Postpartum Depression Study

About The NORA520 Postpartum Depression Study

The NORA520 research study is evaluating whether NORA520, an investigational medication, is safe and effective in improving symptoms of severe postpartum depression in women. NORA520 will be compared to placebo, a pill with no expected benefits.

The study will last up to 30 days, including screening, study treatment, and follow-up periods.

Participants who successfully enroll into the study will be randomly assigned to receive either NORA520, or placebo. The placebo pill looks like the NORA520 tablet, although it does not contain any active ingredient and is not expected to provide any benefit. All investigational medication will be provided to participants by healthcare professionals, and will be monitored through inpatient stays for the entirety of the course of treatment.

What is the medication for this study?

The medication that we are investigating , NORA520,   is an immediate-release, fast-acting tablet taken by mouth. It is taken for only 3 consecutive days, for a total of 5 doses; once in the evening on day one, and then once in the morning and once in the evening on days two and three. NORA520 is a pro-drug of brexanolone, which means it turns into brexanolone in your body.  

Brexanolone is a hormone that naturally occurs in the body during pregnancy and was previously FDA approved to treat postpartum depression (under the name Zulresso), but it could only be given as an infusion under medical supervision, and costs up to $35,000 for a single treatment. This study is investigating a version of the medication that can be taken by mouth as a pill, which could lead to a more affordable and accessible treatment for postpartum depression.

Who can participate?

This study is open to women ages 18-45 who meet the following conditions:

• Gave birth in the last 9 months

• Have moderate to severe symptoms of depression that began shortly after giving birth

• No history of bipolar disorder, schizophrenia, borderline personality disorder, or suicide attempts in the last 2 years

• Able to pass a drug test for marijuana, cocaine, amphetamines, PCP, and opioids

• Able to complete a 4-day inpatient stay at our office in Pompano Beach, FL

What happens during the study?

• Screening visit: During the initial screening, patients will have a psychological exam, physical exam, and lab work, which will determine if they are eligible to continue

• Inpatient visit, days 1-4: Patients will receive either the active medication or placebo, and will have blood samples taken throughout the day, as well as psychological exams so that we can measure the effect of the medication.

• Follow-up visits, days 8 and 30: Repeat of mental health assessments and lab tests

What are the benefits and compensation?

Participants will receive study-related care at no cost, including, psychological testing, lab work, and a physical exam from a licenced physician. Participants have a 66% chance of receiving the study medication. Additionally, we can provide transportation, and compensation of $2,190 for you participation.

The payment schedule is as follows:

• Screening visit: $130

• 3-night inpatient visit: $1,800

• Day 8 visit: $130

• Day 30 visit: $130

• Total: $2,190

References:

Azhar Y, Din AU. Brexanolone. [Updated 2023 Jun 12]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK541054/

Deligiannidis KM, Vaughn R. Staying up to date with evolving postpartum depression pathophysiology and treatment research. J Clin Psychiatry. 2023;84(4):sagppd3003sho.