← Back to Clinical Trials
RecruitingPhase 3NCT06830044

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

◆ AI Clinical Summary
Plain-language summary for patients

Trial Parameters

ConditionMajor Depressive Disorder (MDD)
SponsorVanda Pharmaceuticals
Study TypeINTERVENTIONAL
PhasePhase 3
Enrollment500
SexALL
Min Age18 Years
Max Age65 Years
Start Date2025-03-03
Completion2028-03
Interventions
MilsaperidonePlacebo

Eligibility Fast-Check

Enter your details for a quick preliminary check. This does not replace medical advice.

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

Eligibility 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

Related Trials