An Open-label Study of Lumateperone as Adjunctive Therapy in the Treatment of Patients With Major Depressive Disorder
Public ClinicalTrials.gov record NCT05061719. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT05061719
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 812 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 65 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Oct 7, 2021
- Primary completion
- Oct 13, 2024
- Completion
- Oct 22, 2024
- Last update posted
- Nov 2, 2025
2021 – 2024
United States locations
- U.S. sites
- 40
- U.S. states
- 17
- U.S. cities
- 38
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Clinical Site | Phoenix | Arizona | 85012 | — |
| Clinical Site | Bentonville | Arkansas | 72712 | — |
| Clinical Site | Little Rock | Arkansas | 72211 | — |
| Clinical Site | Rogers | Arkansas | 72758 | — |
| Clinical Site | Culver City | California | 90230 | — |
| Clinical Site | Glendale | California | 91206 | — |
| Clinical Site | Newport Beach | California | 92660 | — |
| Clinical Site | Oceanside | California | 92056 | — |
| Clinical Site | Redlands | California | 92374 | — |
| Clinical Site | Riverside | California | 92506 | — |
| Clinical Site | San Diego | California | 92103 | — |
| Clinical Site | Sherman Oaks | California | 91403 | — |
| Clinical Site | Temecula | California | 92951 | — |
| Clinical Site | Upland | California | 91786 | — |
| Clinical Site | Fort Lauderdale | Florida | 33319 | — |
| Clinical Site | Jacksonville | Florida | 32256 | — |
| Clinical Site | Orlando | Florida | 32801 | — |
| Clinical Site | Palm Bay | Florida | 32905 | — |
| Clinical Site | West Palm Beach | Florida | 33407 | — |
| Clinical Site | Atlanta | Georgia | 30328 | — |
| Clinical Site | Atlanta | Georgia | 30329 | — |
| Clinical Site | Atlanta | Georgia | 30331 | — |
| Clinical Site | Decatur | Georgia | 30030 | — |
| Clinical Site | Joliet | Illinois | 60435 | — |
| Clinical Site | Overland Park | Kansas | 66211 | — |
| Clinical Site | Gaithersburg | Maryland | 20877 | — |
| Clinical Site | Boston | Massachusetts | 02131 | — |
| Clinical Site | Flowood | Mississippi | 39232 | — |
| Clinical Site | Saint Charles | Missouri | 63304 | — |
| Clinical Site | Berlin | New Jersey | 08009 | — |
| Clinical Site | Toms River | New Jersey | 08755 | — |
| Clinical Site | Brooklyn | New York | 11235 | — |
| Clinical Site | Cedarhurst | New York | 11516 | — |
| Clinical Site | Mount Kisco | New York | 10549 | — |
| Clinical Site | Charlotte | North Carolina | 28211 | — |
| Clinical Site | Allentown | Pennsylvania | 18104 | — |
| Clinical Site | Media | Pennsylvania | 19063 | — |
| Clinical Site | Plymouth Meeting | Pennsylvania | 19462 | — |
| Clinical Site | Austin | Texas | 78737 | — |
| Clinical Site | Bellevue | Washington | 98007 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 69 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05061719, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Nov 2, 2025 · Synced Sep 6, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete protocol, eligibility criteria, and contact information for NCT05061719 live on ClinicalTrials.gov.