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NCT04985942 · ClinicalTrials.gov registry record · Phase 3
Clinical Trial 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
- 485
- Enrollment target
- 20
- Study locations
NCT04985942 is a Phase 3 study of Major Depressive Disorder that has completed, run by Intra-Cellular Therapies. The registered enrollment target is 485 participants, above the 375-participant average among 282 other Major Depressive Disorder trials with a reported enrollment target (29% higher). The trial reports 20 study locations across 9 states.
The verdict
NCT04985942, a Phase 3 study of Major Depressive Disorder, has completed, sponsored by Intra-Cellular Therapies.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 485 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)
California
- Clinical Site - Glendale
- Clinical Site - Oceanside
- Clinical Site - Redlands
- Clinical Site - Temecula
- Clinical Site - Upland
Other
- Clinical Site - Burgas
- Clinical Site - Kazanlak
- Clinical Site - Pleven
- Clinical Site - Rousse
- Clinical Site - Tsarev Brod
Florida
- Clinical Site - Fort Lauderdale
- Clinical Site - Jacksonville
- Clinical Site - Orlando
New Jersey
- Clinical Site - Berlin
- Clinical Site - Toms River
Arizona
- Clinical Site - Phoenix
Georgia
- Clinical Site - Decatur
Massachusetts
- Clinical Site - Boston
New York
- Clinical Site - Cedarhurst
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 485 participants |
| Start Date | 2021-07-30 |
| Est. Completion | 2024-02-27 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04985942
The ClinicalTrials.gov registry entry for NCT04985942 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 485 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 (29% 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.
NCT04985942 reports 20 study locations spanning 9 distinct geographic areas - top geographies include California, Other, Florida.
Frequently Asked Questions
What is clinical trial NCT04985942 about?
NCT04985942 is a clinical study titled "Clinical Trial 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 NCT04985942?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 485 participants. The study started on 2021-07-30. Estimated completion is 2024-02-27.
What conditions does trial NCT04985942 study?
This clinical trial studies the following conditions: Major Depressive Disorder.
What interventions are being tested in trial NCT04985942?
The interventions under investigation include: Placebo (DRUG), Lumateperone (DRUG).
Who is sponsoring clinical trial NCT04985942?
This trial is sponsored by Intra-Cellular Therapies, which has 37 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04985942 being conducted?
This trial has 20 study locations across Arizona, California, Florida, Georgia, Massachusetts. 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.