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

Recruiting · NCT05850689 · Interventional (participants receive a specific treatment) · Lead sponsor: Intra-Cellular Therapies, Inc.

View the official record on ClinicalTrials.gov →

Depression

Interventions studied

LumateperonePlacebo

What this trial is about

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.

Who can take part

Age range

18 Years to 65 Years

Sex

All (male and female)

Healthy volunteers

No - a diagnosis or condition is required

Phase

Phase 3

Study type

Interventional (participants receive a specific treatment)

Inclusion criteria

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
bupropion
vilazodone
vortioxetine

Exclusion criteria

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
The patient is considered to be in imminent danger to him/herself or others.
The patient has a first MDE at age 60 years or older.

Where it is running

60 locations listed across 14 US states.

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
Ratandeep Surgical Hospital And Endoscopy Clinic - Ahmedabad, India
Sushrusha Navneet Memorial Hospital - Ahmedabad, India
J L N Medical College and Attached Hospitals - Ajmer, India
Hosp Univ Vall D Hebron - Barcelona, Spain
Hosp. Clinic de Barcelona - Barcelona, Spain
Clinical Center Dr Dragisa Misovic Dedinje - Belgrade, Serbia
Institute of Mental Health Serbia - Belgrade, Serbia
University Clinical Center of Serbia - Belgrade, Serbia
S P Medical College And Associated Group of Hospitals - Bikaner, India
Baramati Hospital - Bārāmati, India
Post Graduate Institute of Medical Education And Research PGIMER - Chandigarh, India
Ambulatory for Individual Practice for Specialized Medical Care in Psychiatry Dr. Ivo Natsov ET - Cherven Bryag, Bulgaria
Cabinet Medical des Drs Prizac-Desbonnet Scottez - Douai, France
Gauhati Medical College and Hospital - Guwahati, India
Medical Center Lifemed - Kardzhali, Bulgaria
Romuvos Klinika, JSC - Kaunas, Lithuania
Swastik Hospital - Kolhāpur, India
Special Hospital for Psychiatric Diseases Kovin - Kovin, Serbia
University Clinical Center Kragujevac 1 - Kragujevac, Serbia
University Clinical Center Kragujevac - Kragujevac, Serbia
Hosp. Univ. Ramon Y Cajal - Madrid, Spain
KIMS-Kingsway Hospitals - Nagpur, India
CHU de Nantes hotel Dieu - Nantes, France
University Clinical Center NIS 1 - Niš, Serbia
University Clinical Center NIS - Niš, Serbia
Special Hospital for Psychiatric Diseases Sveti Vracevi - Novi Kneževac, Serbia
Hopital Caremeau - Nîmes, France
Divyam Hospital - Palsāna, India
Groupe Hospitalier Pitie-Salpetriere - Paris, France
Medical Center Medconsult-Pleven - Pleven, Bulgaria
Medical Center Mentalcare OOD - Plovdiv, Bulgaria
CH Henri Laborit - Poitiers, France
Shree Samarth Hospital - Pune, India
Nagecha Hospital - Rajkot, India
Hosp.Univ.Parc Tauli - Sabadell, Spain

Showing 60 of 69 listed sites. See the official record for the complete list.

Read the full protocol, contacts and eligibility on ClinicalTrials.gov →