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New depression combo drug shows promise in large safety trial

NCT ID NCT05061719

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 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked at the safety of adding lumateperone to standard antidepressants for people with major depressive disorder. Over 800 adults who completed earlier studies took the drug for 26 weeks. The main goal was to track side effects, with a focus on how well people tolerated the combination treatment.

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

812 people

The number who actually took part.

Started

Oct 2021

Finished

Oct 2024

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. In the opinion of the Investigator, patients must have safely completed the lead-in study. 2. Patient is taking their ADT as prescribed from the lead-in study. Exclusion Criteria: 1. In the opinion of the Investigator, the patient is unable to comply with study procedures or judged to be inappropriate for the study. 2. In the opinion of the Investigator, the patient has a significant risk for suicidal behavior during the course of her/his participation in the study or is considered to be an imminent danger to her/himself or others, and/or: 1. At the Screening/Baseline Visit, the patient scores "yes" on Suicidal Ideation Items 4 or 5 of the C SSRS "Since Last Visit" version; 2. At the Screening/Baseline visit, the patient scores ≥ 5 on the MADRS Item 10 (Suicidal Thoughts). 3. Based on the Investigator's clinical judgement, any abnormal clinical laboratory test or ECG results obtained throughout the lead-in study that are considered clinically significant and preclude safe participation in the study.

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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

Contacts and locations

Locations

  • Clinical SIte

    Torun, 87-100, Poland

  • Clinical Site

    Phoenix, Arizona, 85012, United States

  • Clinical Site

    Bentonville, Arkansas, 72712, United States

  • Clinical Site

    Little Rock, Arkansas, 72211, United States

  • Clinical Site

    Rogers, Arkansas, 72758, United States

  • Clinical Site

    Culver City, California, 90230, United States

  • Clinical Site

    Glendale, California, 91206, United States

  • Clinical Site

    Newport Beach, California, 92660, United States

  • Clinical Site

    Oceanside, California, 92056, United States

  • Clinical Site

    Redlands, California, 92374, United States

  • Clinical Site

    Riverside, California, 92506, United States

  • Clinical Site

    San Diego, California, 92103, United States

  • Clinical Site

    Sherman Oaks, California, 91403, United States

  • Clinical Site

    Temecula, California, 92951, United States

  • Clinical Site

    Upland, California, 91786, United States

  • Clinical Site

    Fort Lauderdale, Florida, 33319, United States

  • Clinical Site

    Jacksonville, Florida, 32256, United States

  • Clinical Site

    Orlando, Florida, 32801, United States

  • Clinical Site

    Palm Bay, Florida, 32905, United States

  • Clinical Site

    West Palm Beach, Florida, 33407, United States

  • Clinical Site

    Atlanta, Georgia, 30328, United States

  • Clinical Site

    Atlanta, Georgia, 30329, United States

  • Clinical Site

    Atlanta, Georgia, 30331, United States

  • Clinical Site

    Decatur, Georgia, 30030, United States

  • Clinical Site

    Joliet, Illinois, 60435, United States

  • Clinical Site

    Overland Park, Kansas, 66211, United States

  • Clinical Site

    Gaithersburg, Maryland, 20877, United States

  • Clinical Site

    Boston, Massachusetts, 02131, United States

  • Clinical Site

    Flowood, Mississippi, 39232, United States

  • Clinical Site

    Saint Charles, Missouri, 63304, United States

  • Clinical Site

    Berlin, New Jersey, 08009, United States

  • Clinical Site

    Toms River, New Jersey, 08755, United States

  • Clinical Site

    Brooklyn, New York, 11235, United States

  • Clinical Site

    Cedarhurst, New York, 11516, United States

  • Clinical Site

    Mount Kisco, New York, 10549, United States

  • Clinical Site

    Charlotte, North Carolina, 28211, United States

  • Clinical Site

    Allentown, Pennsylvania, 18104, United States

  • Clinical Site

    Media, Pennsylvania, 19063, United States

  • Clinical Site

    Plymouth Meeting, Pennsylvania, 19462, United States

  • Clinical Site

    Austin, Texas, 78737, United States

  • Clinical Site

    Bellevue, Washington, 98007, United States

  • Clinical Site

    Burgas, 8001, Bulgaria

  • Clinical Site

    Kazanlak, 6100, Bulgaria

  • Clinical Site

    Novi Iskar, 1282, Bulgaria

  • Clinical Site

    Pleven, 5809, Bulgaria

  • Clinical Site

    Plovdiv, 4004, Bulgaria

  • Clinical Site

    Rousse, 7003, Bulgaria

  • Clinical Site

    Sofia, 1408, Bulgaria

  • Clinical Site

    Sofia, 1680, Bulgaria

  • Clinical Site

    Targovishte, 7700, Bulgaria

  • Clinical Site

    Tsarev Brod, 9747, Bulgaria

  • Clinical Site

    Veliko Tarnovo, 5000, Bulgaria

  • Clinical Site

    Veliko Tarnovo, 5047, Bulgaria

  • Clinical Site

    Vratsa, 3001, Bulgaria

  • Clinical Site

    Brno, 60200, Czechia

  • Clinical Site

    Hostivice, 253 01, Czechia

  • Clinical Site

    Ostrava, 708 00, Czechia

  • Clinical Site

    Pilsen, 301 00, Czechia

  • Clinical Site

    Prague, 100 00, Czechia

  • Clinical Site

    Prague, 160 00, Czechia

  • Clinical Site

    Prague, 186 00, Czechia

  • Clinical Site

    Helsinki, 00100, Finland

  • Clinical Site

    Oulu, 90100, Finland

  • Clinical Site

    Bad Homburg, 61348, Germany

  • Clinical Site

    Freiburg im Breisgau, 79104, Germany

  • Clinical Site

    Hamburg, 20253, Germany

  • Clinical Site

    Mittweida, 09648, Germany

  • Clinical Site

    Schwerin, 19053, Germany

  • Clinical Site

    Westerstede, 26655, Germany

  • Clinical Site

    Budapest, 1033, Hungary

  • Clinical Site

    Budapest, 1083, Hungary

  • Clinical Site

    Budapest, 1134, Hungary

  • Clinical Site

    Budapest, 1135, Hungary

  • Clinical Site

    Debrecen, 4032, Hungary

  • Clinical Site

    Gyöngyös, 3200, Hungary

  • Clinical Site

    Guwahati, Assam, 781010, India

  • Clinical Site

    Ahmedabad, Gujarat, 380013, India

  • Clinical Site

    Jūnāgadh, Gujarat, 362001, India

  • Clinical Site

    Vadodara, Gujarat, 390021, India

  • Clinical Site

    Mysore, Karnataka, 570001, India

  • Clinical Site

    Aurangabad, Maharashtra, 431005, India

  • Clinical Site

    Nagpur, Maharashtra, 440010, India

  • Clinical Site

    Nashik, Maharashtra, 422001, India

  • Clinical Site

    Mumbai, 400008, India

  • Clinical Site

    Nashik, 422005, India

  • Clinical Site

    Bełchatów, 97-400, Poland

  • Clinical Site

    Bialystok, 15-404, Poland

  • Clinical Site

    Bialystok, 15-464, Poland

  • Clinical Site

    Bialystok, 15-879, Poland

  • Clinical Site

    Bydgoszcz, 85-080, Poland

  • Clinical Site

    Gdansk, 80-546, Poland

  • Clinical Site

    Gorlice, 38-300, Poland

  • Clinical Site

    Leszno, 64-100, Poland

  • Clinical Site

    Pruszcz Gdański, 83-000, Poland

  • Clinical Site

    Wroclaw, 50-414, Poland

  • Clinical Site

    Bratislava, 82007, Slovakia

  • Clinical Site

    Košice, 04001, Slovakia

  • Clinical Site

    Rimavská Sobota, 979 01, Slovakia

  • Clinical Site

    Svidník, 089 01, Slovakia

  • Clinical Site

    Vranov nad Topľou, 09301, Slovakia

  • Clinical Site

    Zlaté Moravce, 953 01, Slovakia

  • Clinical Site

    Ansan-si, North Chungcheong, 15355, South Korea

  • Clinical Site

    Gwangju, 61469, South Korea

  • Clinical Site

    Seoul, 01830, South Korea

  • Clinical Site

    Seoul, 03080, South Korea

  • Clinical Site

    Seoul, 06351, South Korea

  • Clinical Site

    Lund, 22222, Sweden

  • Clinical Site

    Stockholm, 11329, Sweden

  • Clinical site

    Brno, 615 00, Czechia

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