A Study to Assess the Efficacy, Safety, and Tolerability of Oral NORA520 in Adults With Severe Postpartum Depression
NCT ID: NCT06285916
Last Updated: 2025-11-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
93 participants
INTERVENTIONAL
2024-03-28
2025-10-06
Brief Summary
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* 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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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NORA520 Tablets Dose 1
NORA520 Tablets Dose 1
NORA520 Dose 1
Oral NORA520 tablets Dose 1 for 3 days
NORA520 Tablets Dose 2
NORA520 Tablets Dose 2
NORA520 Dose 2
Oral NORA520 tablets Dose 2 for 3 days
Placebo Tablets
Placebo Tablets
Placebo
Oral Placebo tablets for 3 days
Interventions
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NORA520 Dose 1
Oral NORA520 tablets Dose 1 for 3 days
NORA520 Dose 2
Oral NORA520 tablets Dose 2 for 3 days
Placebo
Oral Placebo tablets for 3 days
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
18 Years
45 Years
FEMALE
No
Sponsors
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DuKang Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
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Locations
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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
Cenexel Clinical Research
Atlanta, Georgia, United States
CenExel Clinical Research
Decatur, Georgia, United States
CenExel Clinical Research
Savannah, Georgia, United States
Insight Hospital and Medical Center Chicago
Chicago, Illinois, United States
Zucker Hillside Hospital
Glen Oaks, New York, United States
Monroe Biomedical Research
Monroe, North Carolina, United States
Maximos Ob/Gyn
League City, Texas, United States
Pillar Clinical Researc
Richardson, Texas, United States
Countries
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Other Identifiers
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NORA520-PT-US-1a
Identifier Type: -
Identifier Source: org_study_id
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