Evaluation of Efficacy and Safety of Milsaperidone As Adjunctive Therapy in Patients with Major Depressive Disorder

Vanda Pharmaceuticals

Status and phase: Not yet enrolling; Phase 3

Conditions: Major Depressive Disorder (MDD)

Treatments: Drug: Placebo; Drug: Milsaperidone

Study type: Interventional

Funder types: Industry

Identifiers

NCT06830044

VP-VHX-896-3201

Details and patient eligibility

About

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

Enrollment: 500 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

500 participants in 2 patient groups, including a placebo group

Milsaperidone

Experimental group

Treatment:

Drug: Milsaperidone

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo