The Skylark study is a research study evaluating an investigational oral medication in women with severe postpartum depression. The purpose of this study is to test the safety and efficacy of an investigational study drug called SAGE-217, a synthetic steroid.
Become Involved with the Research
You may be eligible if you are:
- Are a woman between 18 and 45 years old.
- Gave birth in the last 12 months.
- Frequently feel extremely sad, anxious, or overwhelmed.
- Feel these symptoms are associated with severe postpartum depression.
What Can You Expect?
After a brief telephone screening, if you meet eligibility criteria, you will be asked to do the following:
- Participate in a consenting visit and full screening.
- If eligible, you will be in the study for up to 76 days (up to a 28-day screening period, a 14-day treatment period [when you will take study drug], and a 34-day follow-up period).
- The schedule of the study includes screening, on days 1, 3, 8, 15, 18, 21, 28, and 45.
- Eligible subjects will be randomly (like drawing straws) assigned to receive SAGE-217 50 mg or placebo, that will be taken at home for 14 days. The drug dose can be lowered to 40 mg, if not tolerated.
- During the study subjects will be asked to provide urine and blood samples, undergo pregnancy tests, and drug and alcohol screens, and answer several questionnaires.
- You will need to stop breastfeeding for 3 weeks (2 weeks during medication dosing and 1 week after) and adhere to the birth control requirements for the duration of the study.
Participants are compensated for time and effort.
Participants will also be eligible for reimbursement for childcare, lactation consultation, and will receive meal gift cards at each in office visit.
How Can You Find Out More?
More information about the trial is available at clinicaltrials.gov, on the website of the study’s sponsor, Sage Therapeutics, Inc., and on its Facebook page.
If you are interested in participating in this study, please call 401-793-7824.