site

Sofia, Bulgaria, 1680

Actively Recruiting

25

Vanda Investigational Site

Targovishte, Bulgaria, 7700

Actively Recruiting

26

Vanda Investigational Site

Varna, Bulgaria, 9020

Actively Recruiting

27

Vanda Investigational Site

Brno, Czechia, 60200

Actively Recruiting

28

Vanda Investigational Site

Pilsen, Czechia, 30100

Actively Recruiting

29

Vanda Investigational Site

Poruba, Czechia, 70800

Actively Recruiting

30

Vanda Investigational Site

Prague, Czechia, 100 00

Actively Recruiting

31

Vanda Investigational Site

Prague, Czechia, 15000

Actively Recruiting

32

Vanda Investigational Site

Prague, Czechia, 16000

Actively Recruiting

33

Vanda Investigational Site

Bialystok, Poland, 15-756

Actively Recruiting

34

Vanda Investigational Site

Bydgoszcz, Poland, 85-794

Actively Recruiting

35

Vanda Investigational Site

Gdansk, Poland, 80-952

Actively Recruiting

36

Vanda Investigational Site

Katowice, Poland, 40-514

Actively Recruiting

37

Vanda Investigational Site

Katowice, Poland, 40-600

Actively Recruiting

38

Vanda Investigational Site

Suchy Las, Poland, 62-002

Actively Recruiting

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Research Team

V

Vanda Pharmaceuticals

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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