protocolSection identificationModule nctId: NCT06285916, orgStudyIdInfo id: NORA520-PT-US-1a, briefTitle: A Study to Assess the Efficacy, Safety, and Tolerability of Oral NORA520 in Adults With Severe Postpartum Depression, acronym: NuMom, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-02, primaryCompletionDateStruct date: 2026-02, completionDateStruct date: 2026-03, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-02-29, sponsorCollaboratorsModule leadSponsor name: Gerbera Therapeutics, Inc., class: INDUSTRY, descriptionModule briefSummary: 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., conditionsModule conditions: Depression, Postpartum, conditions: Postpartum Depression, conditions: Post-partum Depression, conditions: Postnatal Depression, conditions: Post-Natal Depression, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 90, type: ESTIMATED, armsInterventionsModule interventions name: NORA520 Dose 1, interventions name: NORA520 Dose 2, interventions name: Placebo, outcomesModule primaryOutcomes measure: Incidence, severity, and causality of AEs, SAEs, and AESIs, primaryOutcomes measure: Change from baseline in HAM-D17 total score compared to placebo, secondaryOutcomes measure: Change from baseline in HAM-D17 total score, secondaryOutcomes measure: HAM-D17 response, secondaryOutcomes measure: HAM-D17 remission, secondaryOutcomes measure: Change from baseline in HAM-D17 subscale and individual item scores, secondaryOutcomes measure: Change from baseline in Clinical Global Impression - Severity (CGI-S) score, secondaryOutcomes measure: Clinical Global Impression - Improvement (CGI-I) scale positive response, secondaryOutcomes measure: Change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) total score, secondaryOutcomes measure: Change from baseline in Hamilton Anxiety Rating Scale (HAM-A) total score, secondaryOutcomes measure: Change from baseline in Edinburgh Postnatal Depression Scale (EPDS) total score, secondaryOutcomes measure: Number of patients who start any new antidepressant or anti-anxiety medication, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 45 Years, stdAges: ADULT, contactsLocationsModule locations facility: Gerbera site, city: Canoga Park, state: California, zip: 91304, country: United States, geoPoint lat: 34.20112, lon: -118.59814, locations facility: Gerbera sites, city: Miami Gardens, state: Florida, zip: 33014, country: United States, geoPoint lat: 25.94298, lon: -80.24452, locations facility: Gerbera site, city: Orlando, state: Florida, zip: 32807, country: United States, geoPoint lat: 28.53834, lon: -81.37924, locations facility: Gerbera site, city: Saint Petersburg, state: Florida, zip: 33607, country: United States, geoPoint lat: 27.77086, lon: -82.67927, locations facility: Gerbera site, city: League City, state: Texas, zip: 77573, country: United States, geoPoint lat: 29.50745, lon: -95.09493, locations facility: Gerbera site, city: Richardson, state: Texas, zip: 75080, country: United States, geoPoint lat: 32.94818, lon: -96.72972, hasResults: False