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RECRUITINGPhase 3INTERVENTIONAL

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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

Who May Be Eligible (Plain English)

Who May Qualify: - 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) Who Should NOT Join This Trial: - 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

DRUG

Milsaperidone

Oral milsaperidone

DRUG

Placebo

Oral placebo

Locations (20)

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