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

First listed
Apr 18, 2024
Start date
May 14, 2024
Status verified
Jul 2026
Primary completion
Oct 31, 2031
Completion
Oct 31, 2031

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 (56)

FacilityCityStateZIPSite coordinators
Harmonex Neuroscience ResearchDothanAlabama36303-
Pillar Clinical Research, LLCLittle RockArkansas72204-
Advanced Research Center, IncAnaheimCalifornia92805-
Inland Psychiatric Medical Group IncRedlandsCalifornia92373-
UC Davis Health SystemSacramentoCalifornia95817-
University of California San Diego Medical CenterSan DiegoCalifornia92103-
Next Level Clinical Trials, LLCWest CovinaCalifornia91790-
MCB Clinical Research Centers LLCColorado SpringsColorado80910-
Royal Palm Clinical ResearchFort MyersFlorida33901-
United Research InstituteHialeahFlorida33012-
Advanced Research Institute of MiamiHomesteadFlorida33033-
AP Medical ResearchMiamiFlorida33165-
Care Research Center IncMiamiFlorida33130-
Columbus Clinical Services LLCMiamiFlorida33125-
Envision Trials LLCMiamiFlorida33166-
GTL Medical and Research GroupMiamiFlorida33173-
HealthMed Clinical Center IncMiamiFlorida33134-
Links Clinical TrialsMiamiFlorida33176-
Ocean Blue Medical Research Center Inc.MiamiFlorida33144-
SouthGen Clinical Research LLCMiamiFlorida33186-
Vital Care ResearchMiamiFlorida33122-
New Med Research IncMiami GardensFlorida33056-
The Angel Medical Research CorporationMiami GardensFlorida33169-
Riveldi Biomedical ResearchMiami LakesFlorida33014-
APG Research LLCOrlandoFlorida32803-
Health Synergy Clinical ResearchWest Palm BeachFlorida33407-
Advanced Discovery ResearchAtlantaGeorgia30318-
CenExeli Research LLCAtlantaGeorgia30030-
Salveo Integrative Health IncLawrencevilleGeorgia30046-
CenExeli Research LLC 1SavannahGeorgia31405-
Ann & Robert H. Lurie Children's Hospital of ChicagoChicagoIllinois60611-
Revive Research InstituteElginIllinois60123-
Indiana UniversityIndianapolisIndiana46202-
MTP Psychiatry LLCBaltimoreMaryland21229-
Neurobehavioral Medicine GroupBloomfield HillsMichigan48302-
Midwest Research GroupSaint CharlesMissouri63304-
Washington University School of Medicine Child and Adolescent Psychiatry ClinicSt LouisMissouri63110-
Alivation Research LLCLincolnNebraska68526-
NYU Child Study CenterNew YorkNew York10016-
Haidar Almhana NiedingAvon LakeOhio44012-
University of Cincinnati Medical CenterCincinnatiOhio45219-
Charak Center for Health and WellnessGarfield HeightsOhio44125-
Westlake America ClinicWestlakeOhio44145-
Cutting Edge Research GroupOklahoma CityOklahoma73116-
Sooner Clinical ResearchOklahoma CityOklahoma73116-
SP Research, PLLC (dba Rivus Wellness & Research Institute)Oklahoma CityOklahoma73112-
BioBehavioral Research of Austin PCAustinTexas78759-
The University of Texas at AustinAustinTexas78701-
REX Clinical Trials LLCBeaumontTexas77701-
North Pointe PsychiatryFlower MoundTexas76028-
Kaleidoscope Clinical ResearchHoustonTexas77089-
Red Oak Psychiatry AssociatesHoustonTexas77090-
Perceptive Pharma ResearchRichmondTexas77407-
Virginia Commonwealth UniversityRichmondVirginia23220-
Northwest Clinical Research CenterBellevueWashington98007-
Core Clinical ResearchEverettWashington98201-

Find similar trials in Dothan, AL

By research site
Harmonex Neuroscience Research· Dothan, ALPillar Clinical Research, LLC· Little Rock, ARAdvanced Research Center, Inc· Anaheim, CAInland Psychiatric Medical Group Inc· Redlands, CAUC Davis Health System· Sacramento, CAUniversity of California San Diego Medical Center· San Diego, CA

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