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

NCT05850689 | Recruiting Phase 3 FDA Drug

• 1 other identifier: ITI-007-505
• Study Type: interventional
• Target: 470
• Locations: 7 countries
• Sites: 60

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.

Conditions

Major Depressive Disorder

Keywords

Adjunctive MDD Therapy

Outcome Measures

Primary Outcomes (1)

• Montgomery-Asberg Depression Rating Scale

  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 Outcomes (1)

• Clinical Global Impression Scale-Severity

  Day 43

Study Arms (2)

Lumateperone 42 mg

EXPERIMENTAL

Drug: Lumateperone

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Lumateperone DRUG

Lumateperone 42 mg capsules administered orally, once daily

Lumateperone 42 mg

Placebo DRUG

Matching capsules administered orally, once daily

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 12 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 (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:
• citalopram/escitalopram
• fluoxetine
• paroxetine
• sertraline
• duloxetine
• levomilnacipran/milnacipran (if locally approved for MDD)
• venlafaxine/desvenlafaxine

You may not qualify if:

• 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

Sponsors & Collaborators

• Intra-Cellular Therapies, Inc.: lead

Study Sites (60)

Clinical Site

Huntsville, Alabama, 35801, United States

RECRUITING

Clinical Site

Pico Rivera, California, 90660, United States

RECRUITING

Clinical Site

Farmington, Connecticut, 06030, United States

RECRUITING

Clinical Site

Clermont, Florida, 34711, United States

RECRUITING

Clinical Site

Hialeah, Florida, 33012, United States

RECRUITING

Clinical Site

Miami, Florida, 33122, United States

RECRUITING

Clinical Site

Miami, Florida, 33137, United States

RECRUITING

Clinical Site

Miami, Florida, 33180, United States

NOT YET RECRUITING

Clinical Site

Tampa, Florida, 33629, United States

RECRUITING

Clinical Site

Atlanta, Georgia, 30322, United States

RECRUITING

Clinical Site

Decatur, Georgia, 30030, United States

RECRUITING

Clinical Site

Kansas City, Kansas, 66103, United States

RECRUITING

Clinical Site

Kansas City, Kansas, 66160, United States

RECRUITING

Clinical Site

Overland Park, Kansas, 66210, United States

RECRUITING

Clinical Site

Methuen, Massachusetts, 01844, United States

RECRUITING

Clinical Site

O'Fallon, Missouri, 63368, United States

RECRUITING

Clinical Site

New York, New York, 10036, United States

RECRUITING

Clinical Site

Avon Lake, Ohio, 44012, United States

RECRUITING

Clinical Site

Cincinnati, Ohio, 45219, United States

RECRUITING

Clinical Site

Columbus, Ohio, 43210, United States

RECRUITING

Clinical Site

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

Clinical Site

Houston, Texas, 77081, United States

RECRUITING

Clinical Site

Richardson, Texas, 75080, United States

RECRUITING

Clinical Site

Bellevue, Washington, 98007, United States

RECRUITING

Clinical Site

Cherven Bryag, 5980, Bulgaria

RECRUITING

Clinical Site

Kardzhali, 6600, Bulgaria

RECRUITING

Clinical Site

Pleven, 5800, Bulgaria

RECRUITING

Clinical Site

Sofia, 1202, Bulgaria

RECRUITING

Clinical Site

Sofia, 1431, Bulgaria

RECRUITING

Clinical Site

Sofia, 1510, Bulgaria

RECRUITING

Clincal Site

Stara Zagora, 6000, Bulgaria

RECRUITING

Clinical Site

Varna, 9020, Bulgaria

RECRUITING

Clinical Site

Douai, 59500, France

RECRUITING

Clinical Site

Nantes, 44093, France

RECRUITING

Clinical Site

Nîmes, 30029, France

RECRUITING

Clinical Site

Paris, 75013, France

RECRUITING

Clinical Site

Poitiers, 86021, France

RECRUITING

Clinical Site

Ahmedabad, Gujarat, 380009, India

RECRUITING

Clinical Site

Ahmedabad, Gujarat, 38008, India

RECRUITING

Clinical Site

Rajkot, Gujarat, 360001, India

RECRUITING

Clinical Site

Surat, Gujarat, 394315, India

RECRUITING

Clinical Site

Kolhāpur, Maharahstra, 416001, India

RECRUITING

Clinical Site

Bārāmati, Maharashtra, 413102, India

RECRUITING

Clinical Site

Nagpur, Maharashtra, 440001, India

RECRUITING

Clinical Site

Pune, Maharashtra, 411011, India

RECRUITING

Clinical Site

Wardha, Maharashtra, 442004, India

RECRUITING

Clinical Site

Ajmer, Rajasthan, 305001, India

RECRUITING

Clinical Site

Kaunas, 44279, Lithuania

RECRUITING

Clinical Site

Ziegzdriai, 53136, Lithuania

RECRUITING

Clinical Site

Belgrade, 11000, Serbia

RECRUITING

Clinical Site

Gornja Toponica, 18202, Serbia

RECRUITING

Clinical Site

Kovin, 26220, Serbia

RECRUITING

Clinical Site

Kragujevac, 34000, Serbia

RECRUITING

Clinical Site

Niš, 18000, Serbia

RECRUITING

Clinical Site

Novi Kneževac, 23330, Serbia

RECRUITING

Clinical Site

Barcelona, 08035, Spain

RECRUITING

Clinical Site

Barcelona, 08036, Spain

RECRUITING

Clinical Site

Madrid, 28034, Spain

RECRUITING

Clinical Site

Sabadell, 08208, Spain

RECRUITING

Clinical Site

Zamora, 49021, Spain

RECRUITING

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

lumateperone

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Central Study Contacts

ITI Clinical Trials

CONTACT

646 440-9333; ITCIClinicalTrials@itci-inc.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2023
• First Posted: May 9, 2023
• Study Start: May 2, 2023
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: July 1, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

BU (8); FR (5); US (24); IN (10); LI (2); SE (6); ES (5)