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

NCT06285916 | Completed Phase 2 FDA Drug

• 1 other identifier: NORA520-PT-US-1a
• Study Type: interventional
• Target: 93
• Locations: 1 country
• Sites: 18

Brief 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

Depression, Postpartum; Post-partum Depression; Post-Natal Depression

Keywords

Depression; Postpartum Depression; NORA520; Postnatal Depression; NuMom

Outcome Measures

Primary Outcomes (2)

• Incidence, severity, and causality of AEs, SAEs, and AESIs

  Adverse events (AEs), Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs)

  Up to Day 30

• Change from baseline in HAM-D17 total score compared to placebo

  The Seventeen-Item Hamilton Rating Scale for Depression (HAM-D17) contains 17 individual ratings related to the following symptoms: depressed mood, feelings of guilt, suicide, insomnia (initial, middle, and late), work and interests, psychomotor retardation, psychomotor agitation, anxiety (psychic and somatic), gastrointestinal symptoms, general somatic symptoms, sexual interest, hypochondriasis, insight, and weight loss. The total score ranges from 0 to 52, with higher scores indicating more severe depression.

  Baseline to Day 4

Secondary Outcomes (10)

• Change from baseline in HAM-D17 total score

  Baseline to Days 8 and 30

• HAM-D17 response

  Baseline to Days 4, 8, and 30

• HAM-D17 remission

  Baseline to Days 4, 8, and 30

• Change from baseline in HAM-D17 subscale and individual item scores

  Baseline to Days 4, 8, and 30

• Change from baseline in Clinical Global Impression - Severity (CGI-S) score

  Baseline to Days 4, 8, and 30

Study Arms (3)

NORA520 Tablets Dose 1

EXPERIMENTAL

NORA520 Tablets Dose 1

Drug: NORA520 Dose 1

NORA520 Tablets Dose 2

EXPERIMENTAL

NORA520 Tablets Dose 2

Drug: NORA520 Dose 2

Placebo Tablets

PLACEBO COMPARATOR

Placebo Tablets

Drug: Placebo

Interventions

NORA520 Dose 1 DRUG

Oral NORA520 tablets Dose 1 for 3 days

NORA520 Tablets Dose 1

NORA520 Dose 2 DRUG

Oral NORA520 tablets Dose 2 for 3 days

NORA520 Tablets Dose 2

Placebo DRUG

Oral Placebo tablets for 3 days

Placebo Tablets

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• DuKang Pharmaceuticals, Inc.: lead

Study Sites (18)

Pillar Clinical Research

Bentonville, Arkansas, 72712, United States

Location

Advanced Research Center

Anaheim, California, 92805, United States

Location

Alliance Research Institute

Canoga Park, California, 91304, United States

Location

Cenexel Clinical Research

Sherman Oaks, California, 91403, United States

Location

Cenexel Clinical Research

Torrance, California, 90504, United States

Location

MedOne Clinical Research

Miami, Florida, 33145, United States

Location

Meridian International Research, Inc.

Miami Gardens, Florida, 33014, United States

Location

Combined Research

Orlando, Florida, 32807, United States

Location

Clinical Research Center of Florida

Pompano Beach, Florida, 33060, United States

Location

GCP Research

St. Petersburg, Florida, 33607, United States

Location

Cenexel Clinical Research

Atlanta, Georgia, 30331, United States

Location

CenExel Clinical Research

Decatur, Georgia, 30030, United States

Location

CenExel Clinical Research

Savannah, Georgia, 31405, United States

Location

Insight Hospital and Medical Center Chicago

Chicago, Illinois, 60616, United States

Location

Zucker Hillside Hospital

Glen Oaks, New York, 11004, United States

Location

Monroe Biomedical Research

Monroe, North Carolina, 28112, United States

Location

Maximos Ob/Gyn

League City, Texas, 77573, United States

Location

Pillar Clinical Researc

Richardson, Texas, 75080, United States

Location

MeSH Terms

Conditions

Depression, Postpartum; Depression

Condition Hierarchy (Ancestors)

Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Depressive Disorder; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2024
• First Posted: February 29, 2024
• Study Start: March 28, 2024
• Primary Completion: September 11, 2025
• Study Completion: October 6, 2025
• Last Updated: November 20, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (18)