Study of Lumateperone as Adjunctive Therapy in the Treatment of Patients With Major Depressive Disorder
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ClinicalTrials.gov Identifier: NCT05850689 |
Recruitment Status :
Recruiting
First Posted : May 9, 2023
Last Update Posted : January 10, 2024
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Major Depressive Disorder | Drug: Lumateperone Drug: Placebo | Phase 3 |
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 : | 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 |
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 |
- 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.
- 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).
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.
Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Male or female patients between the ages of 18 and 65 years, inclusive;
-
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:
- The start of the current major depressive episode (MDE) is at least 8 weeks but not more than 18 months prior to Screening;
- Has at least moderate severity of illness based on rater-administered MADRS total score ≥ 24 at Screening and at Baseline;
- Has at least moderate severity of illness based on CGI-S score ≥ 4 at Screening and at Baseline;
- Has a Quick Inventory of Depressive Symptomatology-Self Report-16 item (QIDS-SR-16) score ≥ 14 at Screening and at Baseline;
- 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.
-
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:
- citalopram/escitalopram
- fluoxetine
- paroxetine
- sertraline
- duloxetine
- levomilnacipran/milnacipran (if locally approved for MDD)
- venlafaxine/desvenlafaxine
- bupropion
- vilazodone
- vortioxetine
Exclusion Criteria:
-
Within the patient's lifetime, has a confirmed DSM-5 psychiatric diagnosis other than MDD, including:
- Schizophrenia, Schizoaffective Disorder, Schizophreniform Disorder or other psychotic disorder;
- Bipolar Disorder;
-
Within 6 months of Screening, has a confirmed DSM-5 psychiatric diagnosis other than MDD including:
- 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;
- Eating disorder;
- Substance use disorders (excluding nicotine);
- Personality disorder of sufficient severity to have a major impact on the patient's psychiatric status;
- Within 12 months of Screening, has had any other psychiatric condition (other than MDD) that has been the main focus of treatment;
- The patient experiences a ≥ 25% decrease in the MADRS total score between Screening and Baseline;
- The patient experiences a ≥ 25% decrease in the QIDS-SR-16 total score between Screening and Baseline;
-
In the opinion of the Investigator, the patient has a significant risk for suicidal behavior during participation in the study or:
- 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;
- At Screening, the patient has had 1 or more suicide attempts within 2 years prior to Screening;
- At Screening or Baseline, the patient scores ≥ 5 on MADRS Item 10 (Suicidal Thoughts), or
- The patient is considered to be in imminent danger to him/herself or others.
- The patient has a first MDE at age 60 years or older.
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 ClinicalTrials.gov identifier (NCT number): NCT05850689
Contact: ITI Clinical Trials | 646 440-9333 | ITCIClinicalTrials@itci-inc.com |
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 |
Responsible Party: | Intra-Cellular Therapies, Inc. |
ClinicalTrials.gov 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 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Adjunctive MDD Therapy |
Depressive Disorder Depression Depressive Disorder, Major |
Mood Disorders Mental Disorders Behavioral Symptoms |