Study to Assess the Efficacy and Safety of NBI-1065845 in Adults With Major Depressive Disorder (MDD)

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Neurocrine Biosciences
Study ID
NCT05203341
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Placebo — DRUG
    Matching placebo tablets
  • NBI-1065845 — DRUG
    NBI-1065845 tablets

Study Details

The purpose of this study is to evaluate the efficacy of NBI-1065845 compared with placebo in participants with MDD on improving symptoms of depression.

Key Dates

Start date
Feb 21, 2022
Status verified
Jan 2025
Primary completion
Jan 10, 2024
Completion
Feb 21, 2024

Study Design

Enrollment
183 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Placebo Comparator: Placebo
    Participants will receive placebo orally once a day.
  • Experimental: NBI-1065845 Low Dose
    Participants will receive low-dose NBI-1065845 orally once a day.
  • Experimental: NBI-1065845 High Dose
    Participants will receive high-dose NBI-1065845 orally once a day.

Primary Outcome Measure

Change from Baseline in Total Montgomery Åsberg Depression Rating Scale (MADRS) Score at Day 28 [ Time Frame: Baseline, Day 28 ]

Locations (17)

FacilityCityStateZIPSite coordinators
Neurocrine Clinical SiteBirminghamAlabama35249-
Neurocrine Clinical SiteHuntsvilleAlabama35801-
Neurocrine Clinical SiteRiversideCalifornia92506-
Neurocrine Clinical SiteSan DiegoCalifornia92103-
Neurocrine Clinical SiteSan FranciscoCalifornia94143-
Neurocrine Clinical SiteTorranceCalifornia90502-
Neurocrine Clinical SiteHartfordConnecticut06106-
Neurocrine Clinical SitePalmetto BayFlorida33158-
Neurocrine Clinical SiteGaithersburgMaryland20877-
Neurocrine Clinical SiteWeldon SpringMissouri63304-
Neurocrine Clinical SiteColumbusOhio43221-
Neurocrine Clinical SiteNorth CantonOhio44720-
Neurocrine Clinical SiteOklahoma CityOklahoma73112-
Neurocrine Clinical SiteMemphisTennessee38119-
Neurocrine Clinical SiteDallasTexas75390-
Neurocrine Clinical SiteHoustonTexas77030-
Neurocrine Clinical SiteDraperUtah84020-

Find similar trials in Birmingham, AL

By condition
Depression
By specialty
PsychiatryMental healthBehavioral health
By research site
Neurocrine Clinical Site· Birmingham, ALNeurocrine Clinical Site· Huntsville, ALNeurocrine Clinical Site· Riverside, CANeurocrine Clinical Site· San Diego, CANeurocrine Clinical Site· San Francisco, CANeurocrine Clinical Site· Torrance, CA

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