Major Depressive Disorder (MDD)Phase 3NCT06830044
Evaluation of Efficacy and Safety of Milsaperidone as Adjunctive Therapy in Patients With Major Depressive Disorder
A Phase 3 study testing Milsaperidone in people with Major Depressive Disorder (MDD), run by Vanda Pharmaceuticals at 53 sites in 4 countries.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Major Depressive Disorder (MDD)
- What is being tested?
- Milsaperidone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 500 participants
- Where
- 53 sitesin 4 countries
- Study dates
- 3 Mar 2025to Mar 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
53 sites in 4 countries. Contact the study team or a site near you to ask about taking part.
53 sites in 4 countries
United States29 sites, 26 recruiting
- Recruiting
Vanda Investigational Site
Bellevue, Washington, 98007
Vanda Pharmaceuticals Inc., 202-734-3400
- Recruiting
Vanda Investigational Site
Boston, Massachusetts, 02114
Vanda Pharmaceuticals Inc., 202-734-3400
- Recruiting
Vanda Investigational Site
Carmel, Indiana, 46032
Vanda Pharmaceuticals Inc., 202-734-3400
- Recruiting
Vanda Investigational Site
Charlotte, North Carolina, 28211
Vanda Pharmaceuticals Inc., 202-734-3400
- Recruiting
Vanda Investigational Site
Chicago, Illinois, 60634
Vanda Pharmaceuticals Inc., 202-734-3400
- Recruiting
Vanda Investigational Site
Cincinnati, Ohio, 45215
Vanda Pharmaceuticals Inc., 202-734-3400
- Recruiting
Vanda Investigational Site
Colorado Springs, Colorado, 80910
Vanda Pharmaceuticals Inc., 202-734-3400
- Recruiting
Vanda Investigational Site
Fort Myers, Florida, 33912
Vanda Pharmaceuticals Inc., 202-734-3400
- Recruiting
Vanda Investigational Site
Garden Grove, California, 92845
Vanda Pharmaceuticals Inc., 202-734-3400
- Recruiting
Vanda Investigational Site
Houston, Texas, 77081
Vanda Pharmaceuticals Inc., 202-734-3400
- Recruiting
Vanda Investigational Site
Las Vegas, Nevada, 89119
Vanda Pharmaceuticals Inc., 202-734-3400
- Recruiting
Vanda Investigational Site
Little Rock, Arkansas, 72211
Vanda Pharmaceuticals Inc., 202-734-3400
- Active, not recruiting
Vanda Investigational Site
Media, Pennsylvania, 19063
- Active, not recruiting
Vanda Investigational Site
Miami, Florida, 33135
- Recruiting
Vanda Investigational Site
Miami, Florida, 33173
Vanda Pharmaceuticals Inc., 202-734-3400
- Recruiting
Vanda Investigational Site
New York, New York, 10035
Vanda Pharmaceuticals Inc., 202-734-3400
- Recruiting
Vanda Investigational Site
New York, New York, 10036
Vanda Pharmaceuticals Inc., 202-734-3400
- Recruiting
Vanda Investigational Site
Orange, California, 92868
Vanda Pharmaceuticals Inc., 202-734-3400
- Recruiting
Vanda Investigational Site
Phoenix, Arizona, 85012
Vanda Pharmaceuticals Inc., 202-734-3400
- Recruiting
Vanda Investigational Site
Plano, Texas, 75093
Vanda Pharmaceuticals Inc., 202-734-3400
- Recruiting
Vanda Investigational Site
Redlands, California, 92373
Vanda Pharmaceuticals Inc., 202-734-3400
- Recruiting
Vanda Investigational Site
Richardson, Texas, 75080
Vanda Pharmaceuticals Inc., 202-734-3400
- Recruiting
Vanda Investigational Site
Saint Charles, Missouri, 63304
Vanda Pharmaceuticals Inc., 202-734-3400
- Recruiting
Vanda Investigational Site
San Jose, California, 95124
Vanda Pharmaceuticals Inc., 202-734-3400
- Recruiting
Vanda Investigational Site
Snellville, Georgia, 30078
Vanda Pharmaceuticals Inc., 202-734-3400
- Recruiting
Vanda Investigational Site
Staten Island, New York, 10314
Vanda Pharmaceuticals Inc., 202-734-3400
- Active, not recruiting
Vanda Investigational Site
Tampa, Florida, 33614
- Recruiting
Vanda Investigational Site
Walnut Creek, California, 94596
Vanda Pharmaceuticals Inc., 202-734-3400
- Recruiting
Vanda Investigational Site
Witchita Falls, Texas, 76309
Vanda Pharmaceuticals Inc., 202-734-3400
Bulgaria9 sites, 9 recruiting
- Recruiting
Vanda Investigational Site
Kardzhali, 6600
Vanda Pharmaceuticals Inc., 202-734-3400
- Recruiting
Vanda Investigational Site
Pleven, 5800
Vanda Pharmaceuticals Inc., 202-734-3400
- Recruiting
Vanda Investigational Site
Plovdiv, 4004
Vanda Pharmaceuticals Inc., 202-734-3400
- Recruiting
Vanda Investigational Site
Sofia, 1202
Vanda Pharmaceuticals Inc., 202-734-3400
- Recruiting
Vanda Investigational Site
Sofia, 1618
Vanda Pharmaceuticals Inc., 202-734-3400
- Recruiting
Vanda Investigational Site
Sofia, 1680
Vanda Pharmaceuticals Inc., 202-734-3400
- Recruiting
Vanda Investigational Site
Targovishte, 7700
Vanda Pharmaceuticals Inc., 202-734-3400
- Recruiting
Vanda Investigational Site
Varna, 9020
Vanda Pharmaceuticals Inc., 202-734-3400
- Recruiting
Vanda Investigational Site
Vratsa, 3001
Vanda Pharmaceuticals Inc., 202-734-3400
Poland8 sites, 8 recruiting
- Recruiting
Vanda Investigational Site
Bialystok, 15-756
Vanda Pharmaceuticals Inc., 202-734-3400
- Recruiting
Vanda Investigational Site
Bialystok, 15-879
Vanda Pharmaceuticals Inc., 202-734-3400
- Recruiting
Vanda Investigational Site
Bydgoszcz, 85-794
Vanda Pharmaceuticals Inc., 202-734-3400
- Recruiting
Vanda Investigational Site
Gdansk, 80-952
Vanda Pharmaceuticals Inc., 202-734-3400
- Recruiting
Vanda Investigational Site
Katowice, 40-514
Vanda Pharmaceuticals Inc., 202-734-3400
- Recruiting
Vanda Investigational Site
Katowice, 40-600
Vanda Pharmaceuticals Inc., 202-734-3400
- Recruiting
Vanda Investigational Site
Suchy Las, 62-002
Vanda Pharmaceuticals Inc., 202-734-3400
- Recruiting
Vanda Investigational Site
Torun, 87-100
Vanda Pharmaceuticals Inc., 202-734-3400
Czechia7 sites, 7 recruiting
- Recruiting
Vanda Investigational Site
Brno, 60200
Vanda Pharmaceuticals Inc., 202-734-3400
- Recruiting
Vanda Investigational Site
Pilsen, 30100
Vanda Pharmaceuticals Inc., 202-734-3400
- Recruiting
Vanda Investigational Site
Poruba, 70800
Vanda Pharmaceuticals Inc., 202-734-3400
- Recruiting
Vanda Investigational Site
Prague, 100 00
Vanda Pharmaceuticals Inc., 202-734-3400
- Recruiting
Vanda Investigational Site
Prague, 15000
Vanda Pharmaceuticals Inc., 202-734-3400
- Recruiting
Vanda Investigational Site
Prague, 16000
Vanda Pharmaceuticals Inc., 202-734-3400
- Recruiting
Vanda Investigational Site
Prague, 18600
Vanda Pharmaceuticals Inc., 202-734-3400
About this study
Official title: 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
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
- Major Depressive Disorder (MDD)
- Being tested
- Milsaperidone, Placebo
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MilsaperidoneDrug
Also called VHX-896
Oral milsaperidone
PlaceboDrug
Oral placebo
| Study group | Role | What they receive |
|---|---|---|
| Milsaperidone | Experimental | Not described Receives: Drug: Milsaperidone |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Montgomery-Asberg Depression Rating Scale (MADRS)
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.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2025
- Study start3 Mar 2025
- Primary completionMar 2028 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive Disorder (MDD)Studies of the same condition, open and under way.
- More trials run by Vanda PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vanda Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06830044
- Sponsor's protocol ID
- VP-VHX-896-3201
- Status last verified
- Sep 2026
- First submitted
- 11 Feb 2025
- Last updated
- 24 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06830044
- Acronym / sponsor ID
- VP-VHX-896-3201
- Conditions
- Major Depressive Disorder (MDD)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Vanda PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 3 Mar 2025 (actual)
- Primary completion
- Mar 2028 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 17 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Milsaperidone | Experimental | Drug: Milsaperidone |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MilsaperidoneAlso: VHX-896Oral milsaperidone | Drug | Milsaperidone |
| PlaceboOral placebo | Drug | Placebo |
Primary outcome
Change from Baseline in Montgomery-Asberg Depression Rating Scale (MADRS)
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
53 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Milsaperidone in people with Major Depressive Disorder (MDD), run by Vanda Pharmaceuticals at 53 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 53 sites in United States, Bulgaria, Poland, Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Vanda Pharmaceuticals (202-734-3400, clinicaltrials@vandapharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2026.