An Open-label Study of Lumateperone as Adjunctive Therapy in the Treatment of Patients With Major Depressive Disorder
NCT ID: NCT05061719
Last Updated: 2025-11-03
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
812 participants
INTERVENTIONAL
2021-10-08
2024-10-23
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Lumateperone 42 mg
Lumateperone
Lumateperone 42 mg capsules administered orally, once daily
Interventions
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Lumateperone
Lumateperone 42 mg capsules administered orally, once daily
Eligibility Criteria
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Inclusion Criteria
2. Patient is taking their ADT as prescribed from the lead-in study.
Exclusion Criteria
2. 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:
1. At the Screening/Baseline Visit, the patient scores "yes" on Suicidal Ideation Items 4 or 5 of the C SSRS "Since Last Visit" version;
2. At the Screening/Baseline visit, the patient scores ≥ 5 on the MADRS Item 10 (Suicidal Thoughts).
3. 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.
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
Phoenix, Arizona, United States
Clinical Site
Bentonville, Arkansas, United States
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Little Rock, Arkansas, United States
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Rogers, Arkansas, United States
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Culver City, California, United States
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Glendale, California, United States
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Newport Beach, California, United States
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Oceanside, California, United States
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Redlands, California, United States
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Riverside, California, United States
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San Diego, California, United States
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Sherman Oaks, California, United States
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Temecula, California, United States
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Upland, California, United States
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Fort Lauderdale, Florida, United States
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Jacksonville, Florida, United States
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Orlando, Florida, United States
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Palm Bay, Florida, United States
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West Palm Beach, Florida, United States
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Atlanta, Georgia, United States
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Atlanta, Georgia, United States
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Atlanta, Georgia, United States
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Decatur, Georgia, United States
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Joliet, Illinois, United States
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Overland Park, Kansas, United States
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Gaithersburg, Maryland, United States
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Boston, Massachusetts, United States
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Flowood, Mississippi, United States
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Saint Charles, Missouri, United States
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Berlin, New Jersey, United States
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Toms River, New Jersey, United States
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Brooklyn, New York, United States
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Cedarhurst, New York, United States
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Mount Kisco, New York, United States
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Charlotte, North Carolina, United States
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Allentown, Pennsylvania, United States
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Media, Pennsylvania, United States
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Plymouth Meeting, Pennsylvania, United States
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Austin, Texas, United States
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Bellevue, Washington, United States
Clinical Site
Burgas, , Bulgaria
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Kazanlak, , Bulgaria
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Novi Iskar, , Bulgaria
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Pleven, , Bulgaria
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Plovdiv, , Bulgaria
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Rousse, , Bulgaria
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Sofia, , Bulgaria
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Sofia, , Bulgaria
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Targovishte, , Bulgaria
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Tsarev Brod, , Bulgaria
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Veliko Tarnovo, , Bulgaria
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Veliko Tarnovo, , Bulgaria
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Vratsa, , Bulgaria
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Brno, , Czechia
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Brno, , Czechia
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Hostivice, , Czechia
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Ostrava, , Czechia
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Pilsen, , Czechia
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Prague, , Czechia
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Prague, , Czechia
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Prague, , Czechia
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Helsinki, , Finland
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Oulu, , Finland
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Bad Homburg, , Germany
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Freiburg im Breisgau, , Germany
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Hamburg, , Germany
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Mittweida, , Germany
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Schwerin, , Germany
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Westerstede, , Germany
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Budapest, , Hungary
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Budapest, , Hungary
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Budapest, , Hungary
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Budapest, , Hungary
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Debrecen, , Hungary
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Gyöngyös, , Hungary
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Guwahati, Assam, India
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Ahmedabad, Gujarat, India
Clinical Site
Jūnāgadh, Gujarat, India
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Vadodara, Gujarat, India
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Mysore, Karnataka, India
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Aurangabad, Maharashtra, India
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Nagpur, Maharashtra, India
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Nashik, Maharashtra, India
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Mumbai, , India
Clinical Site
Nashik, , India
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Bełchatów, , Poland
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Bialystok, , Poland
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Bialystok, , Poland
Clinical Site
Bialystok, , Poland
Clinical Site
Bydgoszcz, , Poland
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Gdansk, , Poland
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Gorlice, , Poland
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Leszno, , Poland
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Pruszcz Gdański, , Poland
Clinical SIte
Torun, , Poland
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Wroclaw, , Poland
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Bratislava, , Slovakia
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Košice, , Slovakia
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Rimavská Sobota, , Slovakia
Clinical Site
Svidník, , Slovakia
Clinical Site
Vranov nad Topľou, , Slovakia
Clinical Site
Zlaté Moravce, , Slovakia
Clinical Site
Ansan-si, North Chungcheong, South Korea
Clinical Site
Gwangju, , South Korea
Clinical Site
Seoul, , South Korea
Clinical Site
Seoul, , South Korea
Clinical Site
Seoul, , South Korea
Clinical Site
Lund, , Sweden
Clinical Site
Stockholm, , Sweden
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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ITI-007-503
Identifier Type: -
Identifier Source: org_study_id
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