NCT06830044

Brief 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

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P50-P75 for phase_3

Timeline
22mo left

Started Mar 2025

Typical duration for phase_3

Geographic Reach
4 countries

38 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress39%
Mar 2025Mar 2028

First Submitted

Initial submission to the registry

February 11, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 17, 2025

Completed
14 days until next milestone

Study Start

First participant enrolled

March 3, 2025

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2028

Last Updated

February 27, 2026

Status Verified

February 1, 2025

Enrollment Period

3 years

First QC Date

February 11, 2025

Last Update Submit

February 25, 2026

Conditions

Major Depressive Disorder (MDD)

Outcome Measures

Primary Outcomes (1)

  • 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.

    6 weeks

Study Arms (2)

Milsaperidone

EXPERIMENTAL
Drug: Milsaperidone

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

MilsaperidoneDRUG

Oral milsaperidone

Also known as: VHX-896
Milsaperidone
PlaceboDRUG

Oral placebo

Placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (38)

Vanda Investigational Site

Phoenix, Arizona, 85012, United States

RECRUITING

Vanda Investigational Site

Little Rock, Arkansas, 72211, United States

RECRUITING

Vanda Investigational Site

Garden Grove, California, 92845, United States

RECRUITING

Vanda Investigational Site

Lemon Grove, California, 91945, United States

RECRUITING

Vanda Investigational Site

Orange, California, 92868, United States

RECRUITING

Vanda Investigational Site

San Jose, California, 95124, United States

RECRUITING

Vanda Investigational Site

Walnut Creek, California, 94596, United States

RECRUITING

Vanda Investigational Site

Colorado Springs, Colorado, 80910, United States

RECRUITING

Vanda Investigational Site

Fort Myers, Florida, 33912, United States

RECRUITING

Vanda Investigational Site

Miami, Florida, 33135, United States

ACTIVE NOT RECRUITING

Vanda Investigational Site

Miami, Florida, 33173, United States

RECRUITING

Vanda Investigational Site

Tampa, Florida, 33614, United States

ACTIVE NOT RECRUITING

Vanda Investigational Site

Chicago, Illinois, 60634, United States

RECRUITING

Vanda Investigational Site

Saint Charles, Missouri, 63304, United States

RECRUITING

Vanda Investigational Site

Las Vegas, Nevada, 89119, United States

RECRUITING

Vanda Investigational Site

New York, New York, 10035, United States

RECRUITING

Vanda Investigational Site

Staten Island, New York, 10314, United States

RECRUITING

Vanda Investigational Site

Media, Pennsylvania, 19063, United States

RECRUITING

Vanda Investigational Site

Richardson, Texas, 75080, United States

RECRUITING

Vanda Investigational Site

Witchita Falls, Texas, 76309, United States

RECRUITING

Vanda Investigational Site

Bellevue, Washington, 98007, United States

RECRUITING

Vanda Investigational Site

Sofia, 1202, Bulgaria

RECRUITING

Vanda Investigational Site

Sofia, 1618, Bulgaria

RECRUITING

Vanda Investigational Site

Sofia, 1680, Bulgaria

RECRUITING

Vanda Investigational Site

Targovishte, 7700, Bulgaria

RECRUITING

Vanda Investigational Site

Varna, 9020, Bulgaria

RECRUITING

Vanda Investigational Site

Brno, 60200, Czechia

RECRUITING

Vanda Investigational Site

Pilsen, 30100, Czechia

RECRUITING

Vanda Investigational Site

Poruba, 70800, Czechia

RECRUITING

Vanda Investigational Site

Prague, 100 00, Czechia

RECRUITING

Vanda Investigational Site

Prague, 15000, Czechia

RECRUITING

Vanda Investigational Site

Prague, 16000, Czechia

RECRUITING

Vanda Investigational Site

Bialystok, 15-756, Poland

RECRUITING

Vanda Investigational Site

Bydgoszcz, 85-794, Poland

RECRUITING

Vanda Investigational Site

Gdansk, 80-952, Poland

RECRUITING

Vanda Investigational Site

Katowice, 40-514, Poland

RECRUITING

Vanda Investigational Site

Katowice, 40-600, Poland

RECRUITING

Vanda Investigational Site

Suchy Las, 62-002, Poland

RECRUITING

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental Disorders

Central Study Contacts

Vanda Pharmaceuticals

CONTACT

202-734-3400clinicaltrials@vandapharma.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 11, 2025

First Posted

February 17, 2025

Study Start

March 3, 2025

Primary Completion (Estimated)

March 1, 2028

Study Completion (Estimated)

March 1, 2028

Last Updated

February 27, 2026

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations

CZ(6)BU(5)US(21)PL(6)