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

DuKang Pharmaceuticals, Inc.

Status and phase: Enrolling; Phase 2

Conditions: Depression, Postpartum; Post-partum Depression; Postpartum Depression; Post-Natal Depression; Postnatal Depression

Treatments: Drug: Placebo; Drug: NORA520 Dose 2; Drug: NORA520 Dose 1

Study type: Interventional

Funder types: Industry

Identifiers

NCT06285916

NORA520-PT-US-1a

Details and patient eligibility

About

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.

Enrollment: 90 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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90 participants in 3 patient groups, including a placebo group

NORA520 Tablets Dose 1

Experimental group

Description:

NORA520 Tablets Dose 1

Treatment:

Drug: NORA520 Dose 1

NORA520 Tablets Dose 2

Experimental group

Description:

NORA520 Tablets Dose 2

Treatment:

Drug: NORA520 Dose 2

Placebo Tablets

Placebo Comparator group

Description:

Placebo Tablets

Treatment:

Drug: Placebo