RecruitingPhase 3NCT06830044
Evaluation of Efficacy and Safety of Milsaperidone as Adjunctive Therapy in Patients With Major Depressive Disorder
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
Sponsor
Vanda Pharmaceuticals
Enrollment
500 participants
Start Date
Mar 3, 2025
Study Type
INTERVENTIONAL
Conditions
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
Min Age: 18 YearsMax Age: 65 Years
Inclusion Criteria3
- 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 Criteria3
- 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
Interventions
DRUGMilsaperidone
Oral milsaperidone
DRUGPlacebo
Oral placebo
Locations(38)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06830044
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