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Completed

NCT Number: NCT06285916

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 * 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.

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Key information

Conditions

Depression, Postpartum Behavior Behavioral Symptoms Depression Depressive Disorder Female Urogenital Diseases and Pregnancy Complications Mental Disorders Mood Disorders Post-Natal Depression Post-partum Depression Postnatal Depression Postpartum Depression Pregnancy Complications Puerperal Disorders Urogenital Diseases

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Pillar Clinical Research, Bentonville, Arkansas, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

NORA520 Dose 1

Drug

Oral NORA520 tablets Dose 1 for 3 days

NORA520 Dose 2

Drug

Oral NORA520 tablets Dose 2 for 3 days

Placebo

Drug

Oral Placebo tablets for 3 days

Primary outcomes

  1. Incidence, severity, and causality of AEs, SAEs, and AESIs

    Time frame: Up to Day 30

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

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

    Time frame: Baseline to Day 4

    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.

Secondary outcomes

  1. Change from baseline in HAM-D17 total score

    Time frame: Baseline to Days 8 and 30

    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.

  2. HAM-D17 response

    Time frame: Baseline to Days 4, 8, and 30

    Defined as having a 50% or greater reduction from baseline in HAM-D17 total score. The total score ranges from 0 to 52, with higher scores indicating more severe depression.

  3. HAM-D17 remission

    Time frame: Baseline to Days 4, 8, and 30

    Defined as having a HAM-D17 total score ≤7. The total score ranges from 0 to 52, with higher scores indicating more severe depression.

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

    Time frame: Baseline to Days 4, 8, and 30

    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.

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

    Time frame: Baseline to Days 4, 8, and 30

    The CGI-S scale is a 7-point scale that requires the Investigator to assess how mentally ill is the patient at this time. 1 - normal, not at all ill; 2 - borderline mentally ill; 3 - mildly ill; 4 - moderately ill; 5 - markedly ill; 6 - severely ill; or 7 - among the most extremely ill patients.

  6. Clinical Global Impression - Improvement (CGI-I) scale positive response

    Time frame: Baseline to Days 4, 8, and 30

    The CGI-I scale is a 7-point scale that requires the Investigator to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of study drug treatment. 1 - very much improved; 2 - much improved; 3 - minimally improved; 4 - no change; 5 - minimally worse; 6 - much worse; or 7 - very much worse

  7. Change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) total score

    Time frame: Baseline to Days 4, 8, and 30

    The MADRS contains 10 individual items related to the following symptoms: apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts. The total score ranges from 0 to 60, with higher scores indicating more severe depression.

  8. Change from baseline in Hamilton Anxiety Rating Scale (HAM-A) total score

    Time frame: Baseline to Days 4, 8, and 30

    The HAM-A contains 14 individual ratings related to the following symptoms: anxious mood, tension, fears, insomnia, intellectual, depressed mood, somatic (muscular), somatic (sensory), cardiovascular symptoms, respiratory symptoms, gastrointestinal symptoms, genitourinary symptoms, autonomic symptoms, and behavior at interview. The total score ranges from 0 to 56, with higher scores indicating more severe anxiety.

  9. Change from baseline in Edinburgh Postnatal Depression Scale (EPDS) total score

    Time frame: Baseline to Days 8 and 30

    The Edinburgh Postnatal Depression Scale (EPDS) is a set of 10 screening questions. The total score ranges from 0 to 30, with higher scores indicating more severe depression.

  10. Number of patients who start any new antidepressant or anti-anxiety medication

    Time frame: After Day 8 assessments through Day 30

Sponsors and collaborators

Lead sponsor

DuKang Pharmaceuticals, Inc.

Industry

Registry information

Official study title

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

Acronym: NuMom

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Feb 29, 2024
Registry last updated
Nov 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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