Could a new pill boost antidepressants for Tough-to-Treat depression?

NCT ID NCT05850689

Recruiting now Symptom relief Sponsor: Intra-Cellular Therapies, Inc. Source: ClinicalTrials.gov ↗

First seen Jul 07, 2026 · Last updated Jul 24, 2026 · Updated 3 times

Summary

This study tests whether adding lumateperone to standard antidepressant therapy can better relieve depression symptoms in adults aged 18 to 65 with major depressive disorder. Participants receive either lumateperone or a placebo daily for several weeks, and researchers measure changes in depression severity using a standard rating scale. The goal is to see if this combination approach offers extra benefit for those who haven't improved enough with antidepressants alone.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance: Lumateperone
What this could lead to: If successful, this could provide a new add-on treatment option for people with major depressive disorder who do not respond well enough to standard antidepressants alone.
What could go wrong: This is a phase 3 trial, but results may not confirm benefit over placebo. Side effects or lack of significant improvement could limit its use.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Get updates

Get notified about this study

Our safety recommendation!

By submitting, you agree to our Terms of use

Conditions

The condition(s) this trial relates to.

major depressive disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

MAJOR DEPRESSIVE DISORDER

Contacts and locations

Show contact details

Study contacts

Contact

Phone: •••-•••-•••• Email: •••••@•••••

Locations

Acharya vinoba bhave rural hospital
SUSPENDED

Wardha, 442004, India
ActivMed Practices and Research
TERMINATED

Methuen, Massachusetts, 01844, United States
Ambulatory for Individual Practice for Specialized Medical Care in Psychiatry Dr. Ivo Natsov ET
RECRUITING

Cherven Bryag, 5980, Bulgaria
Baramati Hospital
RECRUITING

Bārāmati, 413102, India
Bio Behavioral Health
RECRUITING

Toms River, New Jersey, 08755, United States
CH Henri Laborit
RECRUITING

Poitiers, 86021, France
CHU de Nantes hotel Dieu
RECRUITING

Nantes, 44093, France
CNRI-Los Angeles, LLC
RECRUITING

Pico Rivera, California, 90660, United States
Cabinet Medical des Drs Prizac-Desbonnet Scottez
RECRUITING

Douai, 59500, France
CenExeli Research LLC
RECRUITING

Decatur, Georgia, 30030, United States
Clinical Center Dr Dragisa Misovic Dedinje
RECRUITING

Belgrade, 11000, Serbia
Collective Medical Research
RECRUITING

Overland Park, Kansas, 66210, United States
DM Clinical Research
RECRUITING

Houston, Texas, 77081, United States
Diagnostic Consulting Center Mladost - M Varna
RECRUITING

Varna, 9020, Bulgaria
Divyam Hospital
RECRUITING

Palsāna, 394315, India
Gauhati Medical College and Hospital
COMPLETED

Guwahati, 781032, India
Groupe Hospitalier Pitie-Salpetriere
RECRUITING

Paris, 75012, France
Hawkins Psychiatry, PC
COMPLETED

Mansfield, Texas, 76063, United States
Hopital Caremeau
RECRUITING

Nîmes, 30029, France
Hosp Univ Vall D Hebron
RECRUITING

Barcelona, 08035, Spain
Hosp. Clinic de Barcelona
RECRUITING

Barcelona, 08036, Spain
Hosp. Prov. de Zamora
RECRUITING

Zamora, 49021, Spain
Hosp. Univ. Ramon Y Cajal
RECRUITING

Madrid, 28034, Spain
Hosp.Univ.Parc Tauli
RECRUITING

Sabadell, 08208, Spain
Institute of Mental Health Serbia
RECRUITING

Belgrade, 11000, Serbia
Interventional Psychiatry of Tampa Bay
RECRUITING

Tampa, Florida, 33629, United States
J L N Medical College and Attached Hospitals
SUSPENDED

Ajmer, 305001, India
KIMS-Kingsway Hospitals
RECRUITING

Nagpur, 440001, India
Kaunas Hospital of Lithuanian University of Health Sciences Psychiatric Clinic Mariu division
COMPLETED

Ziegzdriai, 53136, Lithuania
MHC - Sofia, EOOD
RECRUITING

Sofia, 1202, Bulgaria
Manhattan Behavioral Medicine
RECRUITING

New York, New York, 10036, United States
Medical Center Hera EOOD
RECRUITING

Sofia, 1510, Bulgaria
Medical Center Intermedica, OOD
RECRUITING

Sofia, 1680, Bulgaria
Medical Center Lifemed
RECRUITING

Kardzhali, 6600, Bulgaria
Medical Center Medconsult-Pleven
RECRUITING

Pleven, 5800, Bulgaria
Medical Center Mentalcare OOD
RECRUITING

Plovdiv, 4004, Bulgaria
Miami Jewish Health System
RECRUITING

Miami, Florida, 33137, United States
Nagecha Hospital
COMPLETED

Rajkot, 360001, India
New Life Medical Research Center, Inc.
SUSPENDED

Hialeah, Florida, 33012, United States
Northwest Clinical Research Center
RECRUITING

Bellevue, Washington, 98007, United States
Pillar Clinical Research, LLC
RECRUITING

Richardson, Texas, 75080, United States
Post Graduate Institute of Medical Education And Research PGIMER
RECRUITING

Chandigarh, 160012, India
Premier Clinical Research Institute
RECRUITING

Miami, Florida, 33122, United States
Psychiatric Care and Research Center (PCRC)
RECRUITING

O'Fallon, Missouri, 63368, United States
Quest Therapeutics of Avon Lake
RECRUITING

Avon Lake, Ohio, 44012, United States
Ratandeep Surgical Hospital And Endoscopy Clinic
SUSPENDED

Ahmedabad, 380008, India
Romuvos Klinika, JSC
COMPLETED

Kaunas, LT-44279, Lithuania
S P Medical College And Associated Group of Hospitals
RECRUITING

Bikaner, 334001, India
SPRI Clinical Trials, LLC
RECRUITING

Brooklyn, New York, 11235, United States
Shree Samarth Hospital
RECRUITING

Pune, 411011, India
Special Hospital for Psychiatric Diseases Kovin
RECRUITING

Kovin, 26220, Serbia
Special Hospital for Psychiatric Diseases Sveti Vracevi
RECRUITING

Novi Kneževac, 23330, Serbia
Sushrusha Navneet Memorial Hospital
SUSPENDED

Ahmedabad, 380009, India
Swastik Hospital
RECRUITING

Kolhāpur, 416001, India
The Emory Clinic
RECRUITING

Atlanta, Georgia, 30329, United States
The Ohio State University
RECRUITING

Columbus, Ohio, 43210, United States
UMHAT Prof. Dr. St. Kirkovich AD
RECRUITING

Stara Zagora, 6003, Bulgaria
University Clinical Center Kragujevac
RECRUITING

Kragujevac, 34000, Serbia
University Clinical Center Kragujevac 1
RECRUITING

Kragujevac, 34000, Serbia
University Clinical Center NIS
RECRUITING

Niš, 18000, Serbia
University Clinical Center NIS 1
RECRUITING

Niš, 18000, Serbia
University Clinical Center of Serbia
RECRUITING

Belgrade, 11000, Serbia
University Multiprofile Hospital for Active Treatment - UMHAT Alexandrovska EAD
TERMINATED

Sofia, 1431, Bulgaria
University of Alabama at Birmingham
RECRUITING

Huntsville, Alabama, 35801, United States
University of Cincinnati Medical Center
RECRUITING

Cincinnati, Ohio, 45219, United States
University of Connecticut Health Center
RECRUITING

Farmington, Connecticut, 06030, United States
University of Kansas Medical Center Research Institute
TERMINATED

Kansas City, Kansas, 66160, United States
University of Pennsylvania - Perelman School of Medicine
RECRUITING

Philadelphia, Pennsylvania, 19104, United States
Vertex Clinical Research
TERMINATED

Clermont, Florida, 34711, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.