Summary:
The SAVITRI Study is evaluating the safety and effectiveness of a once-daily oral investigational medication on improving symptoms of MDD in patients who are having an inadequate response to antidepressant medication(s).
The total length of the SAVITRI Study is approximately 14 weeks. This includes a 4-week screening period to make sure the research study is a good match for you, an 8-week treatment period in which you will receive 1 of 2 doses of the investigational medication or the placebo, and a 2-week follow-up period to check on your health after stopping the assigned study treatment.
Individuals will be evaluated to determine their eligibility to participate. Each patient who qualifies will receive the investigational medication or the placebo, as well as study-related medical exams and study-related laboratory tests, all at no cost. Participants will be able to stay on their current antidepressant medication(s).
Eligibility Criteria:
Eligible participants must:
- Be 18 to 65 years of age (inclusive)
- Have a confirmed diagnosis of MDD
- Be currently on antidepressant medication(s)
- Have had inadequate response to up to 5 oral antidepressant medications
- Not be pregnant or breastfeeding
- Not have a current psychiatric disorder other than MDD
Other protocol-defined inclusion and exclusion criteria may apply.