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Evaluating milsaperidone for treating 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

Phase 3 Interventional Vanda Pharmaceuticals · NCT06830044

This study is testing if adding milsaperidone to the treatment plan can help people with major depressive disorder who haven't felt better with their current antidepressants.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment500 (estimated)
Ages18 Years to 65 Years
SexAll
SponsorVanda Pharmaceuticals Industry-sponsored
Locations38 sites (Phoenix, Arizona and 37 other locations)
Trial IDNCT06830044 on ClinicalTrials.gov

What this trial studies

This study aims to assess the efficacy and safety of milsaperidone as an adjunctive therapy for patients diagnosed with Major Depressive Disorder (MDD) who have not responded adequately to current antidepressant treatments. Participants will be randomly assigned to receive either milsaperidone or a placebo, with their responses monitored over the course of the trial. The study will utilize the Antidepressant Treatment Response Questionnaire to confirm inadequate response to existing therapies. The goal is to determine if milsaperidone can provide additional benefits in managing MDD symptoms.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 65 who meet the criteria for MDD and have not responded adequately to current antidepressant treatments.

Not a fit: Patients with other primary psychiatric diagnoses or those who have had significant psychiatric conditions in the past year may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could offer new hope for patients with MDD who have not found relief with standard antidepressant therapies.

How similar studies have performed: While this approach is being evaluated in this trial, similar studies have shown promise in exploring adjunctive therapies for MDD.

Eligibility criteria

Show full inclusion / exclusion 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

Where this trial is running

Phoenix, Arizona and 37 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Major Depressive Disorder
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.