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RECRUITING

NCT05850689

PHASE3

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

Sponsor: Intra-Cellular Therapies, Inc.

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

470

Start Date

2023-05-02

Completion Date

2027-04-05

Last Updated

2026-07-07

Healthy Volunteers

Conditions

Major Depressive Disorder

Interventions

DRUG

Lumateperone

Lumateperone 42 mg capsules administered orally, once daily

DRUG

Placebo

Matching capsules administered orally, once daily

Inclusion Criteria: 1. Male or female patients between the ages of 18 and 65 years, inclusive; 2. Meets DSM-5 criteria for MDD (MDD with psychotic features will be acceptable) as confirmed by the Investigator or Sponsor-approved rater using the modified Structured Clinical Interview for DSM-5, Clinical Trials Version (SCID-5-CT) and meets all of the following criteria: 1. The start of the current major depressive episode (MDE) is at least 12 weeks but not more than 18 months prior to Screening; 2. Has at least moderate severity of illness based on rater-administered MADRS total score ≥ 24 at Screening and at Baseline; 3. Has at least moderate severity of illness based on CGI-S score ≥ 4 at Screening and at Baseline; 4. Has a Quick Inventory of Depressive Symptomatology-Self Report-16 item (QIDS-SR-16) score ≥ 14 at Screening and at Baseline; 5. Has sufficient history and medical record confirmation verifying the ADT and the current MDE is causing clinically significant distress or impairment in social, occupational, or other important areas of functioning. 3. Currently having an inadequate response (less than 50% improvement) to 2 or more ADTs in the current MDE as confirmed by the Investigator using the Antidepressant Treatment Response Questionnaire (ATRQ) and taking at least the minimum effective dose (per package insert) of one of the following antidepressants as monotherapy treatment for at least 6 weeks duration: 1. citalopram/escitalopram 2. fluoxetine 3. paroxetine 4. sertraline 5. duloxetine 6. levomilnacipran/milnacipran (if locally approved for MDD) 7. venlafaxine/desvenlafaxine 8. bupropion 9. vilazodone 10. vortioxetine Exclusion Criteria: 1. Within the patient's lifetime, has a confirmed DSM-5 psychiatric diagnosis other than MDD, including: 1. Schizophrenia, Schizoaffective Disorder, Schizophreniform Disorder or other psychotic disorder; 2. Bipolar Disorder; 2. Within 6 months of Screening, has a confirmed DSM-5 psychiatric diagnosis other than MDD including: 1. Anxiety disorders such as Panic Disorder or Generalized Anxiety Disorder; Obsessive-compulsive Disorder; Posttraumatic Stress Disorder as primary diagnoses. Note: Anxiety symptoms may be allowed if secondary to MDD, provided these symptoms do not require concurrent treatment; 2. Eating disorder; 3. Substance use disorders (excluding nicotine); 4. Personality disorder of sufficient severity to have a major impact on the patient's psychiatric status; 5. Within 12 months of Screening, has had any other psychiatric condition (other than MDD) that has been the main focus of treatment; 3. The patient experiences a ≥ 25% decrease in the MADRS total score between Screening and Baseline; 4. The patient experiences a ≥ 25% decrease in the QIDS-SR-16 total score between Screening and Baseline; 5. In the opinion of the Investigator, the patient has a significant risk for suicidal behavior during participation in the study or: 1. At Screening, the patient scores "yes" on Suicidal Ideation Items 4 or 5 of the Columbia-Suicide Severity Rating Scale (C-SSRS) within 6 months prior to Screening, or at Baseline, the patient scores "yes" on Suicidal Ideation Items 4 or 5 since the Screening Visit; 2. At Screening, the patient has had 1 or more suicide attempts within 2 years prior to Screening; 3. At Screening or Baseline, the patient scores ≥ 5 on MADRS Item 10 (Suicidal Thoughts), or 4. The patient is considered to be in imminent danger to him/herself or others. 6. The patient has a first MDE at age 60 years or older.

Locations (68)

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

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

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (68)