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 Little Rock, Arkansas.

Sponsor
Neurocrine Biosciences
Study ID
NCT06786624
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
Jan 22, 2025
Status verified
Oct 2025
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 (18)

FacilityCityStateZIPSite coordinators
Neurocrine Clinical SiteLittle RockArkansas72204-
Neurocrine Clinical SiteGarden GroveCalifornia92844-
Neurocrine Clinical SiteOrangeCalifornia92866-
Neurocrine Clinical SitePico RiveraCalifornia90660-
Neurocrine Clinical SiteSan DiegoCalifornia92103-
Neurocrine Clinical SiteUplandCalifornia91786-
Neurocrine Clinical SiteHollywoodFlorida33024-
Neurocrine Clinical SiteMaitlandFlorida32751-
Neurocrine Clinical SiteBostonMassachusetts02116-
Neurocrine Clinical SiteWatertownMassachusetts02472-
Neurocrine Clinical SiteMount KiscoNew York10549-
Neurocrine Clinical SiteAvon LakeOhio44012-
Neurocrine Clinical SiteWestlakeOhio44145-
Neurocrine Clinical SiteDallasTexas75251-
Neurocrine Clinical SiteHoustonTexas77030-
Neurocrine Clinical SiteRichmondTexas77407-
Neurocrine Clinical SiteThe WoodlandsTexas77381-
Neurocrine Clinical SiteEverettWashington98201-

Find similar trials in Little Rock, AR

By condition
Depression
By specialty
PsychiatryMental healthBehavioral health
By research site
Neurocrine Clinical Site· Little Rock, ARNeurocrine Clinical Site· Garden Grove, CANeurocrine Clinical Site· Orange, CANeurocrine Clinical Site· Pico Rivera, CANeurocrine Clinical Site· San Diego, CANeurocrine Clinical Site· Upland, CA

Related Studies