Skylark Study

Now Enrolling: This research study is evaluating the efficacy and safety of an investigational oral medication in women with severe postpartum depression

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.

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The information you provide will be kept confidential.

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:

  1. Meet with the study doctor and staff
  2. Review additional information
  3. Have an initial evaluation
  4. 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.

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The information you provide will be kept confidential.

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
See If You May Qualify ›

The information you provide will be kept confidential.

Frequently Asked Questions

This section will help answer some of the important questions you may have.

Want to learn more?

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The information you provide will be kept confidential.