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NCT05850689 · ClinicalTrials.gov registry record · Phase 3
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.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 470
- Enrollment target
- 20
- Study locations
NCT05850689 is a Phase 3 study of Major Depressive Disorder that is actively recruiting participants, run by Intra-Cellular Therapies. The registered enrollment target is 470 participants, above the 375-participant average among 282 other Major Depressive Disorder trials with a reported enrollment target (25% higher). The trial reports 20 study locations across 10 states.
The verdict
NCT05850689, a Phase 3 study of Major Depressive Disorder, is actively recruiting participants, sponsored by Intra-Cellular Therapies.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 470 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is a multicenter, randomized, double-blind, placebo-controlled parallel-group, fixed-dose study in patients with a primary diagnosis of MDD according to criteria of the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) who have an inadequate response to ongoing ADT.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Lumateperone
Study Locations (20)
Florida
- Clinical Site - Clermont
- Clinical Site - Hialeah
- Clinical Site - Miami
- Clinical Site - Miami
- Clinical Site - Miami
- Clinical Site - Tampa
Kansas
- Clinical Site - Kansas City
- Clinical Site - Kansas City
- Clinical Site - Overland Park
Ohio
- Clinical Site - Avon Lake
- Clinical Site - Cincinnati
- Clinical Site - Columbus
Georgia
- Clinical Site - Atlanta
- Clinical Site - Decatur
Alabama
- Clinical Site - Huntsville
California
- Clinical Site - Pico Rivera
Connecticut
- Clinical Site - Farmington
Massachusetts
- Clinical Site - Methuen
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 470 participants |
| Start Date | 2023-05-02 |
| Est. Completion | 2026-10 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05850689
The ClinicalTrials.gov registry entry for NCT05850689 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 470 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 375-participant average among 282 other Major Depressive Disorder trials with a reported enrollment target (25% 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 2 interventions - of which Placebo is the first listed.
NCT05850689 reports 20 study locations spanning 10 distinct geographic areas - top geographies include Florida, Kansas, Ohio.
Frequently Asked Questions
What is clinical trial NCT05850689 about?
NCT05850689 is a clinical study titled "Study of Lumateperone as Adjunctive Therapy in the Treatment of Patients With Major Depressive Disorder". This is a multicenter, randomized, double-blind, placebo-controlled parallel-group, fixed-dose study in patients with a primary diagnosis of MDD according to criteria of the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) who have an inadequate response to ongoing ADT.
What is the current status of trial NCT05850689?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 470 participants. The study started on 2023-05-02. Estimated completion is 2026-10.
What conditions does trial NCT05850689 study?
This clinical trial studies the following conditions: Major Depressive Disorder.
What interventions are being tested in trial NCT05850689?
The interventions under investigation include: Placebo (DRUG), Lumateperone (DRUG).
Who is sponsoring clinical trial NCT05850689?
This trial is sponsored by Intra-Cellular Therapies, which has 37 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05850689 being conducted?
This trial has 20 study locations across Alabama, California, Connecticut, 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
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.