Learn About Postpartum Depression (PPD)
Being a new mom comes with many joys as well as challenges. But when symptoms of PPD, such as extreme sadness, severe anxiety, and hopelessness, cloud everything in your life, you need to do something about it. After all, caring for yourself is as important as caring for your new baby and the rest of your family.
PPD is one of the most common medical complications during and after pregnancy.1, 2 During pregnancy, the levels of certain hormones rise and then rapidly fall after giving birth. Among other factors, these hormonal fluctuations have been associated with developing PPD symptoms.3
Symptoms may include:4, 5
- Sadness, tearfulness, or hopelessness
- Outbursts or irritability, even over small matters
- Worrying or feeling overly anxious
- Oversleeping, or being unable to sleep even when your baby is asleep
- Feelings of worthlessness or guilt
- Trouble bonding with your baby
- Thoughts of harming yourself or your baby
If you are experiencing symptoms of PPD or have been diagnosed with PPD, you may qualify for the SKYLARK STUDY. Learn more about this study and discuss possible participation with your doctor.
- Ko JY, Rockhill KM, Tong VT, Morrow B, Farr SL. Trends in Postpartum Depressive Symptoms - 27 States, 2004, 2008, and 2012. MMWR Morb Mortal Wkly Rep. 2017;66 (6 ):153-158.
- The American College of Ob and Gyn. Screening for Perinatal Depression. May 2015.
- Payne JL, Frontiers in Neuroendocrinology,https://doi.org/10.1016/j.yfrne.2018.12.001.
- American Psychiatric Association: Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition. Arlington, VA: American Psychiatric Association, 2013.
- National Institute of Mental Health. Accessed July 13, 2020. https://www.nimh.nih.gov/health/publications/perinatal-depression/index.shtml.
About the SKYLARK STUDY
The SKYLARK STUDY is evaluating the efficacy and safety of an investigational oral medication in women with severe PPD. An investigational medication is a study drug that will be tested during a clinical research study to see if it is safe and effective for a specific condition and/or group of people.
If you are eligible and decide to participate, you will be asked to take the assigned investigational oral medication at home every night for 14 days. You’ll come into the study site 4 times while on the investigational oral medication and 4 times during the follow-up period. Your total participation will last about 76 days.
You will not be able to breastfeed during the study. If you would like information about starting and stopping breastfeeding, the study staff can arrange for you to meet with a breastfeeding specialist (lactation consultant) at no cost. They may be able to give you information about feeding your baby during the study and ways to maintain your milk supply if you would like to continue breastfeeding after the study. Additionally, if you need a breast pump, donated breastmilk from a milk bank, baby formula, and/or assistance with childcare during the treatment or follow-up phases, you may submit documentation of out-of-pocket expenses for reimbursement.
To see if you may be eligible, please take the prescreener. If you prequalify, a study representative will follow up with you to schedule a screening visit to discuss additional details and help answer any questions you may have.
Study Eligibility is determined during the screening visit. During the visit you will:
- Meet with the study doctor and staff
- Review additional information
- Have an initial evaluation
- Complete the study questionnaires
If you participate in the SKYLARK STUDY, your PPD symptoms will be monitored by qualified study staff (nurses and other clinicians), under the guidance of the study doctor. You will also receive study-related medical care and the assigned investigational oral medication at no cost.
How Do I Qualify?
To be eligible for the study you must:
- Be 18 to 45 years of age
- Have given birth within the last 6 months
- Frequently feel extremely sad, anxious, or overwhelmed, and these symptoms are associated with severe PPD
- Have symptoms that began no earlier than the third trimester and no later than the first 4 weeks following delivery
The study doctor will discuss additional requirements.
Your participation in the SKYLARK STUDY is completely voluntary. If you decide to participate in this research study, you are always free to withdraw at any time for any reason without any penalty or effect on your future medical care.
If you are eligible and decide to participate:
- A study doctor will closely monitor you and your PPD symptoms
- All study-related medical care and assigned investigation oral medication will be provided at no cost
- Participants may receive reasonable compensation for their time and travel
- If you are currently taking antidepressants, you may be able to stay on your current depression medication during the study
Frequently Asked Questions
This section will help answer some of the important questions you may have.
The SKYLARK STUDY includes a Screening Period, Study Treatment Period, and Follow-up Period.
- Screening Period: The purpose of the Screening Period is to determine whether you meet the requirements to take part in the study. You will go through a set of interviews at the study office, answer questions about your health and symptoms, and have some laboratory assessments done. The study doctor will review all these results to determine your eligibility.
- Study Treatment Period: If you are eligible and decide to enroll in the study, you will take the assigned investigational oral medication at home every day for 14 days. You will also have 4 visits to the study office during this time. You will complete various questionnaires and laboratory tests to help the study doctor evaluate your health and symptoms.
- Follow-up Period: After the Study Treatment Period, you will come back to the study office for 4 follow-up visits over about 4 weeks.
If you prequalify and are referred to a research site, the study staff can provide you with more information.
Participants who are breastfeeding must temporarily stop for 21 days – from just before starting the assigned investigational oral medication through 7 days after you stop taking the assigned investigational oral medication. You may start breastfeeding again after the 21-day period. If you would like information about starting and stopping breastfeeding, the study staff can arrange for you to meet with a breastfeeding specialist (lactation consultant) at no cost. They may be able to give you information about feeding your baby during the study and ways to maintain your milk supply if you would like to continue breastfeeding after the study. Additionally, if you need a breast pump, donated breastmilk from a milk bank, baby formula, and/or assistance with childcare during the treatment or follow-up phases, you may submit documentation of out-of-pocket expenses for reimbursement.
All study-related medical care and the assigned investigational oral medication will be provided at no cost. Reasonable compensation may be provided for time and travel.
Yes, your participation in any research study is completely voluntary. If you decide to participate in a research study, you are always free to withdraw at any time for any reason without any effect on your future medical care.
No, your doctor doesn’t have to give you permission to participate. But feel free to talk to your doctor about participating in the study. With your permission, the study doctor will keep your regular doctor updated about your condition during the study.
The information you provide will not be shared with anyone who is not directly associated with this research study without your permission (except as required by law) or as outlined in the informed consent.
A clinical research study, also called a clinical trial, evaluates the safety and efficacy of an investigational medication to find out if it is better than, as good as, or no better than placebo. It is only through the completion of research studies that the investigational medication can be evaluated and, if proven safe and effective, approved for use for the condition that was studied. Research studies are performed according to government regulations that help protect the safety and rights of the participants.
An investigational medication is not approved for use or prescription by doctors for the condition being studied. Investigational medications are tested during clinical research studies to see if they are safe and effective for a specific medical condition and/or group of people.
You could experience side effects associated with the investigational oral medication. There are also risks associated with some of the study procedures. The symptoms may not improve or may get worse during the research study. The doctor or study staff will discuss all of the possible risks and potential benefits in detail with you.
Informed consent is the process of learning the key facts about a research study before you decide to participate. It is also a continuing process throughout the study to provide information to participants. To help you decide whether or not to participate, the doctors and nurses involved in the research study will explain the details of the study. The study team will then provide you with an informed consent form to read. The document includes details about the study, such as its purpose, duration, and required procedures. Risks and potential benefits are also explained in the informed consent form. After you have received and read the information about the study and reviewed any questions with the study doctor, you will then decide whether or not to sign the document. No study-related procedures can take place before you have signed the informed consent form. The informed consent form is not a contract, and you may withdraw from the research study at any time.
The SKYLARK STUDY is evaluating the efficacy and safety of an investigational oral medication in treatment of women with severe postpartum depression (PPD) who have recently given birth.
Sage Therapeutics, Inc. is sponsoring the SKYLARK STUDY.
To help ensure that a research study is ethical, and that participants’ rights are protected, Institutional Review Boards (IRB) or Ethics Committees (EC) review study protocols.