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

May 1, 2025 updated by: Intra-Cellular Therapies, Inc.

A Randomized, Double-Blind, Placebo-controlled Multicenter Study to Assess the Efficacy and Safety of Lumateperone as Adjunctive Therapy in the Treatment of Patients With Major Depressive Disorder

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.

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

The study will be conducted in three periods:

  • Screening Period (up to 2 weeks) during which patient eligibility will be assessed;
  • Double-blind Treatment Period (6 weeks) in which all patients will be randomized to receive placebo or lumateperone 42 mg/day in 1:1 ratio.
  • Safety Follow-up Period (1 week) in which all patients will return to the clinic for a safety follow-up visit approximately one week after the last dose of study treatment.

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.
480

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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Argentina
      • Ciudad Autonoma de Buenos Aires, Argentina, C10154ABQ
        • Clinical Site
    • Ciudad Autonoma Buenos Aires
      • Ciudad Autonoma de Buenos Aires, Ciudad Autonoma Buenos Aires, Argentina, 1058 AAJ
        • Clinical Site
    • Cordoba
      • Córdoba, Cordoba, Argentina, 5000FJF
        • Clinical Site
      • Córdoba, Cordoba, Argentina, 5000
        • Clinical Site
      • Córdoba, Cordoba, Argentina, 5009
        • Clinical Site
      • Córdoba, Cordoba, Argentina, X5003DCE
        • Clinical Site
    • Mendoza
      • Ciudad de Mendoza, Mendoza, Argentina, M5502AHV
        • Clinical Site
    • Santa Fe
      • Rosario, Santa Fe, Argentina, S2000QJI
        • Clinical Site
  • Bulgaria
      • Plovdiv, Bulgaria, 4004
        • Clinical Site
      • Sofia, Bulgaria, 1408
        • Clinical Site
      • Sofia, Bulgaria, 1680
        • Clinical Site
      • Targovishte, Bulgaria, 7700
        • 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
  • Poland
      • Bełchatów, Poland, 97-400
        • Clinical Site
      • Białystok, Poland, 15-404
        • Clinical Site
      • Białystok, Poland, 15-464
        • Clinical Site
      • Białystok, Poland, 15-879
        • Clinical Site
      • Bydgoszcz, Poland, 85-080
        • Clinical Site
      • Gdańsk, Poland, 80-546
        • Clinical Site
      • Gorlice, Poland, 38-300
        • Clinical Site
      • Leszno, Poland, 64-100
        • Clinical Site
      • Pruszcz Gdański, Poland, 83-000
        • Clinical Site
      • Toruń, Poland, 87-100
        • Clinical Site
      • Wrocław, Poland, 50-414
        • Clinical Site
  • Sweden
      • Lund, Sweden, 22222
        • Clinical Site
      • Stockholm, Sweden, 11329
        • Clinical Site
  • United States
    • Arkansas
      • Little Rock, Arkansas, United States, 72211
        • Clinical Site
      • Rogers, Arkansas, United States, 72758
        • Clinical Site
    • California
      • Newport Beach, California, United States, 92660
        • Clinical Site
      • Riverside, California, United States, 92506
        • Clinical Site
      • San Diego, California, United States, 92103
        • Clinical Site
    • Florida
      • Palm Bay, Florida, United States, 32905
        • Clinical Site
      • West Palm Beach, Florida, United States, 33407
        • Clinical Site
    • Georgia
      • Atlanta, Georgia, United States, 30329
        • Clinical Site
    • Kansas
      • Overland Park, Kansas, United States, 66211
        • Clinical Site
    • Maryland
      • Gaithersburg, Maryland, United States, 20877
        • Clinical Site
    • Mississippi
      • Flowood, Mississippi, United States, 39232
        • Clinical Site
    • New York
      • Brooklyn, New York, United States, 11235
        • 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
    • 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. 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 MINI and meets all of the following criteria:

    1. The start of the current major depressive episode (MDE) is at least 8 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 (Visit 1) 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 to ADT (less than 50% improvement) as confirmed by the Investigator 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.
    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.

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

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.
Placebo Comparator: Placebo
Drug: Placebo
Matching capsules administered orally, once daily.
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
Montgomery-Asberg Depression Rating Scale
Time Frame: Day 43
Change from baseline to Day 43 in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score. 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.
Day 43

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
Clinical Global Impression Scale-Severity
Time Frame: Day 43
Change from baseline to Day 43 in the Clinical Global Impression Scale-Severity (CGI-S). The CGI-S is a clinician-rated scale to assess a patient's overall mental health. The scale ranges from 1 (normal, not at all ill) to 7 (among the most extremely ill patients).
Day 43

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.
September 30, 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.
April 12, 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.
April 12, 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 (Actual)

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.
May 9, 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.
May 1, 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.
April 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-007-502

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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