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NCT06830044PHASE3Recruiting

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

Vanda Pharmaceuticals

Start Date

3/3/2025

Completion Date

3/1/2028

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 Criteria

Age Range: 18 years to 65 years

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

Interventions

DRUG

Milsaperidone

DRUG

Placebo

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Conditions

Major Depressive Disorder (MDD)

Locations

Vanda Investigational Site

Phoenix, Arizona 85012

United States

Vanda Investigational Site

Little Rock, Arkansas 72211

United States

Vanda Investigational Site

Garden Grove, California 92845

United States

Vanda Investigational Site

Lemon Grove, California 91945

United States

Vanda Investigational Site

Orange, California 92868

United States

Vanda Investigational Site

San Jose, California 95124

United States

Vanda Investigational Site

Walnut Creek, California 94596

United States

Vanda Investigational Site

Colorado Springs, Colorado 80910

United States

Vanda Investigational Site

Fort Myers, Florida 33912

United States

Vanda Investigational Site

Miami, Florida 33135

United States

Vanda Investigational Site

Miami, Florida 33173

United States

Vanda Investigational Site

Tampa, Florida 33614

United States

Vanda Investigational Site

Chicago, Illinois 60634

United States

Vanda Investigational Site

Saint Charles, Missouri 63304

United States

Vanda Investigational Site

Las Vegas, Nevada 89119

United States

Vanda Investigational Site

New York, New York 10035

United States

Vanda Investigational Site

Staten Island, New York 10314

United States

Vanda Investigational Site

Media, Pennsylvania 19063

United States

Vanda Investigational Site

Richardson, Texas 75080

United States

Vanda Investigational Site

Witchita Falls, Texas 76309

United States

Vanda Investigational Site

Bellevue, Washington 98007

United States

Vanda Investigational Site

Sofia, 1202

Bulgaria

Vanda Investigational Site

Sofia, 1618

Bulgaria

Vanda Investigational Site

Sofia, 1680

Bulgaria

Vanda Investigational Site

Targovishte, 7700

Bulgaria

Vanda Investigational Site

Varna, 9020

Bulgaria

Vanda Investigational Site

Brno, 60200

Czechia

Vanda Investigational Site

Pilsen, 30100

Czechia

Vanda Investigational Site

Poruba, 70800

Czechia

Vanda Investigational Site

Prague, 100 00

Czechia

Vanda Investigational Site

Prague, 15000

Czechia

Vanda Investigational Site

Prague, 16000

Czechia

Vanda Investigational Site

Bialystok, 15-756

Poland

Vanda Investigational Site

Bydgoszcz, 85-794

Poland

Vanda Investigational Site

Gdansk, 80-952

Poland

Vanda Investigational Site

Katowice, 40-514

Poland

Vanda Investigational Site

Katowice, 40-600

Poland

Vanda Investigational Site

Suchy Las, 62-002

Poland