RecruitingPhase 3NCT06830044

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

Sponsor

Vanda Pharmaceuticals

Enrollment

500 participants

Start Date

Mar 3, 2025

Study Type

INTERVENTIONAL

Conditions

Major Depressive Disorder (MDD)

Summary

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

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study is testing milsaperidone — an experimental medication — as an add-on therapy for people with major depressive disorder (MDD) whose current antidepressant is not working well enough on its own. **You may be eligible if...** - You are between 18 and 65 years old - You have been diagnosed with major depressive disorder (MDD) according to DSM-5-TR criteria - Your current antidepressant treatment is not providing enough relief (inadequate response, confirmed by your doctor using a standard questionnaire) **You may NOT be eligible if...** - You have ever been diagnosed with another psychiatric condition besides MDD (such as bipolar disorder, schizophrenia, or PTSD) - You have had any other psychiatric condition in the past 6 to 12 months - You have significant heart, liver, or kidney problems - You are at high risk of suicide - You are pregnant or breastfeeding - You use recreational drugs or alcohol heavily Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGMilsaperidone

Oral milsaperidone

DRUGPlacebo

Oral placebo

Locations(38)

Vanda Investigational Site

Phoenix, Arizona, United States

Vanda Investigational Site

Little Rock, Arkansas, United States

Vanda Investigational Site

Garden Grove, California, United States

Vanda Investigational Site

Lemon Grove, California, United States

Vanda Investigational Site

Orange, California, United States

Vanda Investigational Site

San Jose, California, United States

Vanda Investigational Site

Walnut Creek, California, United States

Vanda Investigational Site

Colorado Springs, Colorado, United States

Vanda Investigational Site

Fort Myers, Florida, United States

Vanda Investigational Site

Miami, Florida, United States

Vanda Investigational Site

Miami, Florida, United States

Vanda Investigational Site

Tampa, Florida, United States

Vanda Investigational Site

Chicago, Illinois, United States

Vanda Investigational Site

Saint Charles, Missouri, United States

Vanda Investigational Site

Las Vegas, Nevada, United States

Vanda Investigational Site

New York, New York, United States

Vanda Investigational Site

Staten Island, New York, United States

Vanda Investigational Site

Media, Pennsylvania, United States

Vanda Investigational Site

Richardson, Texas, United States

Vanda Investigational Site

Witchita Falls, Texas, United States

Vanda Investigational Site

Bellevue, Washington, United States

Vanda Investigational Site

Sofia, Bulgaria

Vanda Investigational Site

Sofia, Bulgaria

Vanda Investigational Site

Sofia, Bulgaria

Vanda Investigational Site

Targovishte, Bulgaria

Vanda Investigational Site

Varna, Bulgaria

Vanda Investigational Site

Brno, Czechia

Vanda Investigational Site

Pilsen, Czechia

Vanda Investigational Site

Poruba, Czechia

Vanda Investigational Site

Prague, Czechia

Vanda Investigational Site

Prague, Czechia

Vanda Investigational Site

Prague, Czechia

Vanda Investigational Site

Bialystok, Poland

Vanda Investigational Site

Bydgoszcz, Poland

Vanda Investigational Site

Gdansk, Poland

Vanda Investigational Site

Katowice, Poland

Vanda Investigational Site

Katowice, Poland

Vanda Investigational Site

Suchy Las, Poland

View Full Details on ClinicalTrials.gov

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NCT06830044

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