Evaluation of Efficacy and Safety of Milsaperidone as Adjunctive Therapy in Patients With Major Depressive Disorder
NCT ID: NCT06830044
Last Updated: 2025-11-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
500 participants
INTERVENTIONAL
2025-03-03
2028-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Milsaperidone
Milsaperidone
Oral milsaperidone
Placebo
Placebo
Oral placebo
Interventions
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Milsaperidone
Oral milsaperidone
Placebo
Oral placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
65 Years
ALL
No
Sponsors
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Vanda Pharmaceuticals
INDUSTRY
Responsible Party
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Locations
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Vanda Investigational Site
Little Rock, Arkansas, United States
Vanda Investigational Site
Garden Grove, California, United States
Vanda Investigational Site
Orange, California, United States
Vanda Investigational Site
San Jose, California, United States
Vanda Investigational Site
Colorado Springs, Colorado, United States
Vanda Investigational Site
Fort Myers, Florida, United States
Vanda Investigational Site
Miami, Florida, United States
Vanda Investigational Site
Miami, Florida, United States
Vanda Investigational Site
Tampa, Florida, United States
Vanda Investigational Site
Chicago, Illinois, United States
Vanda Investigational Site
Saint Charles, Missouri, United States
Vanda Investigational Site
Las Vegas, Nevada, United States
Vanda Investigational Site
Staten Island, New York, United States
Vanda Investigational Site
Media, Pennsylvania, United States
Vanda Investigational Site
Richardson, Texas, United States
Vanda Investigational Site
Witchita Falls, Texas, United States
Vanda Investigational Site
Sofia, , Bulgaria
Vanda Investigational Site
Varna, , Bulgaria
Vanda Investigational Site
Brno, , Czechia
Vanda Investigational Site
Prague, , Czechia
Countries
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Central Contacts
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Facility Contacts
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Vanda Pharmaceuticals Inc.
Role: primary
Vanda Pharmaceuticals Inc.
Role: primary
Vanda Pharmaceuticals Inc.
Role: primary
Vanda Pharmaceuticals Inc.
Role: primary
Vanda Pharmaceuticals Inc.
Role: primary
Vanda Pharmaceuticals Inc.
Role: primary
Vanda Pharmaceuticals Inc.
Role: primary
Vanda Pharmaceuticals Inc.
Role: primary
Vanda Pharmaceuticals Inc.
Role: primary
Vanda Pharmaceuticals Inc.
Role: primary
Vanda Pharmaceuticals Inc.
Role: primary
Vanda Pharmaceuticals Inc.
Role: primary
Vanda Pharmaceuticals Inc.
Role: primary
Vanda Pharmaceuticals Inc.
Role: primary
Vanda Pharmaceuticals Inc.
Role: primary
Vanda Pharmaceuticals Inc.
Role: primary
Vanda Pharmaceuticals Inc.
Role: primary
Vanda Pharmaceuticals Inc.
Role: primary
Other Identifiers
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VP-VHX-896-3201
Identifier Type: -
Identifier Source: org_study_id