See if you pre-qualify—call (844) 901-0101 or text MOM1 to 87888
You’re struggling, filled with anxiety and withdrawn from your baby. It’s not your fault.
Postpartum depression symptoms are serious and shouldn’t be ignored. Consider participating in the Hummingbird Study, a research study evaluating an investigational medication in women with moderate to severe postpartum depression.
See if you pre-qualify—
- call (844) 901-0101
- or text MOM1 to 87888
About Postpartum Depression
Postpartum depression is a biological complication of pregnancy. During pregnancy, levels of certain hormones rise and then rapidly fall after giving birth.1 However, in some women, these hormone shifts may contribute to postpartum depression. You are not alone. Up to 20% of women experience postpartum depression following childbirth.2
Postpartum depression symptoms may include:
- Feelings of sadness, tearfulness, emptiness or hopelessness
- Angry outbursts, irritability or frustration, even over small matters
- Anxiety, agitation or restlessness
- Loss of interest or pleasure in most or all normal activities
- Changes in appetite
- Feelings of worthlessness or guilt, fixating on past failures or blaming yourself for things that aren’t your responsibility
- Trouble bonding with your baby
- Thoughts of harming yourself or your baby
Help identify the warning signs
It can be difficult to watch someone struggling after childbirth. But postpartum depression is more common than you think and, because of the social stigma related to it, may not be diagnosed or identified and mothers of newborns often suffer in silence.
During pregnancy, levels of certain hormones rise and then rapidly fall after giving birth. In some women, these hormone shifts may contribute to postpartum depression, which requires professional attention. Learn how to identify the warning signs, offer support and give reassurance by downloading this guide.Support her by learning more
Up to 20% of women experience postpartum depression after childbirth.2
About the Hummingbird Study
The purpose of the Hummingbird Study is to evaluate the safety and effectiveness of an investigational medication in women with moderate to severe postpartum depression. This research study lasts about 37 days, including a 3-day, in-patient hospital stay and four follow-up visits. If you are breastfeeding, you must stop temporarily.
If you qualify and decide to participate, you will receive:
- Study-related medical care during the 3-day, in-patient period
- All study-related medical care and medication provided at no cost
- Transportation may be provided for those who require assistance
How do I qualify?
Qualified participants must meet these eligibility requirements*:
- Between 18 to 45 years old
- Gave birth within the last 6 months
- Frequently feel extremely sad, anxious or overwhelmed and these symptoms are associated with postpartum depression
* Note: The study doctor will discuss additional requirements.
Frequently Asked Questions
- Why is this study being conducted?
The Hummingbird Study is evaluating the safety in and effectiveness of an investigational medication in women with moderate to severe postpartum depression who have recently given birth. About 220 women will be enrolled in the study.
- What can I expect if I participate in this study?
The study lasts about 37 days, including a 3-day, in-patient hospital stay during which you will receive the study medication or placebo by IV infusion and be continually monitored. Your vital signs will be checked frequently and you will complete various questionnaires to help evaluate your health and symptoms. After the in-patient period, you will come back to the study office for 4 follow-up visits - 7 days, 14 days, 21 days and 30 days after the study medication is first administered.
- Does my doctor need to give me permission to participate in this study?
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.
- Can I breastfeed during this study?
Participants must temporarily stop breastfeeding or giving breastmilk to their infants immediately before starting the study in-patient period through 9 days after the end of the study drug administration. You may start breastfeeding again after the 9-day period
- Will I have to pay for anything if I choose to participate in this study?
All study-related medication and medical care will be provided at no cost. Any travel required to participate will be coordinated and paid for by Sage Therapeutics.
- Who is sponsoring this study?
Sage Therapeutics is sponsoring the Hummingbird Study.
- What is a clinical research study?
A research study, also called a clinical trial, evaluates the safety and effectiveness of an investigational medication to know 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.
- What is an investigational medication?
An investigational medication is a study drug that is not approved for use or prescription by doctors for the condition being studied. Investigational medications are tested during research studies to see if they are safe and effective for a specific medical condition and/or group of people.
- What is a placebo?
Placebos are inactive substances made to look like the study medication used in the research study. Placebos allow the investigators to learn whether the medicine being given works better or no better than ordinary treatment alone or no treatment. In this study, you will be randomly assigned by chance to receive either SAGE-547 (brexanolone [USAN]) or placebo (inactive substance). Neither you nor the study doctor will know to which of these groups you have been assigned. There is a chance that you will receive a placebo during this research study.
- Is my participation in this research study voluntary?
Yes, your participation in any medical research study is completely voluntary. If you decide to participate in a medical research study, you are always free to withdraw at any time for any reason without any penalty or effect on your future medical care.
- What are the risks of participating in a research study?
You could experience side effects associated with the investigational 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.
- What is informed consent?
Informed consent is the process of learning the key facts about a clinical 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 clinical 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 clinical research study, 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 clinical research study at any time.
- Will my personal information be kept private?
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 set forth in the informed consent.
- Who oversees research studies?
To help ensure that a clinical research study is ethical and that participants’ rights are protected, Institutional Review Boards (IRB) or Ethics Committees (EC) review and approve study protocols.
Want to learn more?
Call (844) 901-0101 (M-F 8am–8pm ET) or text MOM1 to 87888 to see if you pre-qualify.
If you need immediate help, or you feel you may harm yourself or your baby, please dial 911 or your local emergency number. You can also use the National Suicide Prevention Lifeline 1-800-273-8255 available 24 hours a day.
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© 2016 SAGE Therapeutics
- National Institute of Mental Health. Postpartum Depression Facts. http://www.nimh.nih.gov/health/publications/postpartum-depression-facts/index.shtml. Accessed September 28, 2016.
- Gavin NI, Gaynes BN, Lohr KN, Meltzer-Brody S, Gartlehner G, Swinson T. Perinatal depression: a systematic review of prevalence and incidence. Obstet Gynecol. 2005;106:1071-83.
- Altshuler LL, Cohen LS, Moline ML et al. Treatment of depression in women: a summary of the expert consensus guidelines. J Psychiatr Pract. 2001;7(3):185-208.