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

NCT ID NCT05850689

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

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 07, 2026 · Last updated Aug 28, 2026 · Updated 5 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.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 470 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2023

Expected to finish

Apr 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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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

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    59 sites in 6 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

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

    COMPLETED

    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

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