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

Phase 3

Recruiting

• Conditions: Major Depressive Disorder (MDD)
• Interventions: Drug: Milsaperidone; Drug: Placebo

• Registration Number: NCT06830044
• Lead Sponsor: Vanda Pharmaceuticals

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-02
• Study First Submitted: 2025-02-11
• Study First Submitted QC: 2025-02-11
• Study First Posted: 2025-02-17
• Study Start: 2025-03-03
• Last Update Submitted: 2025-05-20
• Last Update Posted: 2025-05-25
• Primary Completion: 2028-03
• Study Completion: 2028-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

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 that is a primary diagnosis
• Within 12 months of Screening, has had any other psychiatric condition (other than MDD) that has been the main focus of treatment

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Milsaperidone	Milsaperidone	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Change from Baseline in Montgomery-Asberg Depression Rating Scale (MADRS)	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.

Trial Locations

Locations (1)

Vanda Investigational Site; 🇺🇸 Richardson, Texas, United States