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Study identifier: NCT05850689 Synced from ClinicalTrials.gov · August 03, 2026
● Recruiting

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

Condition: Major Depressive Disorder  ·  Sponsor: Intra-Cellular Therapies, Inc.

PhasePhase 3
Planned participants470
Who can joinAll sexes, 18 Years to 65 Years
Healthy volunteersNo

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

Study Contact  ·  844-434-4210  ·  Participate-In-This-Study1@its.jnj.com

Always discuss trial participation with your own doctor first.

Locations (69)

University of Alabama at BirminghamHuntsville, Alabama, United StatesRecruiting
CNRI-Los Angeles, LLCPico Rivera, California, United StatesRecruiting
University of Connecticut Health CenterFarmington, Connecticut, United StatesRecruiting
Vertex Clinical ResearchClermont, Florida, United StatesTerminated
New Life Medical Research Center, Inc.Hialeah, Florida, United StatesSuspended
Premier Clinical Research InstituteMiami, Florida, United StatesRecruiting
Miami Jewish Health SystemMiami, Florida, United StatesRecruiting
Interventional Psychiatry of Tampa BayTampa, Florida, United StatesRecruiting
The Emory ClinicAtlanta, Georgia, United StatesRecruiting
CenExeli Research LLCDecatur, Georgia, United StatesRecruiting
University of Kansas Medical Center Research InstituteKansas City, Kansas, United StatesTerminated
Collective Medical ResearchOverland Park, Kansas, United StatesRecruiting

+ 57 more locations — full list on the registry record.

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