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

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 bythe Investigator using the Antidepressant Treatment Response Questionnaire (ATRQ)

Exclusion Criteria:

• Within the patients lifetime, has a confirmed DSM-5-TR psychiatric diagnosis otherthan MDD

• Within 6 months of Screening, has a confirmed DSM-5-TR psychiatric diagnosis otherthan MDD

• Within 12 months of Screening, has had any other psychiatric condition (other thanMDD) that has been the main focus of treatment