Summary:
The TERPSIS Study is evaluating the safety and effectiveness of a once-weekly oral investigational medication on improving the lack or loss of interest in usually pleasurable activities in participants with MDD.
The total length of the TERPSIS Study is approximately 20 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 either the investigational medication or placebo, and an 8-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:
For the TERPSIS Study, eligible participants must:
- Be 18 to 65 years of age (inclusive)
- Have a confirmed diagnosis of MDD
- Be currently on antidepressant medication(s)
- Not be pregnant or breastfeeding
- Not have a current psychiatric disorder other than MDD
Other protocol-defined inclusion and exclusion criteria may apply.