NBI-1065845-MDD3026: 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 Chino, California.

Sponsor
Neurocrine Biosciences
Study ID
NCT06963021
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

Start date
May 30, 2025
Status verified
Mar 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 (14)

FacilityCityStateZIPSite coordinators
Neurocrine Clinical SiteChinoCalifornia91710-
Neurocrine Clinical SiteLos AngelesCalifornia90025-
Neurocrine Clinical SiteStanfordCalifornia94305-
Neurocrine Clinical SiteAuroraColorado80045-
Neurocrine Clinical SiteCromwellConnecticut06416-
Neurocrine Clinical SiteFarmingtonConnecticut06030-
Neurocrine Clinical SiteMaitlandFlorida32751-
Neurocrine Clinical SiteMiamiFlorida33136-
Neurocrine Clinical SiteTampaFlorida33613-
Neurocrine Clinical SiteGaithersburgMaryland20877-
Neurocrine Clinical SiteCedarhurstNew York11516-
Neurocrine Clinical SiteNew YorkNew York10029-
Neurocrine Clinical SiteNew YorkNew York10128-
Neurocrine Clinical SitePhiladelphiaPennsylvania19104-

Find similar trials in Chino, CA

By condition
Depression
By specialty
PsychiatryMental healthBehavioral health
By research site
Neurocrine Clinical Site· Chino, CANeurocrine Clinical Site· Los Angeles, CANeurocrine Clinical Site· Stanford, CANeurocrine Clinical Site· Aurora, CONeurocrine Clinical Site· Cromwell, CTNeurocrine Clinical Site· Farmington, CT

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