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RecruitingPhase 3

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

Vanda Pharmaceuticals · NCT06830044

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18–65 · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Phase 3
Target enrollment
500
US sites recruiting
26
Study start
March 3, 2025
Record last updated
September 24, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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

Being studied: Milsaperidone; Placebo

Conditions: Major Depressive Disorder (MDD)

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full 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

Recruiting US locations

  • Vanda Investigational Site

    Phoenix, AZ 85012

    Site contact: Vanda Pharmaceuticals Inc. · 202-734-3400

  • Vanda Investigational Site

    Little Rock, AR 72211

    Site contact: Vanda Pharmaceuticals Inc. · 202-734-3400

  • Vanda Investigational Site

    Garden Grove, CA 92845

    Site contact: Vanda Pharmaceuticals Inc. · 202-734-3400

  • Vanda Investigational Site

    Orange, CA 92868

    Site contact: Vanda Pharmaceuticals Inc. · 202-734-3400

  • Vanda Investigational Site

    Redlands, CA 92373

    Site contact: Vanda Pharmaceuticals Inc. · 202-734-3400

  • Vanda Investigational Site

    San Jose, CA 95124

    Site contact: Vanda Pharmaceuticals Inc. · 202-734-3400

  • Vanda Investigational Site

    Walnut Creek, CA 94596

    Site contact: Vanda Pharmaceuticals Inc. · 202-734-3400

  • Vanda Investigational Site

    Colorado Springs, CO 80910

    Site contact: Vanda Pharmaceuticals Inc. · 202-734-3400

  • Vanda Investigational Site

    Fort Myers, FL 33912

    Site contact: Vanda Pharmaceuticals Inc. · 202-734-3400

  • Vanda Investigational Site

    Miami, FL 33173

    Site contact: Vanda Pharmaceuticals Inc. · 202-734-3400

  • Vanda Investigational Site

    Snellville, GA 30078

    Site contact: Vanda Pharmaceuticals Inc. · 202-734-3400

  • Vanda Investigational Site

    Chicago, IL 60634

    Site contact: Vanda Pharmaceuticals Inc. · 202-734-3400

  • Vanda Investigational Site

    Carmel, IN 46032

    Site contact: Vanda Pharmaceuticals Inc. · 202-734-3400

  • Vanda Investigational Site

    Boston, MA 02114

    Site contact: Vanda Pharmaceuticals Inc. · 202-734-3400

  • Vanda Investigational Site

    Saint Charles, MO 63304

    Site contact: Vanda Pharmaceuticals Inc. · 202-734-3400

  • Vanda Investigational Site

    Las Vegas, NV 89119

    Site contact: Vanda Pharmaceuticals Inc. · 202-734-3400

  • Vanda Investigational Site

    New York, NY 10035

    Site contact: Vanda Pharmaceuticals Inc. · 202-734-3400

  • Vanda Investigational Site

    New York, NY 10036

    Site contact: Vanda Pharmaceuticals Inc. · 202-734-3400

  • Vanda Investigational Site

    Staten Island, NY 10314

    Site contact: Vanda Pharmaceuticals Inc. · 202-734-3400

  • Vanda Investigational Site

    Charlotte, NC 28211

    Site contact: Vanda Pharmaceuticals Inc. · 202-734-3400

  • Vanda Investigational Site

    Cincinnati, OH 45215

    Site contact: Vanda Pharmaceuticals Inc. · 202-734-3400

  • Vanda Investigational Site

    Houston, TX 77081

    Site contact: Vanda Pharmaceuticals Inc. · 202-734-3400

  • Vanda Investigational Site

    Plano, TX 75093

    Site contact: Vanda Pharmaceuticals Inc. · 202-734-3400

  • Vanda Investigational Site

    Richardson, TX 75080

    Site contact: Vanda Pharmaceuticals Inc. · 202-734-3400

  • Vanda Investigational Site

    Witchita Falls, TX 76309

    Site contact: Vanda Pharmaceuticals Inc. · 202-734-3400

  • Vanda Investigational Site

    Bellevue, WA 98007

    Site contact: Vanda Pharmaceuticals Inc. · 202-734-3400

Study contacts (from the official record)

  • Vanda Pharmaceuticals · 202-734-3400 · clinicaltrials@vandapharma.com
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Evaluation of Efficacy and Safety of Milsaperidone as Adjunctive… (NCT06830044) | Bored Studies