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

NCT05850689 | Recruiting Phase 3 FDA Drug

• 1 other identifier: ITI-007-505
• Study Type: interventional
• Target: 470
• Locations: 7 countries
• Sites: 69

Brief 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.

Conditions

Major Depressive Disorder

Keywords

Adjunctive MDD Therapy

Outcome Measures

Primary Outcomes (1)

• Montgomery-Asberg Depression Rating Scale

  The MADRS is a clinician-rated 10 item scale to assess depressive symptoms. Each item is rated on a 7-point scale from 0-6. The total score ranges from 0 to 60 with a higher score indicating increased severity of depressive symptoms.

  Day 43

Secondary Outcomes (1)

• Clinical Global Impression Scale-Severity

  Day 43

Study Arms (2)

Lumateperone 42 mg

EXPERIMENTAL

Drug: Lumateperone

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Placebo DRUG

Matching capsules administered orally, once daily

Placebo

Lumateperone DRUG

Lumateperone 42 mg capsules administered orally, once daily

Lumateperone 42 mg

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female patients between the ages of 18 and 65 years, inclusive;
• 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:
• The start of the current major depressive episode (MDE) is at least 12 weeks but not more than 18 months prior to Screening;
• Has at least moderate severity of illness based on rater-administered MADRS total score ≥ 24 at Screening and at Baseline;
• Has at least moderate severity of illness based on CGI-S score ≥ 4 at Screening and at Baseline;
• Has a Quick Inventory of Depressive Symptomatology-Self Report-16 item (QIDS-SR-16) score ≥ 14 at Screening and at Baseline;
• 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.
• 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:
• citalopram/escitalopram
• fluoxetine
• paroxetine
• sertraline
• duloxetine
• levomilnacipran/milnacipran (if locally approved for MDD)
• venlafaxine/desvenlafaxine

You may not qualify if:

• Within the patient's lifetime, has a confirmed DSM-5 psychiatric diagnosis other than MDD, including:
• Schizophrenia, Schizoaffective Disorder, Schizophreniform Disorder or other psychotic disorder;
• Bipolar Disorder;
• Within 6 months of Screening, has a confirmed DSM-5 psychiatric diagnosis other than MDD including:
• 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;
• Eating disorder;
• Substance use disorders (excluding nicotine);
• Personality disorder of sufficient severity to have a major impact on the patient's psychiatric status;
• Within 12 months of Screening, has had any other psychiatric condition (other than MDD) that has been the main focus of treatment;
• The patient experiences a ≥ 25% decrease in the MADRS total score between Screening and Baseline;
• The patient experiences a ≥ 25% decrease in the QIDS-SR-16 total score between Screening and Baseline;
• In the opinion of the Investigator, the patient has a significant risk for suicidal behavior during participation in the study or:
• 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;
• At Screening, the patient has had 1 or more suicide attempts within 2 years prior to Screening;
• At Screening or Baseline, the patient scores ≥ 5 on MADRS Item 10 (Suicidal Thoughts), or

Sponsors & Collaborators

• Intra-Cellular Therapies, Inc.: lead

Study Sites (69)

University of Alabama at Birmingham

Huntsville, Alabama, 35801, United States

RECRUITING

CNRI-Los Angeles, LLC

Pico Rivera, California, 90660, United States

RECRUITING

University of Connecticut Health Center

Farmington, Connecticut, 06030, United States

RECRUITING

Vertex Clinical Research

Clermont, Florida, 34711, United States

TERMINATED

New Life Medical Research Center, Inc.

Hialeah, Florida, 33012, United States

SUSPENDED

Premier Clinical Research Institute

Miami, Florida, 33122, United States

RECRUITING

Miami Jewish Health System

Miami, Florida, 33137, United States

RECRUITING

Interventional Psychiatry of Tampa Bay

Tampa, Florida, 33629, United States

RECRUITING

The Emory Clinic

Atlanta, Georgia, 30329, United States

RECRUITING

CenExeli Research LLC

Decatur, Georgia, 30030, United States

RECRUITING

University of Kansas Medical Center Research Institute

Kansas City, Kansas, 66160, United States

TERMINATED

Collective Medical Research

Overland Park, Kansas, 66210, United States

RECRUITING

ActivMed Practices and Research

Methuen, Massachusetts, 01844, United States

TERMINATED

Psychiatric Care and Research Center (PCRC)

O'Fallon, Missouri, 63368, United States

RECRUITING

Bio Behavioral Health

Toms River, New Jersey, 08755, United States

RECRUITING

SPRI Clinical Trials, LLC

Brooklyn, New York, 11235, United States

RECRUITING

Manhattan Behavioral Medicine

New York, New York, 10036, United States

RECRUITING

Quest Therapeutics of Avon Lake

Avon Lake, Ohio, 44012, United States

RECRUITING

University of Cincinnati Medical Center

Cincinnati, Ohio, 45219, United States

RECRUITING

The Ohio State University

Columbus, Ohio, 43210, United States

RECRUITING

University of Pennsylvania - Perelman School of Medicine

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

DM Clinical Research

Houston, Texas, 77081, United States

RECRUITING

Hawkins Psychiatry, PC

Mansfield, Texas, 76063, United States

COMPLETED

Pillar Clinical Research, LLC

Richardson, Texas, 75080, United States

RECRUITING

Northwest Clinical Research Center

Bellevue, Washington, 98007, United States

RECRUITING

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

Cherven Bryag, 5980, Bulgaria

RECRUITING

Medical Center Lifemed

Kardzhali, 6600, Bulgaria

RECRUITING

Medical Center Medconsult-Pleven

Pleven, 5800, Bulgaria

RECRUITING

Medical Center Mentalcare OOD

Plovdiv, 4004, Bulgaria

RECRUITING

MHC - Sofia, EOOD

Sofia, 1202, Bulgaria

RECRUITING

University Multiprofile Hospital for Active Treatment - UMHAT Alexandrovska EAD

Sofia, 1431, Bulgaria

TERMINATED

Medical Center Hera EOOD

Sofia, 1510, Bulgaria

RECRUITING

Medical Center Intermedica, OOD

Sofia, 1680, Bulgaria

RECRUITING

UMHAT Prof. Dr. St. Kirkovich AD

Stara Zagora, 6003, Bulgaria

COMPLETED

Diagnostic Consulting Center Mladost - M Varna

Varna, 9020, Bulgaria

RECRUITING

Cabinet Medical des Drs Prizac-Desbonnet Scottez

Douai, 59500, France

RECRUITING

CHU de Nantes hotel Dieu

Nantes, 44093, France

RECRUITING

Hopital Caremeau

Nîmes, 30029, France

RECRUITING

Groupe Hospitalier Pitie-Salpetriere

Paris, 75012, France

RECRUITING

CH Henri Laborit

Poitiers, 86021, France

RECRUITING

Ratandeep Surgical Hospital And Endoscopy Clinic

Ahmedabad, 380008, India

SUSPENDED

Sushrusha Navneet Memorial Hospital

Ahmedabad, 380009, India

SUSPENDED

J L N Medical College and Attached Hospitals

Ajmer, 305001, India

SUSPENDED

Baramati Hospital

Bārāmati, 413102, India

RECRUITING

S P Medical College And Associated Group of Hospitals

Bikaner, 334001, India

RECRUITING

Post Graduate Institute of Medical Education And Research PGIMER

Chandigarh, 160012, India

RECRUITING

Gauhati Medical College and Hospital

Guwahati, 781032, India

COMPLETED

Swastik Hospital

Kolhāpur, 416001, India

RECRUITING

KIMS-Kingsway Hospitals

Nagpur, 440001, India

RECRUITING

Divyam Hospital

Palsāna, 394315, India

RECRUITING

Shree Samarth Hospital

Pune, 411011, India

RECRUITING

Nagecha Hospital

Rajkot, 360001, India

COMPLETED

Acharya vinoba bhave rural hospital

Wardha, 442004, India

SUSPENDED

Romuvos Klinika, JSC

Kaunas, LT-44279, Lithuania

COMPLETED

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

Ziegzdriai, 53136, Lithuania

COMPLETED

Clinical Center Dr Dragisa Misovic Dedinje

Belgrade, 11000, Serbia

RECRUITING

Institute of Mental Health Serbia

Belgrade, 11000, Serbia

RECRUITING

University Clinical Center of Serbia

Belgrade, 11000, Serbia

RECRUITING

Special Hospital for Psychiatric Diseases Kovin

Kovin, 26220, Serbia

RECRUITING

University Clinical Center Kragujevac 1

Kragujevac, 34000, Serbia

RECRUITING

University Clinical Center Kragujevac

Kragujevac, 34000, Serbia

RECRUITING

University Clinical Center NIS 1

Niš, 18000, Serbia

RECRUITING

University Clinical Center NIS

Niš, 18000, Serbia

RECRUITING

Special Hospital for Psychiatric Diseases Sveti Vracevi

Novi Kneževac, 23330, Serbia

RECRUITING

Hosp Univ Vall D Hebron

Barcelona, 08035, Spain

RECRUITING

Hosp. Clinic de Barcelona

Barcelona, 08036, Spain

RECRUITING

Hosp. Univ. Ramon Y Cajal

Madrid, 28034, Spain

RECRUITING

Hosp.Univ.Parc Tauli

Sabadell, 08208, Spain

RECRUITING

Hosp. Prov. de Zamora

Zamora, 49021, Spain

RECRUITING

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

lumateperone

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Study Officials

• Intra-Cellular Therapies, Inc. Clinical Trial

  Intra-Cellular Therapies, Inc.

  STUDY DIRECTOR

Central Study Contacts

Study Contact

CONTACT

844-434-4210; Participate-In-This-Study1@its.jnj.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2023
• First Posted: May 9, 2023
• Study Start: May 2, 2023
• Primary Completion (Estimated): April 5, 2027
• Study Completion (Estimated): April 5, 2027
• Last Updated: September 25, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

SE (9); FR (5); ES (5); US (25); BU (10); IN (13); LI (2)