Study of Lumateperone as Adjunctive Therapy in the Treatment of Patients With Major Depressive Disorder
NCT ID: NCT05850689
Last Updated: 2025-07-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
470 participants
INTERVENTIONAL
2023-05-02
2026-10-31
Brief Summary
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Detailed Description
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* 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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Lumateperone 42 mg
Lumateperone
Lumateperone 42 mg capsules administered orally, once daily
Placebo
Placebo
Matching capsules administered orally, once daily
Interventions
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Lumateperone
Lumateperone 42 mg capsules administered orally, once daily
Placebo
Matching capsules administered orally, once daily
Eligibility Criteria
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Inclusion Criteria
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 12 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 (less than 50% improvement) to 2 or more ADTs in the current MDE 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. 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.
18 Years
65 Years
ALL
No
Sponsors
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Intra-Cellular Therapies, Inc.
INDUSTRY
Responsible Party
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Locations
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Clinical Site
Huntsville, Alabama, United States
Clinical Site
Pico Rivera, California, United States
Clinical Site
Farmington, Connecticut, United States
Clinical Site
Clermont, Florida, United States
Clinical Site
Hialeah, Florida, United States
Clinical Site
Miami, Florida, United States
Clinical Site
Miami, Florida, United States
Clinical Site
Miami, Florida, United States
Clinical Site
Tampa, Florida, United States
Clinical Site
Atlanta, Georgia, United States
Clinical Site
Decatur, Georgia, United States
Clinical Site
Kansas City, Kansas, United States
Clinical Site
Kansas City, Kansas, United States
Clinical Site
Overland Park, Kansas, United States
Clinical Site
Methuen, Massachusetts, United States
Clinical Site
O'Fallon, Missouri, United States
Clinical Site
New York, New York, United States
Clinical Site
Avon Lake, Ohio, United States
Clinical Site
Cincinnati, Ohio, United States
Clinical Site
Columbus, Ohio, United States
Clinical Site
Philadelphia, Pennsylvania, United States
Clinical Site
Houston, Texas, United States
Clinical Site
Richardson, Texas, United States
Clinical Site
Bellevue, Washington, United States
Clinical Site
Cherven Bryag, , Bulgaria
Clinical Site
Kardzhali, , Bulgaria
Clinical Site
Pleven, , Bulgaria
Clinical Site
Sofia, , Bulgaria
Clinical Site
Sofia, , Bulgaria
Clinical Site
Sofia, , Bulgaria
Clincal Site
Stara Zagora, , Bulgaria
Clinical Site
Varna, , Bulgaria
Clinical Site
Douai, , France
Clinical Site
Nantes, , France
Clinical Site
Nîmes, , France
Clinical Site
Paris, , France
Clinical Site
Poitiers, , France
Clinical Site
Ahmedabad, Gujarat, India
Clinical Site
Ahmedabad, Gujarat, India
Clinical Site
Rajkot, Gujarat, India
Clinical Site
Surat, Gujarat, India
Clinical Site
Kolhāpur, Maharahstra, India
Clinical Site
Bārāmati, Maharashtra, India
Clinical Site
Nagpur, Maharashtra, India
Clinical Site
Pune, Maharashtra, India
Clinical Site
Wardha, Maharashtra, India
Clinical Site
Ajmer, Rajasthan, India
Clinical Site
Kaunas, , Lithuania
Clinical Site
Ziegzdriai, , Lithuania
Clinical Site
Belgrade, , Serbia
Clinical Site
Gornja Toponica, , Serbia
Clinical Site
Kovin, , Serbia
Clinical Site
Kragujevac, , Serbia
Clinical Site
Niš, , Serbia
Clinical Site
Novi Kneževac, , Serbia
Clinical Site
Barcelona, , Spain
Clinical Site
Barcelona, , Spain
Clinical Site
Madrid, , Spain
Clinical Site
Sabadell, , Spain
Clinical Site
Zamora, , Spain
Countries
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Central Contacts
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Other Identifiers
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ITI-007-505
Identifier Type: -
Identifier Source: org_study_id
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