Note: This study is currently only recruiting patients in the hospital.

If you are interested in being notified if this study begins recruiting from the general population, please use the 'I Am Interested' button below.

Postpartum depression study recruiting new moms for an investigational medicine

The Skylark Study is evaluating an oral medicine in women with severe PPD. Researchers are looking for new moms between 18 and 45 years old, less than 12 months postpartum, whose depression symptoms started no earlier than the 3rd trimester

Massachusetts General Hospital Depression Women's Health Postpartum Depression
9 visits over 11 weeks
Estimated Time Commitment
Female, 18-45 years
May Be Eligible
Payment up to $914
May Be Offered
Survey, Personal health tracking, Blood draw, Medication, Office visit
May Be Required
 
I Am Interested I Am Interested I Am Interested

This project is not recruiting.

Who can participate

A participant must meet the following criteria to be eligible for the study: 



  • Is between ages 18 and 45 and less than 12 months postpartum at time of screening 

  • Ceased lactating or agrees not to provide breast milk to her infant(s) starting on Day 1 of the study through 7 days after the last dose of the study medicine. Support for moms is available through the study, including access to lactation consultants, reimbursement for a breast pump, and reimbursement for formula or milk bank donations. 

  • Meets the criteria for a major depressive episode beginning no earlier than the third trimester and no later than the first four weeks following delivery 

  • Those taking antidepressants must be on the same dose for at least 30 days prior to starting the study medicine 


Additional inclusion criteria apply. 

Who cannot participate

A person meeting any of the following criteria will not be eligible for the study:



  • Has a medical history of bipolar disorder, schizophrenia and/or schizoaffective disorder 

  • Has active psychosis per investigator assessment 

  • Has previously participated in a SAGE-217 or SAGE-547 (brexanolone) clinical trial 


Additional exclusion criteria apply. 

What you may be asked to do

Participants will be asked to review their medical history, undergo regular physical examinations including drug and alcohol screens, blood and urine samples, and pregnancy tests all administered by trained study staff. Participants will also discuss their mood and psychiatric health with trained study staff at each study visit. Furthermore, participants will be asked to take their randomized study medicine once daily for 14 days during the study period, using an application to document adherence.


Project activities may include:

  • Survey
  • Personal health tracking
  • Blood draw
  • Medication
  • Office visit

Estimated Time Commitment

9 visits over 11 weeks

What You May Get

Participants will receive $75.00 for every study visit that they complete, as well as a $25.00 gift card for food delivery services after each scheduled visit. Additionally, you may request reimbursement for the following items with valid receipts: 



  • Transportation costs such as fuel, ride share apps, or public transport, up to a value of $50.00 per visit. Additionally, Study staff may schedule Lyft rides to and from the study visit at no cost to the participant. 

  • Childcare during your treatment and follow-up visits, up to $75.00 per visit 

  • Breast pump, up to $250.00 

  • Baby formula, up to $200.00 

  • Donated breast milk from a milk bank may also be available. 


Additionally, each time you successfully use the AiCure medication monitoring app to confirm taking the study medicine, you will receive $1.00, allowing for a maximum payment of $14.00. 

Location


Travel

  • Parking available
  • Parking reimbursed
  • Local travel reimbursed
  • Out of state travel possibly reimbursed
  • Accessible by public transportation

Travel and Parking Details

Park in the Fruit Street or Parkman Street Garage near the main MGH hospital building. Walk up North Grove Street, away from the hospital entrance, and take a left onto Cambridge Street. Walk about 4 blocks up Cambridge Street passing Blossom Street and the Wyndham. The entrance to Charles River Plaza will be on your left. Your parking ticket will be validated by study staff during your study visit. 


See https://womensmentalhealth.org/about/directions/ for more information. 

Additional Information

Project Website

https://womensmentalhealth.org/research/skylark-ppd/


ClinicalTrials.gov Identifier

NCT04442503


Study Phase

Phase 3: This project studies a drug or treatment that has already been studied for safety and effectiveness in both healthy volunteers and participants with specific diseases or conditions. It will gather more information about safety and effectiveness. It may look specifically at different groups of people, different dosages, or different combinations of medications or treatments.


Participating Institutions


Funding Source

  • Industry
Top