90 Participants Needed

NORA520 for Postpartum Depression

(NuMom Trial)

Recruiting at 37 trial locations
CT
Overseen ByClinical Trial Team
Age: 18 - 65
Sex: Female
Trial Phase: Phase 2
Sponsor: DuKang Pharmaceuticals, Inc.
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial is testing a drug called NORA520 to see if it can help women with severe postpartum depression. The study will check how well the drug works, its side effects, and how much of it gets into the blood and breastmilk. Women in the study will take the drug for a short period.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you are taking antipsychotic medications, you may not be eligible to participate.

Is NORA520 (Allopregnanolone prodrug) safe for humans?

Brexanolone, an intravenous form of allopregnanolone, has been tested in several studies for postpartum depression and is generally considered safe when administered under medical supervision, with monitoring during the 60-hour infusion.12345

How is the drug NORA520 different from other treatments for postpartum depression?

NORA520 is unique because it is an allopregnanolone prodrug, similar to brexanolone, which is the first FDA-approved drug specifically for postpartum depression. Unlike traditional antidepressants, it works by modulating GABA-A receptors, potentially offering rapid relief from symptoms.23567

What data supports the effectiveness of the drug NORA520 for postpartum depression?

Research on brexanolone, a drug similar to NORA520, shows it is effective in treating postpartum depression by stabilizing hormone levels and reducing depression symptoms. Brexanolone, which is an allopregnanolone formulation like NORA520, has been shown to significantly reduce depression scores in clinical trials.23456

Are You a Good Fit for This Trial?

This trial is for adults with severe postpartum depression. Participants will be randomly assigned to one of three groups and will take the study drug or placebo for 3 days.

Inclusion Criteria

Negative pregnancy test at Screening and Day 1 (prior to dosing)
Willing and able to provide signed informed consent to participate in the study and to comply with all study procedures and scheduled visits
I gave birth less than 9 months ago.
See 3 more

Exclusion Criteria

I have been diagnosed with sleep apnea or narcolepsy.
History of suicidal behavior within 2 years
I am not currently experiencing psychosis nor taking antipsychotic medication.
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the study drug, NORA520, for 3 days to assess its efficacy, safety, and tolerability in treating severe postpartum depression

3 days

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments at Days 4, 8, and 30

4 weeks
3 visits (in-person or virtual)

What Are the Treatments Tested in This Trial?

Interventions

  • NORA520
Trial Overview The study tests NORA520's effectiveness in reducing depressive symptoms, its safety, tolerability, how it's processed by the body, and if it transfers into breastmilk. There are two different doses of NORA520 being compared against a placebo.
How Is the Trial Designed?
3Treatment groups
Experimental Treatment
Placebo Group
Group I: NORA520 Tablets Dose 2Experimental Treatment1 Intervention
Group II: NORA520 Tablets Dose 1Experimental Treatment1 Intervention
Group III: Placebo TabletsPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

DuKang Pharmaceuticals, Inc.

Lead Sponsor

Gerbera Therapeutics, Inc.

Lead Sponsor

Trials
1
Recruited
90+

Published Research Related to This Trial

Brexanolone is the first FDA-approved medication specifically for postpartum depression, utilizing allopregnanolone to stabilize hormone levels that drop after childbirth, which may contribute to the condition.
Administered as a continuous intravenous infusion over 60 hours, brexanolone works by modulating neuronal excitability, showing promising efficacy and tolerability in clinical trials for treating postpartum depression.
Intravenous brexanolone for postpartum depression: what it is, how well does it work, and will it be used?Faden, J., Citrome, L.[2020]
Brexanolone is the first FDA-approved medication specifically for postpartum depression (PPD), showing significant efficacy in reducing depression scores in three randomized controlled trials with intravenous administration over 60 hours.
All studies demonstrated a statistically significant reduction in the Hamilton Rating Scale for Depression (HAM-D) scores compared to placebo, indicating brexanolone's effectiveness in treating moderate-to-severe PPD.
Treating Postpartum Depression: What Do We Know about Brexanolone?Ali, M., Aamir, A., Diwan, MN., et al.[2021]
Brexanolone infusion significantly reduces inflammatory markers such as TNF-α and IL-6 in postpartum depression patients, which correlates with improvements in depression scores, indicating its efficacy in treating PPD.
The treatment appears to work by inhibiting inflammatory responses to specific immune activators, suggesting that inflammation may play a role in postpartum depression and that targeting these pathways can enhance recovery.
Brexanolone therapeutics in post-partum depression involves inhibition of systemic inflammatory pathways.Balan, I., Patterson, R., Boero, G., et al.[2023]

Citations

Intravenous brexanolone for postpartum depression: what it is, how well does it work, and will it be used? [2020]
Treating Postpartum Depression: What Do We Know about Brexanolone? [2021]
Brexanolone therapeutics in post-partum depression involves inhibition of systemic inflammatory pathways. [2023]
Neuroendocrine insights into neurosteroid therapy for postpartum depression. [2023]
Brexanolone for postpartum depression: A meta-analysis of randomized controlled studies. [2020]
Open-label, proof-of-concept study of brexanolone in the treatment of severe postpartum depression. [2021]
Allopregnanolone Concentrations in Breast Milk and Plasma from Healthy Volunteers Receiving Brexanolone Injection, With Population Pharmacokinetic Modeling of Potential Relative Infant Dose. [2022]
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