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

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(60)

Clinical Site

Huntsville, Alabama, United States

Clinical Site

Pico Rivera, California, United States

Clinical Site

Farmington, Connecticut, United States

Clinical Site

Clermont, Florida, United States

Clinical Site

Hialeah, Florida, United States

Clinical Site

Miami, Florida, United States

Clinical Site

Miami, Florida, United States

Clinical Site

Miami, Florida, United States

Clinical Site

Tampa, Florida, United States

Clinical Site

Atlanta, Georgia, United States

Clinical Site

Decatur, Georgia, United States

Clinical Site

Kansas City, Kansas, United States

Clinical Site

Kansas City, Kansas, United States

Clinical Site

Overland Park, Kansas, United States

Clinical Site

Methuen, Massachusetts, United States

Clinical Site

O'Fallon, Missouri, United States

Clinical Site

New York, New York, United States

Clinical Site

Avon Lake, Ohio, United States

Clinical Site

Cincinnati, Ohio, United States

Clinical Site

Columbus, Ohio, United States

Clinical Site

Philadelphia, Pennsylvania, United States

Clinical Site

Houston, Texas, United States

Clinical Site

Richardson, Texas, United States

Clinical Site

Bellevue, Washington, United States

Clinical Site

Cherven Bryag, Bulgaria

Clinical Site

Kardzhali, Bulgaria

Clinical Site

Pleven, Bulgaria

Clinical Site

Sofia, Bulgaria

Clinical Site

Sofia, Bulgaria

Clinical Site

Sofia, Bulgaria

Clincal Site

Stara Zagora, Bulgaria

Clinical Site

Varna, Bulgaria

Clinical Site

Douai, France

Clinical Site

Nantes, France

Clinical Site

Nîmes, France

Clinical Site

Paris, France

Clinical Site

Poitiers, France

Clinical Site

Ahmedabad, Gujarat, India

Clinical Site

Ahmedabad, Gujarat, India

Clinical Site

Rajkot, Gujarat, India

Clinical Site

Surat, Gujarat, India

Clinical Site

Kolhāpur, Maharahstra, India

Clinical Site

Bārāmati, Maharashtra, India

Clinical Site

Nagpur, Maharashtra, India

Clinical Site

Pune, Maharashtra, India

Clinical Site

Wardha, Maharashtra, India

Clinical Site

Ajmer, Rajasthan, India

Clinical Site

Kaunas, Lithuania

Clinical Site

Ziegzdriai, Lithuania

Clinical Site

Belgrade, Serbia

Clinical Site

Gornja Toponica, Serbia

Clinical Site

Kovin, Serbia

Clinical Site

Kragujevac, Serbia

Clinical Site

Niš, Serbia

Clinical Site

Novi Kneževac, Serbia

Clinical Site

Barcelona, Spain

Clinical Site

Barcelona, Spain

Clinical Site

Madrid, Spain

Clinical Site

Sabadell, Spain

Clinical Site

Zamora, Spain

View Full Details on ClinicalTrials.gov

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NCT05850689


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