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

Recruitment Status
RECRUITING
(See Contacts and Locations)Verified January 2025 by Vanda Pharmaceuticals
Sponsor
Vanda Pharmaceuticals
Information Provided by (Responsible Party)
Vanda Pharmaceuticals
Clinicaltrials.gov Identifier
NCT06830044
Other Study ID Numbers:
VP-VHX-896-3201
First Submitted
February 10, 2025
First Posted
February 16, 2025
Last Update Posted
February 26, 2026
Last Verified
January 2025

ClinicalTrials.gov processed this data on February 2026. Link to the current ClinicalTrials.gov record .

History of Changes

Study Details

Study Description

Condition or DiseaseIntervention/Treatment
Major Depressive Disorder (MDD)
Drug: MilsaperidoneDrug: Placebo

Study Design

Study TypeInterventional
Actual Enrollment500 participants
Design AllocationRandomized
Interventional ModelParallel Assignment
MaskingQuadruple
Primary PurposeTreatment
Official TitleA 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
Study Start DateMarch 2, 2025
Actual Primary Completion Date1yr 9mos from now
Actual Study Completion Date1yr 9mos from now

Groups and Cohorts

Group/CohortIntervention/Treatment
Milsaperidone
Drug: Milsaperidone
Oral milsaperidone
Placebo
Drug: Placebo
Oral placebo

Outcome Measures

Primary Outcome Measures
  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.

Eligibility Criteria

Ages Eligible for Study(Adult, Older Adult)
Sexes Eligible for StudyAll
Accepts Healthy VolunteersNo
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

Contacts and Locations

Sponsors and CollaboratorsVanda Pharmaceuticals
Locations
Vanda Investigational Site | Phoenix Arizona, United States, 85012Vanda Investigational Site | Little Rock Arkansas, United States, 72211Vanda Investigational Site | Garden Grove California, United States, 92845Vanda Investigational Site | Lemon Grove California, United States, 91945Vanda Investigational Site | Orange California, United States, 92868Vanda Investigational Site | San Jose California, United States, 95124Vanda Investigational Site | Walnut Creek California, United States, 94596Vanda Investigational Site | Colorado Springs Colorado, United States, 80910Vanda Investigational Site | Fort Myers Florida, United States, 33912Vanda Investigational Site | Miami Florida, United States, 33135Vanda Investigational Site | Miami Florida, United States, 33173Vanda Investigational Site | Tampa Florida, United States, 33614Vanda Investigational Site | Chicago Illinois, United States, 60634Vanda Investigational Site | Saint Charles Missouri, United States, 63304Vanda Investigational Site | Las Vegas Nevada, United States, 89119Vanda Investigational Site | New York New York, United States, 10035Vanda Investigational Site | Staten Island New York, United States, 10314Vanda Investigational Site | Media Pennsylvania, United States, 19063Vanda Investigational Site | Richardson Texas, United States, 75080Vanda Investigational Site | Witchita Falls Texas, United States, 76309Vanda Investigational Site | Bellevue Washington, United States, 98007Vanda Investigational Site | Sofia , Bulgaria, 1202Vanda Investigational Site | Sofia , Bulgaria, 1618Vanda Investigational Site | Sofia , Bulgaria, 1680Vanda Investigational Site | Targovishte , Bulgaria, 7700Vanda Investigational Site | Varna , Bulgaria, 9020Vanda Investigational Site | Brno , Czechia, 60200Vanda Investigational Site | Pilsen , Czechia, 30100Vanda Investigational Site | Poruba , Czechia, 70800Vanda Investigational Site | Prague , Czechia, 100 00Vanda Investigational Site | Prague , Czechia, 15000Vanda Investigational Site | Prague , Czechia, 16000Vanda Investigational Site | Bialystok , Poland, 15-756Vanda Investigational Site | Bydgoszcz , Poland, 85-794Vanda Investigational Site | Gdansk , Poland, 80-952Vanda Investigational Site | Katowice , Poland, 40-514Vanda Investigational Site | Katowice , Poland, 40-600Vanda Investigational Site | Suchy Las , Poland, 62-002