protocolSection identificationModule nctId: NCT06267846, orgStudyIdInfo id: NBI-1070770-MDD2029, briefTitle: A Study to Evaluate the Efficacy and Safety of NBI-1070770 in Adults With Major Depressive Disorder, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-20, primaryCompletionDateStruct date: 2025-09, completionDateStruct date: 2025-12, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: Neurocrine Biosciences, class: INDUSTRY, descriptionModule briefSummary: To evaluate the efficacy, safety, and tolerability of NBI-1070770 compared to placebo on improving symptoms of depression in participants with major depressive disorder (MDD)., conditionsModule conditions: Major Depressive Disorder, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, enrollmentInfo count: 72, type: ESTIMATED, armsInterventionsModule interventions name: NBI-1070770, interventions name: Placebo, outcomesModule primaryOutcomes measure: Change in Total Montgomery-Åsberg Depression Rating Scale (MADRS) Score from Baseline to Day 5, secondaryOutcomes measure: Change in Total MADRS Score from Baseline at Postbaseline Timepoints, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Neurocrine Clinical Site, status: RECRUITING, city: Little Rock, state: Arkansas, zip: 72211, country: United States, geoPoint lat: 34.74648, lon: -92.28959, locations facility: Neurocrine Clinical Site, status: RECRUITING, city: Rogers, state: Arkansas, zip: 72758, country: United States, geoPoint lat: 36.33202, lon: -94.11854, locations facility: Neurocrine Clinical Site, status: RECRUITING, city: Lemon Grove, state: California, zip: 91945, country: United States, geoPoint lat: 32.74255, lon: -117.03142, locations facility: Neurocrine Clinical Site, status: RECRUITING, city: Long Beach, state: California, zip: 90806, country: United States, geoPoint lat: 33.76696, lon: -118.18923, locations facility: Neurocrine Clinical Site, status: RECRUITING, city: Hollywood, state: Florida, zip: 33024, country: United States, geoPoint lat: 26.0112, lon: -80.14949, locations facility: Neurocrine Clinical Site, status: RECRUITING, city: Decatur, state: Georgia, zip: 30030, country: United States, geoPoint lat: 33.77483, lon: -84.29631, locations facility: Neurocrine Clinical Site, status: RECRUITING, city: Savannah, state: Georgia, zip: 31405, country: United States, geoPoint lat: 32.08354, lon: -81.09983, locations facility: Neurocrine Clinical Site, status: RECRUITING, city: Gaithersburg, state: Maryland, zip: 20877, country: United States, geoPoint lat: 39.14344, lon: -77.20137, locations facility: Neurocrine Clinical Site, status: RECRUITING, city: North Canton, state: Ohio, zip: 44730, country: United States, geoPoint lat: 40.87589, lon: -81.40234, locations facility: Neurocrine Clinical Site, status: RECRUITING, city: Houston, state: Texas, zip: 77008, country: United States, geoPoint lat: 29.76328, lon: -95.36327, hasResults: False