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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT05850689
Recruitment Status : Recruiting
First Posted : May 9, 2023
Last Update Posted : January 10, 2024
Information provided by (Responsible Party):
Intra-Cellular Therapies, Inc.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Major Depressive Disorder Drug: Lumateperone Drug: Placebo Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 470 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : May 2, 2023
Estimated Primary Completion Date : October 2025
Estimated Study Completion Date : October 2025

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Lumateperone 42 mg Drug: Lumateperone
Lumateperone 42 mg capsules administered orally, once daily

Placebo Comparator: Placebo Drug: Placebo
Matching capsules administered orally, once daily

Primary Outcome Measures :
  1. Montgomery-Asberg Depression Rating Scale [ Time Frame: Day 43 ]
    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.

Secondary Outcome Measures :
  1. Clinical Global Impression Scale-Severity [ Time Frame: Day 43 ]
    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).

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 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 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 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT05850689

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Contact: ITI Clinical Trials 646 440-9333

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United States, California
Clinical Site Recruiting
Pico Rivera, California, United States, 90660
United States, Connecticut
Clinical Site Recruiting
Farmington, Connecticut, United States, 06030
United States, Florida
Clinical Site Recruiting
Clermont, Florida, United States, 34711
Clinical Site Recruiting
Hialeah, Florida, United States, 33012
Clinical Site Recruiting
Miami, Florida, United States, 33122
Clinical Site Not yet recruiting
Miami, Florida, United States, 33180
Clinical Site Recruiting
Tampa, Florida, United States, 33629
United States, Georgia
Clinical Site Recruiting
Decatur, Georgia, United States, 30030
United States, Kansas
Clinical Site Recruiting
Kansas City, Kansas, United States, 66160
Clinical Site Not yet recruiting
Overland Park, Kansas, United States, 66210
United States, Massachusetts
Clinical Site Recruiting
Methuen, Massachusetts, United States, 01844
United States, Missouri
Clinical Site Recruiting
O'Fallon, Missouri, United States, 63368
United States, New York
Clinical Site Recruiting
New York, New York, United States, 10036
United States, Ohio
Clinical Site Recruiting
Avon Lake, Ohio, United States, 44012
Clinical Site Recruiting
Columbus, Ohio, United States, 43210
United States, Pennsylvania
Clinical Site Recruiting
Philadelphia, Pennsylvania, United States, 19104
United States, Texas
Clinical Site Recruiting
Houston, Texas, United States, 77081
Clinical Site Not yet recruiting
Richardson, Texas, United States, 75080
Sponsors and Collaborators
Intra-Cellular Therapies, Inc.
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Responsible Party: Intra-Cellular Therapies, Inc. Identifier: NCT05850689    
Other Study ID Numbers: ITI-007-505
First Posted: May 9, 2023    Key Record Dates
Last Update Posted: January 10, 2024
Last Verified: January 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Intra-Cellular Therapies, Inc.:
Adjunctive MDD Therapy
Additional relevant MeSH terms:
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Depressive Disorder
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms