NBI-1065845-MDD3025: Study to Assess the Efficacy and Safety 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
NCT06911112
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
    NBI-1065845 tablets
  • Placebo — DRUG
    Matching placebo tablets

Study Details

The study will evaluate the efficacy of NBI-1065845 compared with placebo as an adjunctive treatment in participants with MDD on improving symptoms of depression.

Key Dates

First listed
Apr 4, 2025
Start date
Mar 31, 2025
Status verified
Aug 2026
Primary completion
Jul 31, 2027
Completion
Jul 31, 2027

Study Design

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

Arms

  • Experimental: NBI-1065845
    NBI-1065845 administered orally once a day.
  • Placebo Comparator: Placebo
    Placebo identical in appearance to NBI-1065845 will be administered orally once a day.

Primary Outcome Measure

Change from Baseline in Total Montgomery-Åsberg Depression Rating Scale (MADRS) Score at Day 56 [ Time Frame: Baseline, Day 56 ]

Central Contacts

Locations (17)

FacilityCityStateZIPSite coordinators
Neurocrine Clinical SiteHuntsvilleAlabama35801-
Neurocrine Clinical SiteBryantArkansas72022-
Neurocrine Clinical SiteGlendaleCalifornia91206-
Neurocrine Clinical SiteIrvineCalifornia92614-
Neurocrine Clinical SiteRedlandsCalifornia92373-
Neurocrine Clinical SiteSan FranciscoCalifornia94107-
Neurocrine Clinical SiteHollywoodFlorida33024-
Neurocrine Clinical SiteMiamiFlorida33174-
Neurocrine Clinical SiteTampaFlorida33634-
Neurocrine Clinical SiteAtlantaGeorgia30318-
Neurocrine Clinical SiteBostonMassachusetts02131-
Neurocrine Clinical SiteSaint CharlesMissouri63304-
Neurocrine Clinical SiteNew YorkNew York10029-
Neurocrine Clinical SiteThe BronxNew York10461-
Neurocrine Clinical SiteMasonOhio45040-
Neurocrine Clinical SiteDeSotoTexas75115-
Neurocrine Clinical SiteCharlottesvilleVirginia22903-

Find similar trials in Huntsville, AL

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By condition
Depression
By specialty
PsychiatryMental healthBehavioral health
By research site
Neurocrine Clinical Site· Huntsville, ALNeurocrine Clinical Site· Bryant, ARNeurocrine Clinical Site· Glendale, CANeurocrine Clinical Site· Irvine, CANeurocrine Clinical Site· Redlands, CANeurocrine Clinical Site· San Francisco, CA

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