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

DuKang Pharmaceuticals, Inc.93 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Depression, Postpartum Postpartum Depression Post-partum Depression Postnatal Depression

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 45 Years

Medical Language ↔ Plain English

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.

Locations (18)

Pillar Clinical Research

Bentonville, Arkansas, United States

Advanced Research Center

Anaheim, California, United States

Alliance Research Institute

Canoga Park, California, United States

Cenexel Clinical Research

Sherman Oaks, California, United States

Cenexel Clinical Research

Torrance, California, United States

MedOne Clinical Research

Miami, Florida, United States

Meridian International Research, Inc.

Miami Gardens, Florida, United States

Combined Research

Orlando, Florida, United States

Clinical Research Center of Florida

Pompano Beach, Florida, United States

GCP Research

St. Petersburg, Florida, United States

...and 8 more locations

Outcomes

Primary Outcomes

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

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

Time frame: 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.

Time frame: Baseline to Day 4

Secondary Outcomes

Change from baseline in HAM-D17 total score

Time frame: Baseline to Days 8 and 30

HAM-D17 response

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.