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
Apply to this trial

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

First listed
May 9, 2023
Start date
May 2, 2023
Status verified
Jul 2026
Primary completion
Apr 5, 2027
Completion
Apr 5, 2027

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 (25)

FacilityCityStateZIPSite coordinators
University of Alabama at BirminghamHuntsvilleAlabama35801-
CNRI-Los Angeles, LLCPico RiveraCalifornia90660-
University of Connecticut Health CenterFarmingtonConnecticut06030-
Vertex Clinical ResearchClermontFlorida34711-
New Life Medical Research Center, Inc.HialeahFlorida33012-
Miami Jewish Health SystemMiamiFlorida33137-
Premier Clinical Research InstituteMiamiFlorida33122-
Interventional Psychiatry of Tampa BayTampaFlorida33629-
The Emory ClinicAtlantaGeorgia30329-
CenExeli Research LLCDecaturGeorgia30030-
University of Kansas Medical Center Research InstituteKansas CityKansas66160-
Collective Medical ResearchOverland ParkKansas66210-
ActivMed Practices and ResearchMethuenMassachusetts01844-
Psychiatric Care and Research Center (PCRC)O'FallonMissouri63368-
Bio Behavioral HealthToms RiverNew Jersey08755-
SPRI Clinical Trials, LLCBrooklynNew York11235-
Manhattan Behavioral MedicineNew YorkNew York10036-
Quest Therapeutics of Avon LakeAvon LakeOhio44012-
University of Cincinnati Medical CenterCincinnatiOhio45219-
The Ohio State UniversityColumbusOhio43210-
University of Pennsylvania - Perelman School of MedicinePhiladelphiaPennsylvania19104-
DM Clinical ResearchHoustonTexas77081-
Hawkins Psychiatry, PCMansfieldTexas76063-
Pillar Clinical Research, LLCRichardsonTexas75080-
Northwest Clinical Research CenterBellevueWashington98007-

Find similar trials in Huntsville, AL

By condition
Depression
By specialty
PsychiatryMental healthBehavioral health
By research site
University of Alabama at Birmingham· Huntsville, ALCNRI-Los Angeles, LLC· Pico Rivera, CAUniversity of Connecticut Health Center· Farmington, CTVertex Clinical Research· Clermont, FLNew Life Medical Research Center, Inc.· Hialeah, FLMiami Jewish Health System· Miami, FL

Related Studies