← Back to searchRecruitingRecruiting
Evaluation of Efficacy and Safety of Milsaperidone as Adjunctive Therapy in Patients With Major Depressive Disorder
NCT06830044 · Vanda Pharmaceuticals
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
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
About this study
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
Eligibility criteria
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 design
Enrollment target: 500 participants
Allocation: randomized
Masking: quadruple
Age groups: adult, older_adult
Timeline
Starts: 2025-03-03
Estimated completion: 2028-03
Last updated: 2026-02-27
Interventions
Drug: MilsaperidoneDrug: Placebo
Primary outcomes
- • Change from Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) (6 weeks)
Sponsor
Vanda Pharmaceuticals · industry
Contacts & investigators
ContactVanda Pharmaceuticals · contact · clinicaltrials@vandapharma.com · 202-734-3400
All locations (38)
Vanda Investigational SiteRecruiting
Phoenix, Arizona, United States
Vanda Investigational SiteRecruiting
Little Rock, Arkansas, United States
Vanda Investigational SiteRecruiting
Garden Grove, California, United States
Vanda Investigational SiteRecruiting
Lemon Grove, California, United States
Vanda Investigational SiteRecruiting
Orange, California, United States
Vanda Investigational SiteRecruiting
San Jose, California, United States
Vanda Investigational SiteRecruiting
Walnut Creek, California, United States
Vanda Investigational SiteRecruiting
Colorado Springs, Colorado, United States
Vanda Investigational SiteRecruiting
Fort Myers, Florida, United States
Vanda Investigational SiteActive Not Recruiting
Miami, Florida, United States
Vanda Investigational SiteRecruiting
Miami, Florida, United States
Vanda Investigational SiteActive Not Recruiting
Tampa, Florida, United States
Vanda Investigational SiteRecruiting
Chicago, Illinois, United States
Vanda Investigational SiteRecruiting
Saint Charles, Missouri, United States
Vanda Investigational SiteRecruiting
Las Vegas, Nevada, United States
Vanda Investigational SiteRecruiting
New York, New York, United States
Vanda Investigational SiteRecruiting
Staten Island, New York, United States
Vanda Investigational SiteRecruiting
Media, Pennsylvania, United States
Vanda Investigational SiteRecruiting
Richardson, Texas, United States
Vanda Investigational SiteRecruiting
Witchita Falls, Texas, United States
Vanda Investigational SiteRecruiting
Bellevue, Washington, United States
Vanda Investigational SiteRecruiting
Sofia, Bulgaria
Vanda Investigational SiteRecruiting
Sofia, Bulgaria
Vanda Investigational SiteRecruiting
Sofia, Bulgaria
Vanda Investigational SiteRecruiting
Targovishte, Bulgaria
Vanda Investigational SiteRecruiting
Varna, Bulgaria
Vanda Investigational SiteRecruiting
Brno, Czechia
Vanda Investigational SiteRecruiting
Pilsen, Czechia
Vanda Investigational SiteRecruiting
Poruba, Czechia
Vanda Investigational SiteRecruiting
Prague, Czechia
Vanda Investigational SiteRecruiting
Prague, Czechia
Vanda Investigational SiteRecruiting
Prague, Czechia
Vanda Investigational SiteRecruiting
Bialystok, Poland
Vanda Investigational SiteRecruiting
Bydgoszcz, Poland
Vanda Investigational SiteRecruiting
Gdansk, Poland
Vanda Investigational SiteRecruiting
Katowice, Poland
Vanda Investigational SiteRecruiting
Katowice, Poland
Vanda Investigational SiteRecruiting
Suchy Las, Poland