NCT05850689From ClinicalTrials.govRecruiting

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

Major Depressive Disorder

At a glance

Phase: Phase 3
Study type: Interventional
Sponsor: Intra-Cellular Therapies, Inc.
Enrolment target: 470
Started: 2 May 2023
Main results due: 5 April 2027
Study sites: 69
Registry updated: 25 September 2026

Can you take part?

Ages 18 years to 65 years.
Open to any sex.
You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full eligibility criteria

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.

What this study is about

In the sponsor’s own words, from the registry.

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.

Study sites(69)

University of Alabama at Birmingham
Huntsville, Alabama, United States
Recruiting
CNRI-Los Angeles, LLC
Pico Rivera, California, United States
Recruiting
University of Connecticut Health Center
Farmington, Connecticut, United States
Recruiting
Vertex Clinical Research
Clermont, Florida, United States
Terminated
New Life Medical Research Center, Inc.
Hialeah, Florida, United States
Suspended
Premier Clinical Research Institute
Miami, Florida, United States
Recruiting
Miami Jewish Health System
Miami, Florida, United States
Recruiting
Interventional Psychiatry of Tampa Bay
Tampa, Florida, United States
Recruiting
The Emory Clinic
Atlanta, Georgia, United States
Recruiting
CenExeli Research LLC
Decatur, Georgia, United States
Recruiting
University of Kansas Medical Center Research Institute
Kansas City, Kansas, United States
Terminated
Collective Medical Research
Overland Park, Kansas, United States
Recruiting
ActivMed Practices and Research
Methuen, Massachusetts, United States
Terminated
Psychiatric Care and Research Center (PCRC)
O'Fallon, Missouri, United States
Recruiting
Bio Behavioral Health
Toms River, New Jersey, United States
Recruiting
SPRI Clinical Trials, LLC
Brooklyn, New York, United States
Recruiting
Manhattan Behavioral Medicine
New York, New York, United States
Recruiting
Quest Therapeutics of Avon Lake
Avon Lake, Ohio, United States
Recruiting
University of Cincinnati Medical Center
Cincinnati, Ohio, United States
Recruiting
The Ohio State University
Columbus, Ohio, United States
Recruiting
University of Pennsylvania - Perelman School of Medicine
Philadelphia, Pennsylvania, United States
Recruiting
DM Clinical Research
Houston, Texas, United States
Recruiting
Hawkins Psychiatry, PC
Mansfield, Texas, United States
Completed
Pillar Clinical Research, LLC
Richardson, Texas, United States
Recruiting
Northwest Clinical Research Center
Bellevue, Washington, United States
Recruiting
Ambulatory for Individual Practice for Specialized Medical Care in Psychiatry Dr. Ivo Natsov ET
Cherven Bryag, Bulgaria
Recruiting
Medical Center Lifemed
Kardzhali, Bulgaria
Recruiting
Medical Center Medconsult-Pleven
Pleven, Bulgaria
Recruiting
Medical Center Mentalcare OOD
Plovdiv, Bulgaria
Recruiting
MHC - Sofia, EOOD
Sofia, Bulgaria
Recruiting
University Multiprofile Hospital for Active Treatment - UMHAT Alexandrovska EAD
Sofia, Bulgaria
Terminated
Medical Center Hera EOOD
Sofia, Bulgaria
Recruiting
Medical Center Intermedica, OOD
Sofia, Bulgaria
Recruiting
UMHAT Prof. Dr. St. Kirkovich AD
Stara Zagora, Bulgaria
Completed
Diagnostic Consulting Center Mladost - M Varna
Varna, Bulgaria
Recruiting
Cabinet Medical des Drs Prizac-Desbonnet Scottez
Douai, France
Recruiting
CHU de Nantes hotel Dieu
Nantes, France
Recruiting
Hopital Caremeau
Nîmes, France
Recruiting
Groupe Hospitalier Pitie-Salpetriere
Paris, France
Recruiting
CH Henri Laborit
Poitiers, France
Recruiting
Ratandeep Surgical Hospital And Endoscopy Clinic
Ahmedabad, India
Suspended
Sushrusha Navneet Memorial Hospital
Ahmedabad, India
Suspended
J L N Medical College and Attached Hospitals
Ajmer, India
Suspended
Baramati Hospital
Bārāmati, India
Recruiting
S P Medical College And Associated Group of Hospitals
Bikaner, India
Recruiting
Post Graduate Institute of Medical Education And Research PGIMER
Chandigarh, India
Recruiting
Gauhati Medical College and Hospital
Guwahati, India
Completed
Swastik Hospital
Kolhāpur, India
Recruiting
KIMS-Kingsway Hospitals
Nagpur, India
Recruiting
Divyam Hospital
Palsāna, India
Recruiting
Shree Samarth Hospital
Pune, India
Recruiting
Nagecha Hospital
Rajkot, India
Completed
Acharya vinoba bhave rural hospital
Wardha, India
Suspended
Romuvos Klinika, JSC
Kaunas, Lithuania
Completed
Kaunas Hospital of Lithuanian University of Health Sciences Psychiatric Clinic Mariu division
Ziegzdriai, Lithuania
Completed
Clinical Center Dr Dragisa Misovic Dedinje
Belgrade, Serbia
Recruiting
Institute of Mental Health Serbia
Belgrade, Serbia
Recruiting
University Clinical Center of Serbia
Belgrade, Serbia
Recruiting
Special Hospital for Psychiatric Diseases Kovin
Kovin, Serbia
Recruiting
University Clinical Center Kragujevac 1
Kragujevac, Serbia
Recruiting

Showing 60 of 69 sites — filter to narrow it down. 54 of the 69 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT05850689. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

Not the right study?

Answer three questions and see the studies recruiting near you, in plain language.

Find a study for me