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Testing NORA520 for severe postpartum depression in adults

A Randomized, Placebo-Controlled, Double-Blinded, Phase 2 Study to Evaluate the Efficacy, Safety, and Tolerability of Oral NORA520 in Female Adults With Severe Postpartum Depression

Phase 2 Interventional DuKang Pharmaceuticals, Inc. · NCT06285916

This study is testing a new medication called NORA520 to see if it can help adults with severe postpartum depression feel better.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment90 (estimated)
Ages18 Years to 45 Years
SexFemale
SponsorDuKang Pharmaceuticals, Inc. Industry-sponsored
Locations18 sites (Bentonville, Arkansas and 17 other locations)
Trial IDNCT06285916 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the efficacy, safety, and tolerability of the oral medication NORA520 in adults suffering from severe postpartum depression. Participants will be randomly assigned to receive either NORA520 at two different doses or a placebo for a duration of three days. The study aims to assess how well the drug is tolerated, its effects on depressive symptoms, and the pharmacokinetics of NORA520, including its presence in breastmilk. The trial includes adult females aged 18 to 45 who are within nine months postpartum and have experienced a depressive episode related to childbirth.

Who should consider this trial

Good fit: Ideal candidates are adult females aged 18 to 45 who are within nine months postpartum and have experienced a depressive episode following childbirth.

Not a fit: Patients with a history of bipolar disorder, schizophrenia, or those who have failed multiple antidepressant treatments may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new option for women suffering from severe postpartum depression.

How similar studies have performed: While this approach is novel in its specific application to postpartum depression, similar studies evaluating new treatments for depression have shown promise.

Eligibility criteria

Show full inclusion / exclusion criteria 
Key Inclusion Criteria:

* Are willing and able to provide signed informed consent to participate in the study and to comply with all study procedures and scheduled visits
* Are an adult female between 18 and 45 years of age, inclusive;
* Have either ceased lactating at Screening, or if still lactating or actively breastfeeding at Screening, agree to temporarily cease giving breastmilk to their infant(s) from just prior to first dose of study drug on Day 1 through Day 14;
* Have a negative pregnancy test at Screening and Day 1 (prior to dosing);
* Have had a depressive episode that began no earlier than the third trimester and no later than the first 4 weeks following delivery
* Are ≤9 months postpartum at Screening.

Key Exclusion Criteria:

* Have a history or current diagnosis or current treatment of bipolar disorder, schizophrenia, or schizoaffective disorder;
* Have had recorded treatment failure of ≥2 different antidepressant classes (e.g., SSRI, SNRI) in the current or previous episode;
* Are currently experiencing active psychosis per Investigator assessment, or are taking typical or atypical antipsychotic medication;
* Have a history of suicidal behavior within 2 years;
* Have a history or current diagnosis of sleep apnea or narcolepsy.

Where this trial is running

Bentonville, Arkansas and 17 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Depression, PostpartumPostpartum DepressionPost-partum DepressionPostnatal DepressionPost-Natal DepressionDepressionNORA520NuMom
Last reviewed 2026-06-09 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.