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NCT Number: NCT06830044

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

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

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Key information

Conditions

Major Depressive Disorder (MDD) Depressive Disorder Depressive Disorder, Major Mental Disorders Mood Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Vanda Investigational Site, Sofia, Bulgaria

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Milsaperidone

Drug

Oral milsaperidone

Other names: VHX-896

Placebo

Drug

Oral placebo

Primary outcomes

  1. Change from Baseline in Montgomery-Asberg Depression Rating Scale (MADRS)

    Time frame: 6 weeks

    The MADRS is a clinician-rated 10 item scale. Individual item scores are summed for a total possible score of 0 to 60 with a higher score indicating increased severity of depressive symptoms.

Study contacts

Contact information is provided by the study sponsor or research team.

Vanda Pharmaceuticals

CONTACT

[email protected]

202-734-3400

Sponsors and collaborators

Lead sponsor

Vanda Pharmaceuticals

Industry

Registry information

Official study title

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 dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Feb 17, 2025
Registry last updated
Feb 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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