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

Recruiting now · Phase 3 · Has a placebo group

Conditions studied: Major Depressive Disorder (MDD)

In brief

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

Key facts

Study ID

NCT06830044

Run by

Vanda Pharmaceuticals

People needed

500

Starts

2025-03-03

Expected to finish

2028-03-01

Last updated by the study team

2026-02-27

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• Vanda Investigational Site — Suchy Las, Poland (enrolling)
• Vanda Investigational Site — Little Rock, Arkansas, United States (enrolling)
• Vanda Investigational Site — Garden Grove, California, United States (enrolling)
• Vanda Investigational Site — Lemon Grove, California, United States (enrolling)
• Vanda Investigational Site — Orange, California, United States (enrolling)
• Vanda Investigational Site — San Jose, California, United States (enrolling)
• Vanda Investigational Site — Walnut Creek, California, United States (enrolling)
• Vanda Investigational Site — Colorado Springs, Colorado, United States (enrolling)
• Vanda Investigational Site — Fort Myers, Florida, United States (enrolling)
• Vanda Investigational Site — Katowice, Poland (enrolling)
• Vanda Investigational Site — Phoenix, Arizona, United States (enrolling)
• Vanda Investigational Site — Miami, Florida, United States (enrolling)
• Vanda Investigational Site — Chicago, Illinois, United States (enrolling)
• Vanda Investigational Site — Saint Charles, Missouri, United States (enrolling)
• Vanda Investigational Site — Las Vegas, Nevada, United States (enrolling)
• Vanda Investigational Site — New York, New York, United States (enrolling)
• Vanda Investigational Site — Staten Island, New York, United States (enrolling)
• Vanda Investigational Site — Media, Pennsylvania, United States (enrolling)
• Vanda Investigational Site — Richardson, Texas, United States (enrolling)
• Vanda Investigational Site — Witchita Falls, Texas, United States (enrolling)
• Vanda Investigational Site — Bellevue, Washington, United States (enrolling)
• Vanda Investigational Site — Sofia, Bulgaria (enrolling)
• Vanda Investigational Site — Sofia, Bulgaria (enrolling)
• Vanda Investigational Site — Sofia, Bulgaria (enrolling)
• Vanda Investigational Site — Targovishte, Bulgaria (enrolling)

Full record on ClinicalTrials.gov

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