An Open-label Study of Lumateperone as Adjunctive Therapy in the Treatment of Patients With Major Depressive Disorder

NCT05061719 | Completed Phase 3 Results FDA Drug

• 1 other identifier: ITI-007-503
• Study Type: interventional
• Target: 812
• Locations: 11 countries
• Sites: 109

Brief Summary

This is a multicenter, open-label, fixed dose, 26 week study of patients with MDD. Eligible patients from the lead-in studies will enter the Open-label Safety Study at the Screening/Baseline Visit (Visit 1/Day 1), at which point patient eligibility will be assessed and informed consent obtained.

Conditions

Major Depressive Disorder

Keywords

Adjunctive MDD Therapy

Outcome Measures

Primary Outcomes (1)

• The Number and Percentage of Patients Reporting Treatment Emergent Adverse Events

  An AE that occurs during the Open-label Treatment Period will be considered a treatment-emergent AE (TEAE) if it was not present before the date of the first dose of open-label lumateperone or was present before the date of the first dose of open-label lumateperone but changed in severity during the Open-label Treatment Period.

  26 weeks

Secondary Outcomes (2)

• Change From Baseline in One of the 6 Week Double-blind Lead-in Studies (NCT04985942 & NCT05061706) to the End of the Open-Label Treatment Period (a Combined Total of up to 32 Weeks) in the Montgomery-Åsberg Depression Rating Scale

  32 weeks

• Change From Baseline in One of the 6 Week Double-blind Lead-in Studies (NCT04985942 & NCT05061706) to the End of the Open-Label Treatment Period (a Combined Total of up to 32 Weeks) in the Clinical Global Impression Scale-Severity

  32 weeks

Study Arms (1)

Lumateperone 42 mg

EXPERIMENTAL

Drug: Lumateperone

Interventions

Lumateperone DRUG

Lumateperone 42 mg capsules administered orally, once daily

Lumateperone 42 mg

Eligibility Criteria

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

You may qualify if:

• In the opinion of the Investigator, patients must have safely completed the lead-in study.
• Patient is taking their ADT as prescribed from the lead-in study.

You may not qualify if:

• In the opinion of the Investigator, the patient is unable to comply with study procedures or judged to be inappropriate for the study.
• In the opinion of the Investigator, the patient has a significant risk for suicidal behavior during the course of her/his participation in the study or is considered to be an imminent danger to her/himself or others, and/or:
• At the Screening/Baseline Visit, the patient scores "yes" on Suicidal Ideation Items 4 or 5 of the C SSRS "Since Last Visit" version;
• At the Screening/Baseline visit, the patient scores ≥ 5 on the MADRS Item 10 (Suicidal Thoughts).
• Based on the Investigator's clinical judgement, any abnormal clinical laboratory test or ECG results obtained throughout the lead-in study that are considered clinically significant and preclude safe participation in the study.

Sponsors & Collaborators

• Intra-Cellular Therapies, Inc.: lead

Study Sites (109)

Clinical Site

Phoenix, Arizona, 85012, United States

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Bentonville, Arkansas, 72712, United States

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Little Rock, Arkansas, 72211, United States

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Rogers, Arkansas, 72758, United States

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Culver City, California, 90230, United States

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Glendale, California, 91206, United States

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Newport Beach, California, 92660, United States

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Oceanside, California, 92056, United States

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Redlands, California, 92374, United States

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Riverside, California, 92506, United States

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San Diego, California, 92103, United States

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Sherman Oaks, California, 91403, United States

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Temecula, California, 92951, United States

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Upland, California, 91786, United States

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Fort Lauderdale, Florida, 33319, United States

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Jacksonville, Florida, 32256, United States

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Orlando, Florida, 32801, United States

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Palm Bay, Florida, 32905, United States

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West Palm Beach, Florida, 33407, United States

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Atlanta, Georgia, 30328, United States

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Atlanta, Georgia, 30329, United States

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Atlanta, Georgia, 30331, United States

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Decatur, Georgia, 30030, United States

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Joliet, Illinois, 60435, United States

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Overland Park, Kansas, 66211, United States

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Gaithersburg, Maryland, 20877, United States

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Boston, Massachusetts, 02131, United States

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Flowood, Mississippi, 39232, United States

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Saint Charles, Missouri, 63304, United States

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Berlin, New Jersey, 08009, United States

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Toms River, New Jersey, 08755, United States

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Brooklyn, New York, 11235, United States

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Cedarhurst, New York, 11516, United States

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Mount Kisco, New York, 10549, United States

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Charlotte, North Carolina, 28211, United States

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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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Austin, Texas, 78737, United States

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Bellevue, Washington, 98007, United States

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Burgas, 8001, Bulgaria

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Kazanlak, 6100, Bulgaria

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Novi Iskar, 1282, Bulgaria

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Pleven, 5809, Bulgaria

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Plovdiv, 4004, Bulgaria

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Rousse, 7003, 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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Tsarev Brod, 9747, Bulgaria

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Veliko Tarnovo, 5000, Bulgaria

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Veliko Tarnovo, 5047, Bulgaria

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Vratsa, 3001, Bulgaria

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Brno, 60200, Czechia

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Brno, 615 00, Czechia

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Hostivice, 253 01, Czechia

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Ostrava, 708 00, Czechia

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Pilsen, 301 00, Czechia

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Prague, 100 00, Czechia

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Prague, 160 00, Czechia

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Prague, 186 00, Czechia

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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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Budapest, 1033, Hungary

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Budapest, 1083, Hungary

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Budapest, 1134, Hungary

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Budapest, 1135, Hungary

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Debrecen, 4032, Hungary

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Gyöngyös, 3200, Hungary

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Guwahati, Assam, 781010, India

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Ahmedabad, Gujarat, 380013, India

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Jūnāgadh, Gujarat, 362001, India

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Vadodara, Gujarat, 390021, India

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Mysore, Karnataka, 570001, India

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Aurangabad, Maharashtra, 431005, India

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Nagpur, Maharashtra, 440010, India

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Nashik, Maharashtra, 422001, India

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Mumbai, 400008, India

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Nashik, 422005, India

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Bełchatów, 97-400, Poland

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Bialystok, 15-404, Poland

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Bialystok, 15-464, Poland

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Bialystok, 15-879, Poland

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Bydgoszcz, 85-080, Poland

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Gdansk, 80-546, Poland

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Gorlice, 38-300, Poland

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Leszno, 64-100, Poland

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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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Bratislava, 82007, Slovakia

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Košice, 04001, Slovakia

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Rimavská Sobota, 979 01, Slovakia

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Svidník, 089 01, Slovakia

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Vranov nad Topľou, 09301, Slovakia

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Zlaté Moravce, 953 01, Slovakia

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Ansan-si, North Chungcheong, 15355, South Korea

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Gwangju, 61469, South Korea

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Seoul, 01830, South Korea

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Seoul, 03080, South Korea

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Seoul, 06351, South Korea

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Lund, 22222, Sweden

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Stockholm, 11329, Sweden

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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: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 20, 2021
• First Posted: September 29, 2021
• Study Start: October 8, 2021
• Primary Completion: October 14, 2024
• Study Completion: October 23, 2024
• Last Updated: November 3, 2025
• Results First Posted: November 3, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (40); FI (2); SL (6); DE (6); BU (13); KR (5); IN (10); PL (11); CZ (8); SE (2); HU (6)