New drug milsaperidone aims to boost depression treatment
NCT ID NCT06830044
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This Phase 3 study tests whether adding milsaperidone to standard antidepressant therapy helps adults with major depressive disorder who still have symptoms. About 500 participants will receive either milsaperidone or a placebo, and researchers will measure changes in depression severity using a standard rating scale.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- milsaperidone (also called VHX-896)
- What this could lead to
- If it works, this could provide a new add-on treatment option for people with major depressive disorder who haven't gotten enough relief from standard antidepressants.
- What could go wrong
- This is a Phase 3 trial, but it's still experimental. The drug may not prove more effective than placebo, and side effects are possible. Results may not apply to all patients with depression.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 500 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2025
- Expected to finish
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Mar 2028
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 65 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Major depressive disorder (MDD) are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The study's own enquiry address
This study publishes an address for enquiries. See it below .
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The places running it
36 sites in 4 countries. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Show contact details
Enter your email to view the contact information for this study.
Genom att skicka in godkänner du våra Användarvillkor
Study contacts
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Contact
Email: •••••@•••••
Locations
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Vanda Investigational Site
RECRUITINGPhoenix, Arizona, 85012, United States
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Vanda Investigational Site
RECRUITINGLittle Rock, Arkansas, 72211, United States
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Vanda Investigational Site
RECRUITINGGarden Grove, California, 92845, United States
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Vanda Investigational Site
RECRUITINGLemon Grove, California, 91945, United States
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Vanda Investigational Site
RECRUITINGOrange, California, 92868, United States
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Vanda Investigational Site
RECRUITINGSan Jose, California, 95124, United States
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Vanda Investigational Site
RECRUITINGWalnut Creek, California, 94596, United States
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Vanda Investigational Site
RECRUITINGColorado Springs, Colorado, 80910, United States
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Vanda Investigational Site
RECRUITINGFort Myers, Florida, 33912, United States
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Vanda Investigational Site
ACTIVE_NOT_RECRUITINGMiami, Florida, 33135, United States
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Vanda Investigational Site
RECRUITINGMiami, Florida, 33173, United States
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Vanda Investigational Site
ACTIVE_NOT_RECRUITINGTampa, Florida, 33614, United States
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Vanda Investigational Site
RECRUITINGChicago, Illinois, 60634, United States
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Vanda Investigational Site
RECRUITINGSaint Charles, Missouri, 63304, United States
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Vanda Investigational Site
RECRUITINGLas Vegas, Nevada, 89119, United States
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Vanda Investigational Site
RECRUITINGNew York, New York, 10035, United States
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Vanda Investigational Site
RECRUITINGStaten Island, New York, 10314, United States
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Vanda Investigational Site
RECRUITINGMedia, Pennsylvania, 19063, United States
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Vanda Investigational Site
RECRUITINGRichardson, Texas, 75080, United States
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Vanda Investigational Site
RECRUITINGWitchita Falls, Texas, 76309, United States
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Vanda Investigational Site
RECRUITINGBellevue, Washington, 98007, United States
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Vanda Investigational Site
RECRUITINGSofia, 1202, Bulgaria
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Vanda Investigational Site
RECRUITINGSofia, 1618, Bulgaria
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Vanda Investigational Site
RECRUITINGSofia, 1680, Bulgaria
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Vanda Investigational Site
RECRUITINGTargovishte, 7700, Bulgaria
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Vanda Investigational Site
RECRUITINGVarna, 9020, Bulgaria
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Vanda Investigational Site
RECRUITINGBrno, 60200, Czechia
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Vanda Investigational Site
RECRUITINGPilsen, 30100, Czechia
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Vanda Investigational Site
RECRUITINGPoruba, 70800, Czechia
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Vanda Investigational Site
RECRUITINGPrague, 100 00, Czechia
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Vanda Investigational Site
RECRUITINGPrague, 15000, Czechia
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Vanda Investigational Site
RECRUITINGPrague, 16000, Czechia
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Vanda Investigational Site
RECRUITINGBialystok, 15-756, Poland
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Vanda Investigational Site
RECRUITINGBydgoszcz, 85-794, Poland
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Vanda Investigational Site
RECRUITINGGdansk, 80-952, Poland
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Vanda Investigational Site
RECRUITINGKatowice, 40-514, Poland
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Vanda Investigational Site
RECRUITINGKatowice, 40-600, Poland
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Vanda Investigational Site
RECRUITINGSuchy Las, 62-002, Poland
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a structured care pathway lift teen depression in primary care?
- Can Anti-Inflammatory drugs lift depression that Won't budge?
- A brain stimulation trial aims to rewire the circuit behind depression
- Can pairing ketamine with talk therapy beat depression alone?
- Genetic matchmaking for antidepressants: a global trial puts personalization to the test
- Could a common vitamin lift depression in young people?