A Study to Evaluate the Maintenance Effect of NBI-1065845 as an Adjunctive Treatment in Participants With Major Depressive Disorder (MDD)

Part of paid clinical trials in Oceanside, California.

Sponsor
Neurocrine Biosciences
Study ID
NCT07196501
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

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

Interventions

  • NBI-1065845 — DRUG
    Oral tablet
  • Placebo — DRUG
    Oral tablet

Study Details

The primary objective of this study is to evaluate the efficacy of NBI-1065845 compared with placebo as an adjunctive treatment in delaying relapse of depressive symptoms (maintenance of effect) in participants with MDD.

Key Dates

Start date
Aug 18, 2025
Status verified
Jan 2026
Primary completion
Jul 31, 2028
Completion
Jul 31, 2028

Study Design

Enrollment
550 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Open-label Treatment Period: NBI-1065845
    Participants will be treated with NBI-1065845 during the open-label treatment period.
  • Experimental: Randomized Double-blind Maintenance Period: NBI-1065845
    Participants will be randomized to receive NBI-1065845 during the randomized double-blind maintenance period.
  • Experimental: Randomized Double-blind Maintenance Period: Placebo
    Participants will be randomized to receive matching placebo during the randomized double-blind maintenance period.

Primary Outcome Measure

Time from Randomization to Relapse [ Time Frame: From randomization to the earliest of relapse or end-of study (up to approximately 32 months) ]

Central Contacts

Locations (18)

FacilityCityStateZIPSite coordinators
Neurocrine Clinical SiteOceansideCalifornia92056-
Neurocrine Clinical SiteSan JoseCalifornia95124-
Neurocrine Clinical SiteNew HavenConnecticut06520-
Neurocrine Clinical SiteMiami GardensFlorida33014-
Neurocrine Clinical SiteOrlandoFlorida32803-
Neurocrine Clinical SitePalm BayFlorida32905-
Neurocrine Clinical SiteTampaFlorida33629-
Neurocrine Clinical SiteMarreroLouisiana70072-
Neurocrine Clinical SiteO'FallonMissouri63368-
Neurocrine Clinical SiteAlbuquerqueNew Mexico87109-
Neurocrine Clinical SiteCharlotteNorth Carolina28211-
Neurocrine Clinical SiteEdmondOklahoma73013-
Neurocrine Clinical SiteOklahoma CityOklahoma73112-
Neurocrine Clinical SiteBellaireTexas77401-
Neurocrine Clinical SiteFriendswoodTexas77546-
Neurocrine Clinical SiteStaffordTexas77477-
Neurocrine Clinical SiteWichita FallsTexas76309-
Neurocrine Clinical SiteDraperUtah84020-

Find similar trials in Oceanside, CA

By condition
Depression
By specialty
PsychiatryMental healthBehavioral health
By research site
Neurocrine Clinical Site· Oceanside, CANeurocrine Clinical Site· San Jose, CANeurocrine Clinical Site· New Haven, CTNeurocrine Clinical Site· Miami Gardens, FLNeurocrine Clinical Site· Orlando, FLNeurocrine Clinical Site· Palm Bay, FL

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