Long-Term Safety Of DVS-233 SR In Patients With Major Depressive Disorder

Inclusion Criteria:

• Outpatients who have completed double-blind therapy in a phase 3 DVS-233 SR short-termstudy for the indication of MDD, including scheduled evaluations, with no majorprotocol violations and no study events that, in the opinion of the investigator,would preclude the subject's entry into the long-term, open-label study.

• Sexually active individuals participating in the study must use a medically acceptableform of contraception during the trial and for at least 15 days after the last dose ofstudy drug.

Exclusion Criteria:

• Clinically important abnormalities on baseline physical examination, or any unresolvedclinically significant abnormalities on ECG, laboratory test results, or vital signsrecorded in a previous phase 3 DVS-233 SR short-term study for the indication of MDD.Any exception must be discussed with and granted by the sponsor.

• Significant risk of suicide based on clinical judgment, including common suicidalthoughts, and suicide being considered as a possible solution, even without specificplans or intention.

• Presence of clinically important hepatic or renal disease or other medical diseasethat might compromise the study or be detrimental to the subject (eg, clinicallyimportant cardiac arrhythmia, uncontrolled diabetes, uncontrolled hypertension,seizure disorder, myocardial infarction, neurologic disorder, acute illness,neoplastic disorder).