NCT05061719CompletedPhase 3
An Open-label Study of Lumateperone as Adjunctive Therapy in the Treatment of Patients With Major Depressive Disorder
An Open-label, Multicenter Trial to Assess the Safety and Tolerability of Lumateperone as Adjunctive Therapy in the Treatment of Patients With Major Depressive Disorder
Source: ClinicalTrials.gov · Last updated 3 Nov 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 812 (actual)
- First submitted
- 20 Sept 2021
- Start date
- 8 Oct 2021
- Primary completion date
- 14 Oct 2024
- Lead sponsor
- Intra-Cellular Therapies, Inc.
- Diseases
- Depression
- NCT number
- NCT05061719
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 812
- From 8 Oct 2021 to the primary completion date, 14 Oct 2024
- 94 sites in 11 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Lab values
- 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.
Other
- 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).
Who the study is looking for
- 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.
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (94)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Clinical Site Coordinator of this site? Confirm its status | Burgas | Bulgaria | Unknown status |
| Clinical Site Coordinator of this site? Confirm its status | Kazanlak | Bulgaria | Unknown status |
| Clinical Site Coordinator of this site? Confirm its status | Novi Iskar | Bulgaria | Unknown status |
| Clinical Site Coordinator of this site? Confirm its status | Pleven | Bulgaria | Unknown status |
| Clinical Site Coordinator of this site? Confirm its status | Plovdiv | Bulgaria | Unknown status |
| Clinical Site Coordinator of this site? Confirm its status | Rousse | Bulgaria | Unknown status |
| Clinical Site Coordinator of this site? Confirm its status | Sofia | Bulgaria | Unknown status |
| Clinical Site Coordinator of this site? Confirm its status | Targovishte | Bulgaria | Unknown status |
| Clinical Site Coordinator of this site? Confirm its status | Tsarev Brod | Bulgaria | Unknown status |
| Clinical Site Coordinator of this site? Confirm its status | Veliko Tarnovo | Bulgaria | Unknown status |
| Clinical Site Coordinator of this site? Confirm its status | Vratsa | Bulgaria | Unknown status |
| Clinical Site Coordinator of this site? Confirm its status | Brno | Czechia | Unknown status |
| Clinical Site Coordinator of this site? Confirm its status | Hostivice | Czechia | Unknown status |
| Clinical Site Coordinator of this site? Confirm its status | Ostrava | Czechia | Unknown status |
| Clinical site Coordinator of this site? Confirm its status | Pilsen | Czechia | Unknown status |
| Clinical Site Coordinator of this site? Confirm its status | Prague | Czechia | Unknown status |
| Clinical Site Coordinator of this site? Confirm its status | Bad Homburg | Germany | Unknown status |
| Clinical site Coordinator of this site? Confirm its status | Freiburg im Breisgau | Germany | Unknown status |
| Clinical Site Coordinator of this site? Confirm its status | Hamburg | Germany | Unknown status |
| Clinical Site Coordinator of this site? Confirm its status | Mittweida | Germany | Unknown status |
| Clinical Site Coordinator of this site? Confirm its status | Schwerin | Germany | Unknown status |
| Clinical Site Coordinator of this site? Confirm its status | Westerstede | Germany | Unknown status |
| Clinical Site Coordinator of this site? Confirm its status | Helsinki | Finland | Unknown status |
| Clinical Site Coordinator of this site? Confirm its status | Oulu | Finland | Unknown status |
| Clinical Site Coordinator of this site? Confirm its status | Budapest | Hungary | Unknown status |
| Clinical Site Coordinator of this site? Confirm its status | Debrecen | Hungary | Unknown status |
| Clinical Site Coordinator of this site? Confirm its status | Gyöngyös | Hungary | Unknown status |
| Clinical Site Coordinator of this site? Confirm its status | Ahmedabad | India | Unknown status |
| Clinical Site Coordinator of this site? Confirm its status | Chhatrapati Sambhajinagar | India | Unknown status |
| Clinical Site Coordinator of this site? Confirm its status | Guwahati | India | Unknown status |
| Clinical Site Coordinator of this site? Confirm its status | Jūnāgadh | India | Unknown status |
| Clinical Site Coordinator of this site? Confirm its status | Mumbai | India | Unknown status |
| Clinical Site Coordinator of this site? Confirm its status | Mysore | India | Unknown status |
| Clinical Site Coordinator of this site? Confirm its status | Nagpur | India | Unknown status |
| Clinical Site Coordinator of this site? Confirm its status | Nashik | India | Unknown status |
| Clinical Site Coordinator of this site? Confirm its status | Vadodara | India | Unknown status |
| Clinical Site Coordinator of this site? Confirm its status | Ansan-si | South Korea | Unknown status |
| Clinical Site Coordinator of this site? Confirm its status | Gwangju | South Korea | Unknown status |
| Clinical Site Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Clinical Site Coordinator of this site? Confirm its status | Bełchatów | Poland | Unknown status |
| Clinical Site Coordinator of this site? Confirm its status | Bialystok | Poland | Unknown status |
| Clinical Site Coordinator of this site? Confirm its status | Bydgoszcz | Poland | Unknown status |
| Clinical Site Coordinator of this site? Confirm its status | Gdansk | Poland | Unknown status |
| Clinical Site Coordinator of this site? Confirm its status | Gorlice | Poland | Unknown status |
| Clinical Site Coordinator of this site? Confirm its status | Leszno | Poland | Unknown status |
| Clinical Site Coordinator of this site? Confirm its status | Pruszcz Gdański | Poland | Unknown status |
| Clinical Site Coordinator of this site? Confirm its status | Torun | Poland | Unknown status |
| Clinical Site Coordinator of this site? Confirm its status | Wroclaw | Poland | Unknown status |
| Clinical Site Coordinator of this site? Confirm its status | Lund | Sweden | Unknown status |
| Clinical Site Coordinator of this site? Confirm its status | Stockholm | Sweden | Unknown status |
| Clinical Site Coordinator of this site? Confirm its status | Bratislava | Slovakia | Unknown status |
| Clinical Site Coordinator of this site? Confirm its status | Košice | Slovakia | Unknown status |
| Clinical Site Coordinator of this site? Confirm its status | Rimavská Sobota | Slovakia | Unknown status |
| Clinical Site Coordinator of this site? Confirm its status | Svidník | Slovakia | Unknown status |
| Clinical Site Coordinator of this site? Confirm its status | Vranov nad Topľou | Slovakia | Unknown status |
| Clinical Site Coordinator of this site? Confirm its status | Zlaté Moravce | Slovakia | Unknown status |
| Clinical Site Coordinator of this site? Confirm its status | Allentown | United States | Unknown status |
| Clinical Site Coordinator of this site? Confirm its status | Atlanta | United States | Unknown status |
| Clinical Site Coordinator of this site? Confirm its status | Austin | United States | Unknown status |
| Clinical Site Coordinator of this site? Confirm its status | Bellevue | United States | Unknown status |
| Clinical Site Coordinator of this site? Confirm its status | Bentonville | United States | Unknown status |
| Clinical Site Coordinator of this site? Confirm its status | Berlin | United States | Unknown status |
| Clinical Site Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| Clinical Site Coordinator of this site? Confirm its status | Brooklyn | United States | Unknown status |
| Clinical Site Coordinator of this site? Confirm its status | Cedarhurst | United States | Unknown status |
| Clinical Site Coordinator of this site? Confirm its status | Charlotte | United States | Unknown status |
| Clinical Site Coordinator of this site? Confirm its status | Culver City | United States | Unknown status |
| Clinical Site Coordinator of this site? Confirm its status | Decatur | United States | Unknown status |
| Clinical Site Coordinator of this site? Confirm its status | Flowood | United States | Unknown status |
| Clinical Site Coordinator of this site? Confirm its status | Fort Lauderdale | United States | Unknown status |
| Clinical Site Coordinator of this site? Confirm its status | Gaithersburg | United States | Unknown status |
| Clinical Site Coordinator of this site? Confirm its status | Glendale | United States | Unknown status |
| Clinical Site Coordinator of this site? Confirm its status | Jacksonville | United States | Unknown status |
| Clinical Site Coordinator of this site? Confirm its status | Joliet | United States | Unknown status |
| Clinical Site Coordinator of this site? Confirm its status | Little Rock | United States | Unknown status |
| Clinical Site Coordinator of this site? Confirm its status | Media | United States | Unknown status |
| Clinical Site Coordinator of this site? Confirm its status | Mount Kisco | United States | Unknown status |
| Clinical Site Coordinator of this site? Confirm its status | Newport Beach | United States | Unknown status |
| Clinical Site Coordinator of this site? Confirm its status | Oceanside | United States | Unknown status |
| Clinical Site Coordinator of this site? Confirm its status | Orlando | United States | Unknown status |
| Clinical Site Coordinator of this site? Confirm its status | Overland Park | United States | Unknown status |
| Clinical Site Coordinator of this site? Confirm its status | Palm Bay | United States | Unknown status |
| Clinical Site Coordinator of this site? Confirm its status | Phoenix | United States | Unknown status |
| Clinical Site Coordinator of this site? Confirm its status | Plymouth Meeting | United States | Unknown status |
| Clinical Site Coordinator of this site? Confirm its status | Redlands | United States | Unknown status |
| Clinical Site Coordinator of this site? Confirm its status | Riverside | United States | Unknown status |
| Clinical Site Coordinator of this site? Confirm its status | Rogers | United States | Unknown status |
| Clinical Site Coordinator of this site? Confirm its status | Saint Charles | United States | Unknown status |
| Clinical Site Coordinator of this site? Confirm its status | San Diego | United States | Unknown status |
| Clinical Site Coordinator of this site? Confirm its status | Sherman Oaks | United States | Unknown status |
| Clinical Site Coordinator of this site? Confirm its status | Temecula | United States | Unknown status |
| Clinical Site Coordinator of this site? Confirm its status | Toms River | United States | Unknown status |
| Clinical Site Coordinator of this site? Confirm its status | Upland | United States | Unknown status |
| Clinical Site Coordinator of this site? Confirm its status | West Palm Beach | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.