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

NCT05061706 | Completed Phase 3 Results FDA Drug

• 1 other identifier: ITI-007-502
• Study Type: interventional
• Target: 480
• Locations: 7 countries
• Sites: 50

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

  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 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 MINI 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 (Visit 1) 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 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.
• 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 (50)

Clinical Site

Little Rock, Arkansas, 72211, United States

Location

Clinical Site

Rogers, Arkansas, 72758, United States

Location

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Newport Beach, California, 92660, United States

Location

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Riverside, California, 92506, United States

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San Diego, California, 92103, United States

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Palm Bay, Florida, 32905, United States

Location

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West Palm Beach, Florida, 33407, United States

Location

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Atlanta, Georgia, 30329, United States

Location

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Overland Park, Kansas, 66211, United States

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Gaithersburg, Maryland, 20877, United States

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Flowood, Mississippi, 39232, United States

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Brooklyn, New York, 11235, United States

Location

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Charlotte, North Carolina, 28211, United States

Location

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Allentown, Pennsylvania, 18104, United States

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Media, Pennsylvania, 19063, United States

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Plymouth Meeting, Pennsylvania, 19462, United States

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Bellevue, Washington, 98007, United States

Location

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Buenos Aires, Ciudad Autonoma Buenos Aires, 1058 AAJ, Argentina

Location

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Córdoba, Córdoba Province, 5000FJF, Argentina

Location

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Córdoba, Córdoba Province, 5000, Argentina

Location

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Córdoba, Córdoba Province, 5009, Argentina

Location

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Córdoba, Córdoba Province, X5003DCE, Argentina

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Mendoza, Mendoza Province, M5502AHV, Argentina

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Rosario, Santa Fe Province, S2000QJI, Argentina

Location

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Buenos Aires, C10154ABQ, Argentina

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Plovdiv, 4004, Bulgaria

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Sofia, 1408, Bulgaria

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Sofia, 1680, Bulgaria

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Targovishte, 7700, Bulgaria

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Helsinki, 00100, Finland

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Oulu, 90100, Finland

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Bad Homburg, 61348, Germany

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Freiburg im Breisgau, 79104, Germany

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Hamburg, 20253, Germany

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Mittweida, 09648, Germany

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Schwerin, 19053, Germany

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Westerstede, 26655, Germany

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Bełchatów, 97-400, Poland

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Bialystok, 15-404, Poland

Location

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Bialystok, 15-464, Poland

Location

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Bialystok, 15-879, Poland

Location

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Bydgoszcz, 85-080, Poland

Location

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Gdansk, 80-546, Poland

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Gorlice, 38-300, Poland

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Leszno, 64-100, Poland

Location

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Pruszcz Gdański, 83-000, Poland

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Torun, 87-100, Poland

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Wroclaw, 50-414, Poland

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Lund, 22222, Sweden

Location

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Stockholm, 11329, Sweden

Location

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

lumateperone

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Results Point of Contact

• Title: ITI Clinical Trials
• Organization: Intra-Cellular Therapies, Inc.

ITCIClinicalTrials@itci-inc.com

646 440-9333

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

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: September 20, 2021
• First Posted: September 29, 2021
• Study Start: September 30, 2021
• Primary Completion: April 12, 2024
• Study Completion: April 12, 2024
• Last Updated: May 9, 2025
• Results First Posted: March 25, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

FI (2); SE (2); AR (8); US (17); BU (4); DE (6); PL (11)