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

February 25, 2026 updated by: Vanda Pharmaceuticals

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

500

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Bulgaria
      • Sofia, Bulgaria, 1680
        • Recruiting
        • Vanda Investigational Site
        • Contact:
          • Vanda Pharmaceuticals Inc.
          • Phone Number: 202-734-3400
      • Sofia, Bulgaria, 1202
        • Recruiting
        • Vanda Investigational Site
        • Contact:
          • Vanda Pharmaceuticals Inc.
          • Phone Number: 202-734-3400
      • Sofia, Bulgaria, 1618
        • Recruiting
        • Vanda Investigational Site
        • Contact:
          • Vanda Pharmaceuticals Inc.
          • Phone Number: 202-734-3400
      • Targovishte, Bulgaria, 7700
        • Recruiting
        • Vanda Investigational Site
        • Contact:
          • Vanda Pharmaceuticals Inc.
          • Phone Number: 202-734-3400
      • Varna, Bulgaria, 9020
        • Recruiting
        • Vanda Investigational Site
        • Contact:
          • Vanda Pharmaceuticals Inc.
          • Phone Number: 202-734-3400
  • Czechia
      • Brno, Czechia, 60200
        • Recruiting
        • Vanda Investigational Site
        • Contact:
          • Vanda Pharmaceuticals Inc.
          • Phone Number: 202-734-3400
      • Pilsen, Czechia, 30100
        • Recruiting
        • Vanda Investigational Site
        • Contact:
          • Vanda Pharmaceuticals Inc.
          • Phone Number: 202-734-3400
      • Poruba, Czechia, 70800
        • Recruiting
        • Vanda Investigational Site
        • Contact:
          • Vanda Pharmaceuticals Inc.
          • Phone Number: 202-734-3400
      • Prague, Czechia, 100 00
        • Recruiting
        • Vanda Investigational Site
        • Contact:
          • Vanda Pharmaceuticals Inc.
          • Phone Number: 202-734-3400
      • Prague, Czechia, 15000
        • Recruiting
        • Vanda Investigational Site
        • Contact:
          • Vanda Pharmaceuticals Inc.
          • Phone Number: 202-734-3400
      • Prague, Czechia, 16000
        • Recruiting
        • Vanda Investigational Site
        • Contact:
          • Vanda Pharmaceuticals Inc.
          • Phone Number: 202-734-3400
  • Poland
      • Bialystok, Poland, 15-756
        • Recruiting
        • Vanda Investigational Site
        • Contact:
          • Vanda Pharmaceuticals Inc.
          • Phone Number: 202-734-3400
      • Bydgoszcz, Poland, 85-794
        • Recruiting
        • Vanda Investigational Site
        • Contact:
          • Vanda Pharmaceuticals Inc.
          • Phone Number: 202-734-3400
      • Gdansk, Poland, 80-952
        • Recruiting
        • Vanda Investigational Site
        • Contact:
          • Vanda Pharmaceuticals Inc.
          • Phone Number: 202-734-3400
      • Katowice, Poland, 40-514
        • Recruiting
        • Vanda Investigational Site
        • Contact:
          • Vanda Pharmaceuticals Inc.
          • Phone Number: 202-734-3400
      • Katowice, Poland, 40-600
        • Recruiting
        • Vanda Investigational Site
        • Contact:
          • Vanda Pharmaceuticals Inc.
          • Phone Number: 202-734-3400
      • Suchy Las, Poland, 62-002
        • Recruiting
        • Vanda Investigational Site
        • Contact:
          • Vanda Pharmaceuticals Inc.
          • Phone Number: 202-734-3400
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85012
        • Recruiting
        • Vanda Investigational Site
        • Contact:
          • Vanda Pharmaceuticals Inc.
          • Phone Number: 202-734-3400
    • Arkansas
      • Little Rock, Arkansas, United States, 72211
        • Recruiting
        • Vanda Investigational Site
        • Contact:
          • Vanda Pharmaceuticals Inc.
          • Phone Number: 202-734-3400
    • California
      • Garden Grove, California, United States, 92845
        • Recruiting
        • Vanda Investigational Site
        • Contact:
          • Vanda Pharmaceuticals Inc.
          • Phone Number: 202-734-3400
      • Lemon Grove, California, United States, 91945
        • Recruiting
        • Vanda Investigational Site
        • Contact:
          • Vanda Pharmaceuticals Inc.
          • Phone Number: 202-734-3400
      • Orange, California, United States, 92868
        • Recruiting
        • Vanda Investigational Site
        • Contact:
          • Vanda Pharmaceuticals Inc.
          • Phone Number: 202-734-3400
      • San Jose, California, United States, 95124
        • Recruiting
        • Vanda Investigational Site
        • Contact:
          • Vanda Pharmaceuticals Inc.
          • Phone Number: 202-734-3400
      • Walnut Creek, California, United States, 94596
        • Recruiting
        • Vanda Investigational Site
        • Contact:
          • Vanda Pharmaceuticals Inc.
          • Phone Number: 202-734-3400
    • Colorado
      • Colorado Springs, Colorado, United States, 80910
        • Recruiting
        • Vanda Investigational Site
        • Contact:
          • Vanda Pharmaceuticals Inc.
          • Phone Number: 202-734-3400
    • Florida
      • Fort Myers, Florida, United States, 33912
        • Recruiting
        • Vanda Investigational Site
        • Contact:
          • Vanda Pharmaceuticals Inc.
          • Phone Number: 202-734-3400
      • Miami, Florida, United States, 33173
        • Recruiting
        • Vanda Investigational Site
        • Contact:
          • Vanda Pharmaceuticals Inc.
          • Phone Number: 202-734-3400
      • Miami, Florida, United States, 33135
        • Active, not recruiting
        • Vanda Investigational Site
      • Tampa, Florida, United States, 33614
        • Active, not recruiting
        • Vanda Investigational Site
    • Illinois
      • Chicago, Illinois, United States, 60634
        • Recruiting
        • Vanda Investigational Site
        • Contact:
          • Vanda Pharmaceuticals Inc.
          • Phone Number: 202-734-3400
    • Missouri
      • Saint Charles, Missouri, United States, 63304
        • Recruiting
        • Vanda Investigational Site
        • Contact:
          • Vanda Pharmaceuticals Inc.
          • Phone Number: 202-734-3400
    • Nevada
      • Las Vegas, Nevada, United States, 89119
        • Recruiting
        • Vanda Investigational Site
        • Contact:
          • Vanda Pharmaceuticals Inc.
          • Phone Number: 202-734-3400
    • New York
      • New York, New York, United States, 10035
        • Recruiting
        • Vanda Investigational Site
        • Contact:
          • Vanda Pharmaceuticals Inc.
          • Phone Number: 202-734-3400
      • Staten Island, New York, United States, 10314
        • Recruiting
        • Vanda Investigational Site
        • Contact:
          • Vanda Pharmaceuticals Inc.
          • Phone Number: 202-734-3400
    • Pennsylvania
      • Media, Pennsylvania, United States, 19063
        • Recruiting
        • Vanda Investigational Site
        • Contact:
          • Vanda Pharmaceuticals Inc.
          • Phone Number: 202-734-3400
    • Texas
      • Richardson, Texas, United States, 75080
        • Recruiting
        • Vanda Investigational Site
        • Contact:
          • Vanda Pharmaceuticals Inc.
          • Phone Number: 202-734-3400
      • Witchita Falls, Texas, United States, 76309
        • Recruiting
        • Vanda Investigational Site
        • Contact:
          • Vanda Pharmaceuticals Inc.
          • Phone Number: 202-734-3400
    • Washington
      • Bellevue, Washington, United States, 98007
        • Recruiting
        • Vanda Investigational Site
        • Contact:
          • Vanda Pharmaceuticals Inc.
          • Phone Number: 202-734-3400

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
Oral placebo
Experimental: Milsaperidone
Drug: Milsaperidone
Oral milsaperidone
Other Names:
  • VHX-896

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vanda Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 3, 2025

Primary Completion (Estimated)

March 1, 2028

Study Completion (Estimated)

March 1, 2028

Study Registration Dates

First Submitted

February 11, 2025

First Submitted That Met QC Criteria

February 11, 2025

First Posted (Actual)

February 17, 2025

Study Record Updates

Last Update Posted (Actual)

February 27, 2026

Last Update Submitted That Met QC Criteria

February 25, 2026

Last Verified

February 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VP-VHX-896-3201

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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