- Outpatients who have completed double-blind therapy in a phase 3 DVS-233 SR short-term
study for the indication of MDD, including scheduled evaluations, with no major
protocol 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 acceptable
form of contraception during the trial and for at least 15 days after the last dose of
study drug.
- Clinically important abnormalities on baseline physical examination, or any unresolved
clinically significant abnormalities on ECG, laboratory test results, or vital signs
recorded 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 suicidal
thoughts, and suicide being considered as a possible solution, even without specific
plans or intention.
- Presence of clinically important hepatic or renal disease or other medical disease
that might compromise the study or be detrimental to the subject (eg, clinically
important cardiac arrhythmia, uncontrolled diabetes, uncontrolled hypertension,
seizure disorder, myocardial infarction, neurologic disorder, acute illness,
neoplastic disorder).