Clinical trial NCT06285916: A Study to Assess the Efficacy, Safety, and Tolerability of Oral NORA520 in Adults With Severe Postpartum Depression
Official 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Depression, Postpartum
Postpartum Depression
Post-partum Depression
Postnatal Depression
Post-Natal Depression
Keywords: Depression
Postpartum Depression
NORA520
Postnatal Depression
NuMom
Lead sponsor: DuKang Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2024-02-29
Enrollment: 90
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Incidence, severity, and causality of AEs, SAEs, and AESIs
timeFrame: Up to Day 30
measure: Change from baseline in HAM-D17 total score compared to placebo
timeFrame: Baseline to Day 4
Secondary outcomes:
measure: Change from baseline in HAM-D17 total score
timeFrame: Baseline to Days 8 and 30
measure: HAM-D17 response
timeFrame: Baseline to Days 4, 8, and 30
measure: HAM-D17 remission
timeFrame: Baseline to Days 4, 8, and 30
measure: Change from baseline in HAM-D17 subscale and individual item scores
timeFrame: Baseline to Days 4, 8, and 30
measure: Change from baseline in Clinical Global Impression - Severity (CGI-S) score
timeFrame: Baseline to Days 4, 8, and 30
measure: Clinical Global Impression - Improvement (CGI-I) scale positive response
timeFrame: Baseline to Days 4, 8, and 30
measure: Change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) total score
timeFrame: Baseline to Days 4, 8, and 30
measure: Change from baseline in Hamilton Anxiety Rating Scale (HAM-A) total score
timeFrame: Baseline to Days 4, 8, and 30
measure: Change from baseline in Edinburgh Postnatal Depression Scale (EPDS) total score
timeFrame: Baseline to Days 8 and 30
measure: Number of patients who start any new antidepressant or anti-anxiety medication
timeFrame: After Day 8 assessments through Day 30
Other outcomes:
Locations:
city: Bentonville
country: United States
facility: Pillar Clinical Research
state: Arkansas
city: Anaheim
country: United States
facility: Advanced Research Center
state: California
city: Canoga Park
country: United States
facility: Alliance Research Institute
state: California
city: Sherman Oaks
country: United States
facility: Cenexel Clinical Research
state: California
city: Torrance
country: United States
facility: Cenexel Clinical Research
state: California
city: Miami Gardens
country: United States
facility: Meridian International Research, Inc.
state: Florida
city: Miami
country: United States
facility: MedOne Clinical Research
state: Florida
city: Orlando
country: United States
facility: Combined Research
state: Florida
city: Pompano Beach
country: United States
facility: Clinical Research Center of Florida
state: Florida
city: Saint Petersburg
country: United States
facility: GCP Research
state: Florida
city: Atlanta
country: United States
facility: Cenexel Clinical Research
state: Georgia
city: Decatur
country: United States
facility: CenExel Clinical Research
state: Georgia
city: Savannah
country: United States
facility: CenExel Clinical Research
state: Georgia
city: Chicago
country: United States
facility: Insight Hospital and Medical Center Chicago
state: Illinois
city: Glen Oaks
country: United States
facility: Zucker Hillside Hospital
state: New York
city: Monroe
country: United States
facility: Monroe Biomedical Research
state: North Carolina
city: League City
country: United States
facility: Maximos Ob/Gyn
state: Texas
city: Richardson
country: United States
facility: Pillar Clinical Researc
state: Texas
Study officials:
References: