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NCT05061719 · ClinicalTrials.gov registry record · Phase 3
An Open-label Study of Lumateperone as Adjunctive Therapy in the Treatment of Patients With Major Depressive Disorder
A Phase 3 study of Major Depressive Disorder, sponsored by Intra-Cellular Therapies.
- Completed
- Registry status
- Phase 3
- Development phase
- 812
- Enrollment target
- 20
- Study locations
NCT05061719: Completed Phase 3 study of Major Depressive Disorder, sponsored by Intra-Cellular Therapies.
NCT05061719 is a Phase 3 study of Major Depressive Disorder that has completed, run by Intra-Cellular Therapies. The registered enrollment target is 812 participants, above the 374-participant average among 282 other Major Depressive Disorder trials with a reported enrollment target (117% higher). The trial reports 20 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05061719, a Phase 3 study of Major Depressive Disorder, has completed, sponsored by Intra-Cellular Therapies.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 812 participants
- Enrollment target
- 20
- Study locations
Study 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.
Primary Outcome
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.
Conditions Studied
Interventions
- DRUG Lumateperone
Study Locations (20)
California
- Clinical Site - Culver City
- Clinical Site - Glendale
- Clinical Site - Newport Beach
- Clinical Site - Oceanside
- Clinical Site - Redlands
- Clinical Site - Riverside
- Clinical Site - San Diego
- Clinical Site - Sherman Oaks
- Clinical Site - Temecula
- Clinical Site - Upland
Florida
- Clinical Site - Fort Lauderdale
- Clinical Site - Jacksonville
- Clinical Site - Orlando
- Clinical Site - Palm Bay
- Clinical Site - West Palm Beach
Arkansas
- Clinical Site - Bentonville
- Clinical Site - Little Rock
- Clinical Site - Rogers
Arizona
- Clinical Site - Phoenix
Georgia
- Clinical Site - Atlanta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 812 participants |
| Start Date | 2021-10-08 |
| Est. Completion | 2024-10-23 |
| Phase | Phase 3 |
What the finished NCT05061719 record still lists
NCT05061719 is an interventional study that assigns participants to a tested intervention. The registered 812 participants enrollment target is mid-sized for trials with a published cap, above the 374-participant average among 282 other Major Depressive Disorder trials with a reported enrollment target (117% higher).
The record links to 1 condition, with Major Depressive Disorder appearing as the primary indexed condition, and to 1 intervention - of which Lumateperone is the first listed.
NCT05061719 names 20 study sites across 5 states, led by California, Florida, Arkansas.
Frequently Asked Questions
What is clinical trial NCT05061719 about?
NCT05061719 is a clinical study titled "An Open-label Study of Lumateperone as Adjunctive Therapy in the Treatment of Patients With Major Depressive Disorder". 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.
What is the current status of trial NCT05061719?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 812 participants. The study started on 2021-10-08. Estimated completion is 2024-10-23.
What conditions does trial NCT05061719 study?
This clinical trial studies the following conditions: Major Depressive Disorder.
What interventions are being tested in trial NCT05061719?
The interventions under investigation include: Lumateperone (DRUG).
Who is sponsoring clinical trial NCT05061719?
This trial is sponsored by Intra-Cellular Therapies, which has 37 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05061719 being conducted?
This trial has 20 study locations across Arizona, Arkansas, California, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Major Depressive Disorder
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05061719's enrollment target sits among peer trials
812 13th of 282 higher than 270 of 282 other Major Depressive Disorder trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Major Depressive Disorder trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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