Recruiting

Phase 3

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

Sponsor:

Vanda Pharmaceuticals

Code:

NCT06830044

Conditions

Major Depressive Disorder (MDD)

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Milsaperidone

Placebo

Study Details

Brief 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

Conditions

Major Depressive Disorder (MDD)

Study ID

NCT06830044

Start date

Mar 3, 2025

Status verified date

Feb, 2025

Completion date

Mar, 2028

Anticipated

Primary completion date

Mar, 2028

Anticipated

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

500 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Milsaperidone

placebo comparator: Placebo

Interventions

Milsaperidone

Oral milsaperidone

Placebo

Oral placebo

Primary outcome measure

Change from Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) [ Time Frame: 6 weeks ]

Central Contacts and Locations

Central contacts

Vanda Pharmaceuticals

202-734-3400 clinicaltrials@vandapharma.com

Locations

Vanda Investigational Site

Recruiting

Phoenix, Arizona, United States, 85012

Contacts

Vanda Pharmaceuticals Inc.

202-734-3400

Vanda Investigational Site

Recruiting

Little Rock, Arkansas, United States, 72211

Contacts

Vanda Pharmaceuticals Inc.

202-734-3400

Vanda Investigational Site

Recruiting

Garden Grove, California, United States, 92845

Contacts

Vanda Pharmaceuticals Inc.

202-734-3400

Vanda Investigational Site

Recruiting

Lemon Grove, California, United States, 91945

Contacts

Vanda Pharmaceuticals Inc.

202-734-3400

Vanda Investigational Site

Recruiting

Orange, California, United States, 92868

Contacts

Vanda Pharmaceuticals Inc.

202-734-3400

Vanda Investigational Site

Recruiting

San Jose, California, United States, 95124

Contacts

Vanda Pharmaceuticals Inc.

202-734-3400

Vanda Investigational Site

Recruiting

Walnut Creek, California, United States, 94596

Contacts

Vanda Pharmaceuticals Inc.

202-734-3400

Vanda Investigational Site

Recruiting

Colorado Springs, Colorado, United States, 80910

Contacts

Vanda Pharmaceuticals Inc.

202-734-3400

Vanda Investigational Site

Recruiting

Fort Myers, Florida, United States, 33912

Contacts

Vanda Pharmaceuticals Inc.

202-734-3400

Vanda Investigational Site

Recruiting

Miami, Florida, United States, 33173

Contacts

Vanda Pharmaceuticals Inc.

202-734-3400

Vanda Investigational Site

Recruiting

Chicago, Illinois, United States, 60634

Contacts

Vanda Pharmaceuticals Inc.

202-734-3400

Vanda Investigational Site

Recruiting

Saint Charles, Missouri, United States, 63304

Contacts

Vanda Pharmaceuticals Inc.

202-734-3400

Vanda Investigational Site

Recruiting

Las Vegas, Nevada, United States, 89119

Contacts

Vanda Pharmaceuticals Inc.

202-734-3400

Vanda Investigational Site

Recruiting

New York, New York, United States, 10035

Contacts

Vanda Pharmaceuticals Inc.

202-734-3400

Vanda Investigational Site

Recruiting

Staten Island, New York, United States, 10314

Contacts

Vanda Pharmaceuticals Inc.

202-734-3400

Vanda Investigational Site

Recruiting

Media, Pennsylvania, United States, 19063

Contacts

Vanda Pharmaceuticals Inc.

202-734-3400

Vanda Investigational Site

Recruiting

Richardson, Texas, United States, 75080

Contacts

Vanda Pharmaceuticals Inc.

202-734-3400

Vanda Investigational Site

Recruiting

Witchita Falls, Texas, United States, 76309

Contacts

Vanda Pharmaceuticals Inc.

202-734-3400

Vanda Investigational Site

Recruiting

Bellevue, Washington, United States, 98007

Contacts

Vanda Pharmaceuticals Inc.

202-734-3400

More Information

Sponsor

Vanda Pharmaceuticals

Last update posted

Feb 27, 2026

Last verified

Feb, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Vanda Pharmaceuticals on 2026-02-27.