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Recruiting Phase 3 Interventional

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

ClinicalTrials.gov ID: NCT05850689

Public ClinicalTrials.gov record NCT05850689. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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ClinicalTrials.gov public records Last synced Jul 23, 2026, 6:17 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Randomized, Double-Blind, Placebo-controlled Multicenter Study to Assess the Efficacy and Safety of Lumateperone as Adjunctive Therapy in the Treatment of Patients With Major Depressive Disorder

Study identification

NCT ID
NCT05850689
Recruitment status
Recruiting
Study type
Interventional
Phase
Phase 3
Lead sponsor
Intra-Cellular Therapies, Inc.
Industry
Enrollment
470 participants

Conditions and interventions

Interventions

  • Lumateperone Drug
  • Placebo Drug

Drug

Eligibility (public fields only)

Age range
18 Years to 65 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
May 1, 2023
Primary completion
Apr 4, 2027
Completion
Apr 4, 2027
Last update posted
Jul 22, 2026

2023 – 2027

United States locations

U.S. sites
25
U.S. states
14
U.S. cities
24
Facility City State ZIP Site status
University of Alabama at Birmingham Huntsville Alabama 35801 Recruiting
CNRI-Los Angeles, LLC Pico Rivera California 90660 Recruiting
University of Connecticut Health Center Farmington Connecticut 06030 Recruiting
Vertex Clinical Research Clermont Florida 34711 Terminated
New Life Medical Research Center, Inc. Hialeah Florida 33012 Suspended
Premier Clinical Research Institute Miami Florida 33122 Recruiting
Miami Jewish Health System Miami Florida 33137 Recruiting
Interventional Psychiatry of Tampa Bay Tampa Florida 33629 Recruiting
The Emory Clinic Atlanta Georgia 30329 Recruiting
CenExeli Research LLC Decatur Georgia 30030 Recruiting
University of Kansas Medical Center Research Institute Kansas City Kansas 66160 Terminated
Collective Medical Research Overland Park Kansas 66210 Recruiting
ActivMed Practices and Research Methuen Massachusetts 01844 Terminated
Psychiatric Care and Research Center (PCRC) O'Fallon Missouri 63368 Recruiting
Bio Behavioral Health Toms River New Jersey 08755 Recruiting
SPRI Clinical Trials, LLC Brooklyn New York 11235 Recruiting
Manhattan Behavioral Medicine New York New York 10036 Recruiting
Quest Therapeutics of Avon Lake Avon Lake Ohio 44012 Recruiting
University of Cincinnati Medical Center Cincinnati Ohio 45219 Recruiting
The Ohio State University Columbus Ohio 43210 Recruiting
University of Pennsylvania - Perelman School of Medicine Philadelphia Pennsylvania 19104 Recruiting
DM Clinical Research Houston Texas 77081 Recruiting
Hawkins Psychiatry, PC Mansfield Texas 76063 Completed
Pillar Clinical Research, LLC Richardson Texas 75080 Recruiting
Northwest Clinical Research Center Bellevue Washington 98007 Recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 44 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT05850689, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jul 22, 2026 · Synced Jul 23, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT05850689 live on ClinicalTrials.gov.

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