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COMPLETED Phase 2

A Study to Assess the Efficacy, Safety, and Tolerability of Oral NORA520 in Adults With Severe Postpartum Depression

NCT06285916 · View on ClinicalTrials.gov ↗

Study Summary

The purpose of this research study is to test the study drug, NORA520, as a possible treatment for severe postpartum depression (PPD). The trial aims to determine: * How well NORA520 is tolerated and what side effects it may cause * If NORA520 reduces depressive symptoms in subjects with severe PPD * The amount of NORA520 in the blood at various times after taking the study drug; this provides information that helps determine how often NORA520 should be taken * In a subset of subjects, the amount of NORA520 in breastmilk at various times after taking it to determine if and how much NORA520 can pass into breastmilk Participate in this study will be randomly assigned to one of 3 different groups. All subjects will take the study drug for 3 days.

Interventions

  • DRUG Placebo
  • DRUG NORA520 Dose 1
  • DRUG NORA520 Dose 2

Study Locations (18)

Florida

  • MedOne Clinical Research — Miami
  • Meridian International Research, Inc. — Miami Gardens
  • Combined Research — Orlando
  • Clinical Research Center of Florida — Pompano Beach
  • GCP Research — St. Petersburg

California

  • Advanced Research Center — Anaheim
  • Alliance Research Institute — Canoga Park
  • Cenexel Clinical Research — Sherman Oaks
  • Cenexel Clinical Research — Torrance

Georgia

  • Cenexel Clinical Research — Atlanta
  • CenExel Clinical Research — Decatur
  • CenExel Clinical Research — Savannah

Texas

  • Maximos Ob/Gyn — League City
  • Pillar Clinical Researc — Richardson

Arkansas

  • Pillar Clinical Research — Bentonville

Illinois

  • Insight Hospital and Medical Center Chicago — Chicago

New York

  • Zucker Hillside Hospital — Glen Oaks

North Carolina

  • Monroe Biomedical Research — Monroe

Trial Details

FieldValue
Enrollment Target 93 participants
Start Date 2024-03-28
Est. Completion 2025-10-06
Phase Phase 2

Sponsor

DuKang Pharmaceuticals

1 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06285916

The ClinicalTrials.gov registry entry for NCT06285916 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 93 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is DuKang Pharmaceuticals, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 5 conditions, with Postpartum Depression appearing as the primary indexed condition, and to 3 interventions — of which Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT06285916 reports 18 study locations spanning 8 distinct geographic areas — top geographies include Florida, California, Georgia. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT06285916 about?

NCT06285916 is a clinical study titled "A Study to Assess the Efficacy, Safety, and Tolerability of Oral NORA520 in Adults With Severe Postpartum Depression". The purpose of this research study is to test the study drug, NORA520, as a possible treatment for severe postpartum depression (PPD). The trial aims to determine: * How well NORA520 is tolerated and what side effects it may cause * If NORA520 reduces depressive symptoms in subjects with severe PPD...

What is the current status of trial NCT06285916?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 93 participants. The study started on 2024-03-28. Estimated completion is 2025-10-06.

What conditions does trial NCT06285916 study?

This clinical trial studies the following conditions: Postpartum Depression, Depression, Postpartum, Post-partum Depression, Postnatal Depression, Post-Natal Depression. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT06285916?

The interventions under investigation include: Placebo (DRUG), NORA520 Dose 1 (DRUG), NORA520 Dose 2 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT06285916?

This trial is sponsored by DuKang Pharmaceuticals, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT06285916 being conducted?

This trial has 18 study locations across Arkansas, California, Florida, Georgia, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial