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

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

Who can join

Ages 18 to 65 · All sexes

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

About the 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

What is being tested

• Milsaperidone (drug)
• Placebo (drug)

Sponsor: Vanda Pharmaceuticals · Participants: 500 · Started: Mar 3, 2025

Contact the study team

• Vanda Pharmaceuticals · Phone: 202-734-3400

Official record on ClinicalTrials.gov — NCT06830044

Locations in the U.S.

Conditions

• Major Depressive Disorder

From ClinicalTrials.gov, data retrieved Sep 29, 2026. Each study sets its own eligibility; the study team decides who can join.