FAQs

Study Specific Questions

1. Who can participate in this clinical research Study?

To participate in this study, you or a loved one must:

Be a female adult age 18-45 (inclusive)
Have been diagnosed with postpartum depression
- And have had a depressive episode beginning between the 3rd trimester and 4th week postpartum
Have had a baby within the last 9 months

There are additional criteria that are reviewed by the study team during your first appointment.

2. What will happen during my first visit to the study site?

You will meet with a study coordinator at a study site location closest to you. You will learn more about the research study and the benefits and risks of participation.

The study coordinator or study doctor will review the Informed Consent Form with you. You will have the chance to ask any questions about this form, and sign once comfortable and willing to participate in the study. Different procedures will be performed to see if you qualify for the clinical study.

3. What is the study drug, NORA520, that is being tested during these studies and how does it work?

NORA520 is an oral, immediate-release tablet, with a quick onset. It works in the body to increase a chemical that, when low, is associated with postpartum depression. NORA520 is taken for only 3 days for a total of 5 doses, taken once in the evening on day 1, and then once in the morning and once in the evening on days 2 & 3. Participants taking part in the study will be monitored closely through an inpatient stay while receiving the study medicine, and through follow-up visits thereafter.

4. What will happen during this study?

This study will include screening, study treatment, and follow-up periods. Screening for the study will occur in the 30 days prior to the study treatment period. During the screening, study doctors will ask you medical questions and conduct health tests to determine if you qualify for this study. The screening period occurs before you get assigned to your treatment group.

If you are eligible to participate, you will return to the study site for a 4-day stay for the study treatment period. During this time, you will receive the investigational drug for 5 doses over the course of 3 days, given by healthcare professionals. You will be monitored closely during this time, with tests done to monitor your body and health. After completing the treatment period, you will return to the study site for two outpatient follow-up visits, on days 8 and 30.

5. Where are study centers/sites?

The 20 study centers are located throughout the United States. Please see the study location section for details.

6. If I am taking any medication, do I need to stop before participating in the study?

You do not have to stop taking your medication unless you are advised to do so by the study center staff or your primary care physician.

7. Will I have to pay to be part of this study?

No, there will be no cost to you for the study therapy or study procedures.

8. Will I need health insurance to participate?

No, health insurance is not a requirement to participate in the study.

Questions About Clinical Research Studies

1. What is a clinical trial?

Clinical trials, also known as clinical studies or research studies are conducted by doctors and researchers to see if new medications or treatments are safe and effective before being approved for use by the general public. Participation in a clinical trial is completely confidential and will be protected just like any other medical information.

2. Why are research studies important?

Research studies are used to test new medications for safety, tolerability, and effectiveness before they are approved for use by the public.

3. Where can I learn more about research studies?

You can find out more information about clinical trials by browsing through www.clinicaltrials.gov. This is an online, government database that is managed by the National Library of Medicine. It provides information about both federally and privately supported clinical research studies.

4. What is informed consent?

All research studies require that doctors and/or researchers give interested participants complete and accurate information about the risks, benefits and activities of a research study. Interested participants will sign an Informed Consent Form prior to enrolling in the study. This form shows that a participant understands what will happen during the study and that they can leave the study at any time.