An Open-label Study of Lumateperone as Adjunctive Therapy in the Treatment of Patients With Major Depressive Disorder
Launched by INTRA-CELLULAR THERAPIES, INC. · Sep 20, 2021
Trial Information
Current as of June 17, 2025
Completed
Keywords
ClinConnect Summary
At the Screening/Baseline Visit (Visit 1/Day 1), which is the same visit as Visit 8/Day 43 of the lead-in study, eligible patients will receive open-label lumateperone 42 mg once daily for approximately 26 weeks. Patients will continue their background ADT from the lead-in study. Patients will be seen for weekly visits through Visit 5/Week 4. Thereafter, visits will occur every two weeks. A Safety Follow-up visit will occur on Visit 17/Day 197, approximately 2 weeks after the last dose of open-label lumateperone 42 mg.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • 1. In the opinion of the Investigator, patients must have safely completed the lead-in study.
- • 2. Patient is taking their ADT as prescribed from the lead-in study.
- Exclusion Criteria:
- • 1. In the opinion of the Investigator, the patient is unable to comply with study procedures or judged to be inappropriate for the study.
- 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.
About Intra Cellular Therapies, Inc.
Intra-Cellular Therapies, Inc. is a biopharmaceutical company dedicated to the development of innovative therapies for neuropsychiatric and other central nervous system disorders. The company focuses on leveraging its proprietary technologies to explore novel mechanisms of action, aiming to address unmet medical needs in complex conditions such as schizophrenia, bipolar disorder, and depression. Intra-Cellular Therapies is committed to advancing clinical research and improving patient outcomes through rigorous scientific inquiry, robust clinical trials, and a patient-centered approach to drug development.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
San Diego, California, United States
Glendale, California, United States
Sherman Oaks, California, United States
Decatur, Georgia, United States
Joliet, Illinois, United States
Charlotte, North Carolina, United States
Rogers, Arkansas, United States
Newport Beach, California, United States
Oceanside, California, United States
Bellevue, Washington, United States
Plovdiv, , Bulgaria
Ruse, , Bulgaria
Sofia, , Bulgaria
Veliko Tarnovo, , Bulgaria
Little Rock, Arkansas, United States
Culver City, California, United States
Berlin, New Jersey, United States
Kazanlak, , Bulgaria
Novi Iskar, , Bulgaria
Targovishte, , Bulgaria
Phoenix, Arizona, United States
Bentonville, Arkansas, United States
Redlands, California, United States
Upland, California, United States
Fort Lauderdale, Florida, United States
Jacksonville, Florida, United States
Orlando, Florida, United States
Boston, Massachusetts, United States
Toms River, New Jersey, United States
Austin, Texas, United States
Burgas, , Bulgaria
Pleven, , Bulgaria
Tsarev Brod, , Bulgaria
Vratsa, , Bulgaria
Brno, , Czechia
Bratislava, , Slovakia
Vranov Nad Topľou, , Slovakia
Riverside, California, United States
Palm Bay, Florida, United States
West Palm Beach, Florida, United States
Atlanta, Georgia, United States
Overland Park, Kansas, United States
Gaithersburg, Maryland, United States
Flowood, Mississippi, United States
Brooklyn, New York, United States
Allentown, Pennsylvania, United States
Media, Pennsylvania, United States
Plymouth Meeting, Pennsylvania, United States
Temecula, California, United States
Hostivice, , Czechia
Plzen, , Czechia
Prague, , Czechia
Budapest, , Hungary
Debrecen, , Hungary
Gyöngyös, , Hungary
Košice, , Slovakia
Rimavská Sobota, , Slovakia
Svidník, , Slovakia
Zlaté Moravce, , Slovakia
Bad Homburg, , Germany
Freiburg Im Breisgau, , Germany
Hamburg, , Germany
Mittweida, , Germany
Schwerin, , Germany
Westerstede, , Germany
Białystok, , Poland
Bydgoszcz, , Poland
Gdańsk, , Poland
Gorlice, , Poland
Leszno, , Poland
Pruszcz Gdański, , Poland
Toruń, , Poland
Wrocław, , Poland
Saint Charles, Missouri, United States
Cedarhurst, New York, United States
Mount Kisco, New York, United States
Ostrava, , Czechia
Belchatow, , Poland
Guwahati, Assam, India
Ahmedabad, Gujarat, India
Vadodara, Gujarat, India
Mysore, Karnataka, India
Aurangabad, Maharashtra, India
Nagpur, Maharashtra, India
Nashik, Maharashtra, India
Gwangju, , Korea, Republic Of
Seoul, , Korea, Republic Of
Helsinki, , Finland
Oulu, , Finland
Lund, , Sweden
Stockholm, , Sweden
Jūnāgadh, Gujarat, India
Mumbai, , India
Ansan Si, Chungcheongbuk Do, Korea, Republic Of
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
Similar Trials