An Open-label Study of Lumateperone as Adjunctive Therapy in the Treatment of Patients With Major Depressive Disorder

October 20, 2025 updated by: Intra-Cellular Therapies, Inc.

An Open-label, Multicenter Trial to Assess the Safety and Tolerability of Lumateperone as Adjunctive Therapy in the Treatment of Patients With Major Depressive Disorder

This is a multicenter, open-label, fixed dose, 26 week study of patients with MDD. Eligible patients from the lead-in studies will enter the Open-label Safety Study at the Screening/Baseline Visit (Visit 1/Day 1), at which point patient eligibility will be assessed and informed consent obtained.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

At the Screening/Baseline Visit (Visit 1/Day 1), which is the same visit as Visit 8/Day 43 of the lead-in study, eligible patients will receive open-label lumateperone 42 mg once daily for approximately 26 weeks. Patients will continue their background ADT from the lead-in study. Patients will be seen for weekly visits through Visit 5/Week 4. Thereafter, visits will occur every two weeks. A Safety Follow-up visit will occur on Visit 17/Day 197, approximately 2 weeks after the last dose of open-label lumateperone 42 mg.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
812

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Bulgaria
      • Burgas, Bulgaria, 8001
        • Clinical Site
      • Kazanlak, Bulgaria, 6100
        • Clinical Site
      • Novi Iskar, Bulgaria, 1282
        • Clinical Site
      • Pleven, Bulgaria, 5809
        • Clinical Site
      • Plovdiv, Bulgaria, 4004
        • Clinical Site
      • Rousse, Bulgaria, 7003
        • Clinical Site
      • Sofia, Bulgaria, 1408
        • Clinical Site
      • Sofia, Bulgaria, 1680
        • Clinical Site
      • Targovishte, Bulgaria, 7700
        • Clinical Site
      • Tsarev Brod, Bulgaria, 9747
        • Clinical Site
      • Veliko Tarnovo, Bulgaria, 5000
        • Clinical Site
      • Veliko Tarnovo, Bulgaria, 5047
        • Clinical Site
      • Vratsa, Bulgaria, 3001
        • Clinical Site
  • Czechia
      • Brno, Czechia, 60200
        • Clinical Site
      • Brno, Czechia, 615 00
        • Clinical Site
      • Hostivice, Czechia, 253 01
        • Clinical Site
      • Ostrava, Czechia, 708 00
        • Clinical Site
      • Pilsen, Czechia, 301 00
        • Clinical Site
      • Prague, Czechia, 100 00
        • Clinical Site
      • Prague, Czechia, 160 00
        • Clinical Site
      • Prague, Czechia, 186 00
        • Clinical Site
  • Finland
      • Helsinki, Finland, 00100
        • Clinical Site
      • Oulu, Finland, 90100
        • Clinical Site
  • Germany
      • Bad Homburg, Germany, 61348
        • Clinical Site
      • Freiburg im Breisgau, Germany, 79104
        • Clinical Site
      • Hamburg, Germany, 20253
        • Clinical Site
      • Mittweida, Germany, 09648
        • Clinical Site
      • Schwerin, Germany, 19053
        • Clinical Site
      • Westerstede, Germany, 26655
        • Clinical Site
  • Hungary
      • Budapest, Hungary, 1033
        • Clinical Site
      • Budapest, Hungary, 1083
        • Clinical Site
      • Budapest, Hungary, 1134
        • Clinical Site
      • Budapest, Hungary, 1135
        • Clinical Site
      • Debrecen, Hungary, 4032
        • Clinical Site
      • Gyöngyös, Hungary, 3200
        • Clinical Site
  • India
      • Mumbai, India, 400008
        • Clinical Site
      • Nashik, India, 422005
        • Clinical Site
    • Assam
      • Guwahati, Assam, India, 781010
        • Clinical Site
    • Gujarat
      • Ahmedabad, Gujarat, India, 380013
        • Clinical Site
      • Jūnāgadh, Gujarat, India, 362001
        • Clinical Site
      • Vadodara, Gujarat, India, 390021
        • Clinical Site
    • Karnataka
      • Mysore, Karnataka, India, 570001
        • Clinical Site
    • Maharashtra
      • Aurangabad, Maharashtra, India, 431005
        • Clinical Site
      • Nagpur, Maharashtra, India, 440010
        • Clinical Site
      • Nashik, Maharashtra, India, 422001
        • Clinical Site
  • Poland
      • Bełchatów, Poland, 97-400
        • Clinical Site
      • Bialystok, Poland, 15-404
        • Clinical Site
      • Bialystok, Poland, 15-464
        • Clinical Site
      • Bialystok, Poland, 15-879
        • Clinical Site
      • Bydgoszcz, Poland, 85-080
        • Clinical Site
      • Gdansk, Poland, 80-546
        • Clinical Site
      • Gorlice, Poland, 38-300
        • Clinical Site
      • Leszno, Poland, 64-100
        • Clinical Site
      • Pruszcz Gdański, Poland, 83-000
        • Clinical Site
      • Torun, Poland, 87-100
        • Clinical Site
      • Wroclaw, Poland, 50-414
        • Clinical Site
  • Slovakia
      • Bratislava, Slovakia, 82007
        • Clinical Site
      • Košice, Slovakia, 04001
        • Clinical Site
      • Rimavská Sobota, Slovakia, 979 01
        • Clinical Site
      • Svidník, Slovakia, 089 01
        • Clinical Site
      • Vranov nad Topľou, Slovakia, 09301
        • Clinical Site
      • Zlaté Moravce, Slovakia, 953 01
        • Clinical Site
  • South Korea
      • Gwangju, South Korea, 61469
        • Clinical Site
      • Seoul, South Korea, 01830
        • Clinical Site
      • Seoul, South Korea, 03080
        • Clinical Site
      • Seoul, South Korea, 06351
        • Clinical Site
    • North Chungcheong
      • Ansan-si, North Chungcheong, South Korea, 15355
        • Clinical Site
  • Sweden
      • Lund, Sweden, 22222
        • Clinical Site
      • Stockholm, Sweden, 11329
        • Clinical Site
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85012
        • Clinical Site
    • Arkansas
      • Bentonville, Arkansas, United States, 72712
        • Clinical Site
      • Little Rock, Arkansas, United States, 72211
        • Clinical Site
      • Rogers, Arkansas, United States, 72758
        • Clinical Site
    • California
      • Culver City, California, United States, 90230
        • Clinical Site
      • Glendale, California, United States, 91206
        • Clinical Site
      • Newport Beach, California, United States, 92660
        • Clinical Site
      • Oceanside, California, United States, 92056
        • Clinical Site
      • Redlands, California, United States, 92374
        • Clinical Site
      • Riverside, California, United States, 92506
        • Clinical Site
      • San Diego, California, United States, 92103
        • Clinical Site
      • Sherman Oaks, California, United States, 91403
        • Clinical Site
      • Temecula, California, United States, 92951
        • Clinical Site
      • Upland, California, United States, 91786
        • Clinical Site
    • Florida
      • Fort Lauderdale, Florida, United States, 33319
        • Clinical Site
      • Jacksonville, Florida, United States, 32256
        • Clinical Site
      • Orlando, Florida, United States, 32801
        • Clinical Site
      • Palm Bay, Florida, United States, 32905
        • Clinical Site
      • West Palm Beach, Florida, United States, 33407
        • Clinical Site
    • Georgia
      • Atlanta, Georgia, United States, 30331
        • Clinical Site
      • Atlanta, Georgia, United States, 30328
        • Clinical Site
      • Atlanta, Georgia, United States, 30329
        • Clinical Site
      • Decatur, Georgia, United States, 30030
        • Clinical Site
    • Illinois
      • Joliet, Illinois, United States, 60435
        • Clinical Site
    • Kansas
      • Overland Park, Kansas, United States, 66211
        • Clinical Site
    • Maryland
      • Gaithersburg, Maryland, United States, 20877
        • Clinical Site
    • Massachusetts
      • Boston, Massachusetts, United States, 02131
        • Clinical Site
    • Mississippi
      • Flowood, Mississippi, United States, 39232
        • Clinical Site
    • Missouri
      • Saint Charles, Missouri, United States, 63304
        • Clinical Site
    • New Jersey
      • Berlin, New Jersey, United States, 08009
        • Clinical Site
      • Toms River, New Jersey, United States, 08755
        • Clinical Site
    • New York
      • Brooklyn, New York, United States, 11235
        • Clinical Site
      • Cedarhurst, New York, United States, 11516
        • Clinical Site
      • Mount Kisco, New York, United States, 10549
        • Clinical Site
    • North Carolina
      • Charlotte, North Carolina, United States, 28211
        • Clinical Site
    • Pennsylvania
      • Allentown, Pennsylvania, United States, 18104
        • Clinical Site
      • Media, Pennsylvania, United States, 19063
        • Clinical Site
      • Plymouth Meeting, Pennsylvania, United States, 19462
        • Clinical Site
    • Texas
      • Austin, Texas, United States, 78737
        • Clinical Site
    • Washington
      • Bellevue, Washington, United States, 98007
        • Clinical Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Lumateperone 42 mg
Drug: Lumateperone
Lumateperone 42 mg capsules administered orally, once daily

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
The Number and Percentage of Patients Reporting Treatment Emergent Adverse Events
Time Frame: 26 weeks
An AE that occurs during the Open-label Treatment Period will be considered a treatment-emergent AE (TEAE) if it was not present before the date of the first dose of open-label lumateperone or was present before the date of the first dose of open-label lumateperone but changed in severity during the Open-label Treatment Period.
26 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change From Baseline in One of the 6 Week Double-blind Lead-in Studies (NCT04985942 & NCT05061706) to the End of the Open-Label Treatment Period (a Combined Total of up to 32 Weeks) in the Montgomery-Åsberg Depression Rating Scale
Time Frame: 32 weeks
The MADRS is a clinician-rated 10 item scale to assess depressive symptoms. Each item is rated on a 7-point scale from 0-6. The total score ranges from 0 to 60 with a higher score indicating increased severity of depressive symptoms.
32 weeks
Change From Baseline in One of the 6 Week Double-blind Lead-in Studies (NCT04985942 & NCT05061706) to the End of the Open-Label Treatment Period (a Combined Total of up to 32 Weeks) in the Clinical Global Impression Scale-Severity
Time Frame: 32 weeks
The CGI-S is a clinician-rated scale to assess a patient's overall mental health. The scale ranges from 1 (normal, not ta all ill) to 7 (among the most extremely ill patients).
32 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Intra-Cellular Therapies, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 8, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 14, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 23, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 20, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 20, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 29, 2021

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 3, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 20, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ITI-007-503

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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