RecruitingPhase 3NCT05850689

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

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

Sponsor

Intra-Cellular Therapies, Inc.

Enrollment

470 participants

Start Date

May 2, 2023

Study Type

INTERVENTIONAL

Conditions

Major Depressive Disorder

Summary

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.

Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether lumateperone — a medication already approved for bipolar depression — can also help reduce symptoms in people with major depressive disorder (MDD) who have not had adequate relief from antidepressant treatment alone. It is being studied as an add-on therapy. **You may be eligible if...** - You are between 18 and 65 years old - You have a confirmed diagnosis of major depressive disorder - Your current depressive episode has lasted at least 8 weeks - You are currently taking an antidepressant but still have significant depression symptoms - Depression symptoms started before taking your current antidepressant **You may NOT be eligible if...** - You have a diagnosis of bipolar I disorder, schizophrenia, or other primary psychotic disorders - You have had a recent suicide attempt or are at high immediate risk - You have significant liver, kidney, or cardiovascular problems - You are pregnant or breastfeeding - You have recently used certain medications that could interact with the study drug Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGLumateperone

Lumateperone 42 mg capsules administered orally, once daily

DRUGPlacebo

Matching capsules administered orally, once daily

Locations(69)

University of Alabama at Birmingham

Huntsville, Alabama, United States

CNRI-Los Angeles, LLC

Pico Rivera, California, United States

University of Connecticut Health Center

Farmington, Connecticut, United States

Vertex Clinical Research

Clermont, Florida, United States

New Life Medical Research Center, Inc.

Hialeah, Florida, United States

Premier Clinical Research Institute

Miami, Florida, United States

Miami Jewish Health System

Miami, Florida, United States

Interventional Psychiatry of Tampa Bay

Tampa, Florida, United States

The Emory Clinic

Atlanta, Georgia, United States

CenExeli Research LLC

Decatur, Georgia, United States

University of Kansas Medical Center Research Institute

Kansas City, Kansas, United States

Collective Medical Research

Overland Park, Kansas, United States

ActivMed Practices and Research

Methuen, Massachusetts, United States

Psychiatric Care and Research Center (PCRC)

O'Fallon, Missouri, United States

Bio Behavioral Health

Toms River, New Jersey, United States

SPRI Clinical Trials, LLC

Brooklyn, New York, United States

Manhattan Behavioral Medicine

New York, New York, United States

Quest Therapeutics of Avon Lake

Avon Lake, Ohio, United States

University of Cincinnati Medical Center

Cincinnati, Ohio, United States

The Ohio State University

Columbus, Ohio, United States

University of Pennsylvania - Perelman School of Medicine

Philadelphia, Pennsylvania, United States

DM Clinical Research

Houston, Texas, United States

Hawkins Psychiatry, PC

Mansfield, Texas, United States

Pillar Clinical Research, LLC

Richardson, Texas, United States

Northwest Clinical Research Center

Bellevue, Washington, United States

Ambulatory for Individual Practice for Specialized Medical Care in Psychiatry Dr. Ivo Natsov ET

Cherven Bryag, Bulgaria

Medical Center Lifemed

Kardzhali, Bulgaria

Medical Center Medconsult-Pleven

Pleven, Bulgaria

Medical Center Mentalcare OOD

Plovdiv, Bulgaria

MHC - Sofia, EOOD

Sofia, Bulgaria

University Multiprofile Hospital for Active Treatment - UMHAT Alexandrovska EAD

Sofia, Bulgaria

Medical Center Hera EOOD

Sofia, Bulgaria

Medical Center Intermedica, OOD

Sofia, Bulgaria

UMHAT Prof. Dr. St. Kirkovich AD

Stara Zagora, Bulgaria

Diagnostic Consulting Center Mladost - M Varna

Varna, Bulgaria

Cabinet Medical des Drs Prizac-Desbonnet Scottez

Douai, France

CHU de Nantes hotel Dieu

Nantes, France

Hopital Caremeau

Nîmes, France

Groupe Hospitalier Pitie-Salpetriere

Paris, France

CH Henri Laborit

Poitiers, France

Ratandeep Surgical Hospital And Endoscopy Clinic

Ahmedabad, India

Sushrusha Navneet Memorial Hospital

Ahmedabad, India

J L N Medical College and Attached Hospitals

Ajmer, India

Baramati Hospital

Bārāmati, India

S P Medical College And Associated Group of Hospitals

Bikaner, India

Post Graduate Institute of Medical Education And Research PGIMER

Chandigarh, India

Gauhati Medical College and Hospital

Guwahati, India

Swastik Hospital

Kolhāpur, India

KIMS-Kingsway Hospitals

Nagpur, India

Divyam Hospital

Palsāna, India

Shree Samarth Hospital

Pune, India

Nagecha Hospital

Rajkot, India

Acharya vinoba bhave rural hospital

Wardha, India

Romuvos Klinika, JSC

Kaunas, Lithuania

Kaunas Hospital of Lithuanian University of Health Sciences Psychiatric Clinic Mariu division

Ziegzdriai, Lithuania

Clinical Center Dr Dragisa Misovic Dedinje

Belgrade, Serbia

Institute of Mental Health Serbia

Belgrade, Serbia

University Clinical Center of Serbia

Belgrade, Serbia

Special Hospital for Psychiatric Diseases Kovin

Kovin, Serbia

University Clinical Center Kragujevac 1

Kragujevac, Serbia

University Clinical Center Kragujevac

Kragujevac, Serbia

University Clinical Center NIS 1

Niš, Serbia

University Clinical Center NIS

Niš, Serbia

Special Hospital for Psychiatric Diseases Sveti Vracevi

Novi Kneževac, Serbia

Hosp Univ Vall D Hebron

Barcelona, Spain

Hosp. Clinic de Barcelona

Barcelona, Spain

Hosp. Univ. Ramon Y Cajal

Madrid, Spain

Hosp.Univ.Parc Tauli

Sabadell, Spain

Hosp. Prov. de Zamora

Zamora, Spain

View Full Details on ClinicalTrials.gov

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