Multicenter Study of Lumateperone for the Treatment of Bipolar Depression in Pediatric Patients

Part of paid clinical trials in Dothan, Alabama.

Sponsor
Intra-Cellular Therapies, Inc.
Study ID
NCT06372964
Phase
PHASE3
Status
Recruiting
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Conditions

  • Bipolar Depression

Eligibility Criteria

Sex
ALL
Age
10 Years - 17 Years
Healthy Volunteers
Not accepted

Interventions

  • Lumateperone — DRUG
    Lumateperone administered orally, once daily.
  • Placebo — DRUG
    Matching placebo administered orally, once daily.

Study Details

This is a multicenter, randomized, double-blind, placebo-controlled study in pediatric patients who are experiencing major depressive episodes (MDEs) associated with a primary diagnosis of bipolar I or bipolar II disorder as confirmed by Kiddie Schedule for Affective Disorders and Schizophrenia for School-Age Children-Present and Lifetime Version (K-SADS-PL), according to criteria of the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM 5).

Key Dates

Start date
May 13, 2024
Status verified
Jul 2025
Primary completion
Apr 30, 2027
Completion
May 31, 2027

Study Design

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

Arms

  • Experimental: Lumateperone
    Lumateperone 42 mg for patient ages 13-17 years and Lumateperone 21 mg for patient ages 10-12 years.
  • Placebo Comparator: Placebo
    Matching placebo

Primary Outcome Measure

Children's Depression Rating Scale-Revised (CDRS-R) [ Time Frame: Week 6 ]

Central Contacts

Locations (52)

FacilityCityStateZIPSite coordinators
Clinical SiteDothanAlabama36303-
Clinical SiteLittle RockArkansas72204-
Clinical SiteAnaheimCalifornia92805-
Clinical SiteRedlandsCalifornia92373-
Clinical SiteSacramentoCalifornia95817-
Clinical SiteSan DiegoCalifornia92103-
Clinical SiteWest CovinaCalifornia91790-
Clinical SiteColorado SpringsColorado80910-
Clinical SiteGainesvilleFlorida32607-
Clinical SiteHialeahFlorida33012-
Clinical SiteHomesteadFlorida33030-
Clinical SiteMiamiFlorida33122-
Clinical SiteMiamiFlorida33125-
Clinical SiteMiamiFlorida33130-
Clinical SiteMiamiFlorida33134-
Clinical SiteMiamiFlorida33144-
Clinical SiteMiamiFlorida33165-
Clinical SiteMiamiFlorida33173-
Clinical SiteMiamiFlorida33176-
Clinical SiteMiamiFlorida33186-
Clinical SiteMiami GardensFlorida33056-
Clinical SiteMiami LakesFlorida33014-
Clinical SiteMiami LakesFlorida33016-
Clinical SiteMiami SpringsFlorida33166-
Clinical SiteOrlandoFlorida32803-
Clinical SiteWest Palm BeachFlorida33407-
Clinical SiteAtlantaGeorgia30318-
Clinical SiteDecaturGeorgia30030-
Clinical SiteLawrencevilleGeorgia30046-
Clinical SiteSavannahGeorgia31405-
Clinical SiteChicagoIllinois60611-
Clinical SiteIndianapolisIndiana46202-
Clinical SiteBaltimoreMaryland21229-
Clinical SiteBloomfield HillsMichigan48302-
Clinical SiteSaint CharlesMissouri63304-
Clinical SiteLincolnNebraska68526-
Clinical SiteKinstonNorth Carolina28504-
Clinical SiteAvon LakeOhio44012-
Clinical SiteCincinnatiOhio45219-
Clinical SiteGarfieldOhio44125-
Clinical SiteWestlakeOhio44145-
Clinical SiteOklahoma CityOklahoma73112-
Clinical SiteOklahoma CityOklahoma73116-
Clinical SiteAustinTexas78759-
Clinical SiteFlower MoundTexas76028-
Clinical SiteFriscoTexas75034-
Clinical SiteHoustonTexas77089-
Clinical SiteHoustonTexas77090-
Clinical SiteRichmondTexas77407-
Clinical SiteRichmondVirginia23220-
Clinical SiteBellevueWashington98007-
Clinical SiteEverettWashington98201-

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