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

RECRUITINGPhase 3Sponsored by Vanda Pharmaceuticals

Actively Recruiting

PhasePhase 3

SponsorVanda Pharmaceuticals

Started2025-03-03

Est. completion2028-03

Eligibility

Age18 Years – 65 Years

Healthy vol.Accepted

Locations21 sites

View on ClinicalTrials.gov →

NCT06830044

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

Age: 18 Years – 65 YearsHealthy volunteers 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

Conditions2

DepressionMajor Depressive Disorder (MDD)

Interventions1

Milsaperidone