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NCT05061706 · ClinicalTrials.gov registry record · Phase 3
Multicenter Study of Lumateperone as Adjunctive Therapy in the Treatment of Patients With Major Depressive Disorder
A Phase 3 study, sponsored by Intra-Cellular Therapies.
- Completed
- Registry status
- Phase 3
- Development phase
- 480
- Enrollment target
NCT05061706 is a Phase 3 study that has completed, run by Intra-Cellular Therapies. The registered enrollment target is 480 participants.
The verdict
NCT05061706, a Phase 3 study, has completed, sponsored by Intra-Cellular Therapies.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 480 participants
- Enrollment target
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.
Interventions
- DRUG Placebo
- DRUG Lumateperone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 480 participants |
| Start Date | 2021-09-30 |
| Est. Completion | 2024-04-12 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05061706
The ClinicalTrials.gov registry entry for NCT05061706 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 480 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Intra-Cellular Therapies, which has 37 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT05061706 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05061706 about?
NCT05061706 is a clinical study titled "Multicenter 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 NCT05061706?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 480 participants. The study started on 2021-09-30. Estimated completion is 2024-04-12.
What interventions are being tested in trial NCT05061706?
The interventions under investigation include: Placebo (DRUG), Lumateperone (DRUG).
Who is sponsoring clinical trial NCT05061706?
This trial is sponsored by Intra-Cellular Therapies, which has 37 total clinical trials registered on ClinicalTrials.gov.
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