Long-Term Study to Assess the Safety and Tolerability of NBI-1065845 as an Adjunctive Treatment in Participants With Major Depressive Disorder (MDD)

Part of paid clinical trials in Huntsville, Alabama.

Sponsor
Neurocrine Biosciences
Study ID
NCT06966401
Phase
PHASE3
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

This study will evaluate the long-term safety and tolerability of NBI-1065845 as an adjunctive treatment in participants with MDD.

Key Dates

Start date
Apr 16, 2025
Status verified
Feb 2026
Primary completion
May 31, 2029
Completion
May 31, 2030

Study Design

Enrollment
850 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: NBI-1065845
    NBI-1065845 administered orally once a day.

Primary Outcome Measure

Number of Participants with Treatment-emergent Adverse Events (TEAEs) [ Time Frame: Baseline through Week 52 ]

Central Contacts

Locations (40)

FacilityCityStateZIPSite coordinators
Neurocrine Clinical SiteHuntsvilleAlabama35801-
Neurocrine Clinical SiteBryantArkansas72022-
Neurocrine Clinical SiteLittle RockArkansas72204-
Neurocrine Clinical SiteGlendaleCalifornia91206-
Neurocrine Clinical SiteLos AngelesCalifornia90025-
Neurocrine Clinical SiteOceansideCalifornia92056-
Neurocrine Clinical SiteOrangeCalifornia92866-
Neurocrine Clinical SitePico RiveraCalifornia90660-
Neurocrine Clinical SiteSan DiegoCalifornia92103-8229-
Neurocrine Clinical SiteUplandCalifornia91786-
Neurocrine Clinical SiteCromwellConnecticut06416-
Neurocrine Clinical SiteFarmingtonConnecticut06030-
Neurocrine Clinical SiteHollywoodFlorida33024-
Neurocrine Clinical SiteMaitlandFlorida32751-5669-
Neurocrine Clinical SiteMaitlandFlorida32751-
Neurocrine Clinical SiteMiamiFlorida33174-
Neurocrine Clinical SiteMiami GardensFlorida33014-
Neurocrine Clinical SitePalm BayFlorida32905-
Neurocrine Clinical SiteTampaFlorida33607-
Neurocrine Clinical SiteTampaFlorida33629-
Neurocrine Clinical SiteAtlantaGeorgia30318-
Neurocrine Clinical SiteGaithersburgMaryland20877-
Neurocrine Clinical SiteBostonMassachusetts02116-
Neurocrine Clinical SiteWatertownMassachusetts02472-
Neurocrine Clinical SiteO'FallonMissouri63368-
Neurocrine Clinical SiteSaint CharlesMissouri63304-
Neurocrine Clinical SiteCedarhurstNew York11516-
Neurocrine Clinical SiteMount KiscoNew York10549-
Neurocrine Clinical SiteNew YorkNew York10029-
Neurocrine Clinical SiteNew YorkNew York10128-
Neurocrine Clinical SiteThe BronxNew York10461-
Neurocrine Clinical SiteAvon LakeOhio44012-
Neurocrine Clinical SiteEdmondOklahoma73013-
Neurocrine Clinical SitePhiladelphiaPennsylvania19104-
Neurocrine Clinical SiteDallasTexas75251-
Neurocrine Clinical SiteHoustonTexas77030-
Neurocrine Clinical SiteRichmondTexas77407-
Neurocrine Clinical SiteStaffordTexas77477-
Neurocrine Clinical SiteThe WoodlandsTexas77381-
Neurocrine Clinical SiteEverettWashington98201-

Find similar trials in Huntsville, AL

By condition
Depression
By specialty
PsychiatryMental healthBehavioral health
By research site
Neurocrine Clinical Site· Huntsville, ALNeurocrine Clinical Site· Bryant, ARNeurocrine Clinical Site· Little Rock, ARNeurocrine Clinical Site· Glendale, CANeurocrine Clinical Site· Los Angeles, CANeurocrine Clinical Site· Oceanside, CA

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