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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Postpartum Depression; Depression, Postpartum; Postnatal Depression; Post-partum Depression; Post-Natal Depression
• Intervention / Treatment: Drug: NORA520 Dose 1; Drug: NORA520 Dose 2; Drug: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 90
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Clinical Trial Team; Phone Number: +886-2-8501-2609; Email: clinicaltrial@gerberarx.com

Study Locations

• United States
  • California
    • Canoga Park, California, United States, 91304
      • Gerbera site
  • Florida
    • Miami Gardens, Florida, United States, 33014
      • Gerbera sites
    • Orlando, Florida, United States, 32807
      • Gerbera site
    • Saint Petersburg, Florida, United States, 33607
      • Gerbera site
  • Texas
    • League City, Texas, United States, 77573
      • Gerbera site
    • Richardson, Texas, United States, 75080
      • Gerbera site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; Oral Placebo tablets for 3 days
Experimental: NORA520 Dose 1	Drug: NORA520 Dose 1; Oral NORA520 tablets Dose 1 for 3 days
Experimental: NORA520 Dose 2	Drug: NORA520 Dose 2; Oral NORA520 tablets Dose 2 for 3 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline to Day 4

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in HAM-D17 total score	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.	Baseline to Days 8 and 30
HAM-D17 response	Defined as having a 50% or greater reduction from baseline in HAM-D17 total score	Baseline to Days 4, 8, and 30
HAM-D17 remission	Defined as having a HAM-D17 total score ≤7	Baseline to Days 4, 8, and 30
Change from baseline in HAM-D17 subscale and individual item scores	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.	Baseline to Days 4, 8, and 30
Change from baseline in Clinical Global Impression - Severity (CGI-S) score	The CGI-S scale is a 7-point scale that requires the Investigator to assess how mentally ill is the patient at this time	Baseline to Days 4, 8, and 30
Clinical Global Impression - Improvement (CGI-I) scale positive response	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	Baseline to Days 4, 8, and 30
Change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) total score	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.	Baseline to Days 4, 8, and 30
Change from baseline in Hamilton Anxiety Rating Scale (HAM-A) total score	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.	Baseline to Days 4, 8, and 30
Change from baseline in Edinburgh Postnatal Depression Scale (EPDS) total score	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.	Baseline to Days 8 and 30
Number of patients who start any new antidepressant or anti-anxiety medication		After Day 8 assessments through Day 30

Collaborators and Investigators

• Sponsor: Gerbera Therapeutics, Inc.

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2024
• Primary Completion (Estimated): February 1, 2026
• Study Completion (Estimated): March 1, 2026

Study Registration Dates

• First Submitted: February 17, 2024
• First Submitted That Met QC Criteria: February 22, 2024
• First Posted (Estimated): February 29, 2024

Study Record Updates

• Last Update Posted (Estimated): February 29, 2024
• Last Update Submitted That Met QC Criteria: February 22, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Depression; Postpartum Depression; Postnatal Depression; NORA520; NuMom
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Pregnancy Complications; Puerperal Disorders; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Depression; Depressive Disorder; Depression, Postpartum
• Other Study ID Numbers: NORA520-PT-US-1a

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No