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NCT06285916 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study of Postpartum Depression and Depression, Postpartum, sponsored by DuKang Pharmaceuticals.

Completed
Registry status
Phase 2
Development phase
93
Enrollment target
18
Study locations

NCT06285916 is a Phase 2 study of Postpartum Depression and Depression, Postpartum that has completed, run by DuKang Pharmaceuticals. The registered enrollment target is 93 participants, below the 532-participant average among 38 other Postpartum Depression trials with a reported enrollment target (83% lower). The trial reports 18 study locations across 8 states.

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The verdict

NCT06285916, a Phase 2 study of Postpartum Depression and Depression, Postpartum, has completed, sponsored by DuKang Pharmaceuticals.

COMPLETED
Registry status
Phase 2
Development phase
93 participants
Enrollment target
18
Study locations

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.

Conditions Studied

Postpartum Depression Depression, Postpartum Post Partum Depression Postnatal Depression Post-Natal Depression

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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What the Registry Record Tells You About NCT06285916

The ClinicalTrials.gov registry entry for NCT06285916 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 93 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 532-participant average among 38 other Postpartum Depression trials with a reported enrollment target (83% lower). The listed sponsor is DuKang Pharmaceuticals, which has 1 total studies on file at ClinicalTrials.gov.

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.

NCT06285916 reports 18 study locations spanning 8 distinct geographic areas - top geographies include Florida, California, Georgia.

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.

What interventions are being tested in trial NCT06285916?

The interventions under investigation include: Placebo (DRUG), NORA520 Dose 1 (DRUG), NORA520 Dose 2 (DRUG).

Who is sponsoring clinical trial NCT06285916?

This trial is sponsored by DuKang Pharmaceuticals, which has 1 total clinical trials registered on ClinicalTrials.gov.

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.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.