Study of Lumateperone as Adjunctive Therapy in the Treatment of Patients With Major Depressive Disorder

Part of paid clinical trials in Huntsville, Alabama.

Sponsor
Intra-Cellular Therapies, Inc.
Study ID
NCT05850689
Phase
PHASE3
Status
Recruiting
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Conditions

Eligibility Criteria

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

Interventions

  • Lumateperone — DRUG
    Lumateperone 42 mg capsules administered orally, once daily
  • Placebo — DRUG
    Matching capsules administered orally, once daily

Study Details

This is a multicenter, randomized, double-blind, placebo-controlled parallel-group, fixed-dose study in patients with a primary diagnosis of MDD according to criteria of the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) who have an inadequate response to ongoing ADT.

Key Dates

Start date
May 2, 2023
Status verified
Jun 2025
Primary completion
Sep 30, 2026
Completion
Oct 31, 2026

Study Design

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

Arms

  • Experimental: Lumateperone 42 mg
  • Placebo Comparator: Placebo

Primary Outcome Measure

Montgomery-Asberg Depression Rating Scale [ Time Frame: Day 43 ]

Central Contacts

Locations (24)

FacilityCityStateZIPSite coordinators
Clinical SiteHuntsvilleAlabama35801-
Clinical SitePico RiveraCalifornia90660-
Clinical SiteFarmingtonConnecticut06030-
Clinical SiteClermontFlorida34711-
Clinical SiteHialeahFlorida33012-
Clinical SiteMiamiFlorida33122-
Clinical SiteMiamiFlorida33137-
Clinical SiteMiamiFlorida33180-
Clinical SiteTampaFlorida33629-
Clinical SiteAtlantaGeorgia30322-
Clinical SiteDecaturGeorgia30030-
Clinical SiteKansas CityKansas66103-
Clinical SiteKansas CityKansas66160-
Clinical SiteOverland ParkKansas66210-
Clinical SiteMethuenMassachusetts01844-
Clinical SiteO'FallonMissouri63368-
Clinical SiteNew YorkNew York10036-
Clinical SiteAvon LakeOhio44012-
Clinical SiteCincinnatiOhio45219-
Clinical SiteColumbusOhio43210-
Clinical SitePhiladelphiaPennsylvania19104-
Clinical SiteHoustonTexas77081-
Clinical SiteRichardsonTexas75080-
Clinical SiteBellevueWashington98007-

Find similar trials in Huntsville, AL

By condition
Depression
By specialty
PsychiatryMental healthBehavioral health
By research site
Clinical Site· Huntsville, ALClinical Site· Pico Rivera, CAClinical Site· Farmington, CTClinical Site· Clermont, FLClinical Site· Hialeah, FLClinical Site· Miami, FL

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