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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 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.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05061719
The ClinicalTrials.gov registry entry for NCT05061719 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 812 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 374-participant average among 282 other Major Depressive Disorder trials with a reported enrollment target (117% higher). The listed sponsor is Intra-Cellular Therapies, which has 37 total studies on file at ClinicalTrials.gov.
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 reports 20 study locations spanning 5 distinct geographic areas - top geographies include 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.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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