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NCT04285515 · ClinicalTrials.gov registry record · Phase 3
Clinical Trial Evaluating Lumateperone Monotherapy in the Treatment of Bipolar Depression or Major Depressive Disorder
A Phase 3 study, sponsored by Intra-Cellular Therapies.
- Completed
- Registry status
- Phase 3
- Development phase
- 488
- Enrollment target
NCT04285515 is a Phase 3 study that has completed, run by Intra-Cellular Therapies. The registered enrollment target is 488 participants.
The verdict
NCT04285515, a Phase 3 study, has completed, sponsored by Intra-Cellular Therapies.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 488 participants
- Enrollment target
Study Summary
This is a randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of lumateperone monotherapy in the treatment of patients with major depressive episodes associated with Bipolar I or Bipolar II Disorder (Bipolar Depression) or major depressive disorder (MDD) who also meet the Diagnostic and Statistical Manual of Mental Disorder, 5th Edition (DSM-5) criteria for mixed-features. The study consists of a Screening Period, a Double-blind Treatment Period, and a Safety Follow-up Period.
Interventions
- DRUG Lumateperone
- DRUG Placebos
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 488 participants |
| Start Date | 2020-02-27 |
| Est. Completion | 2022-11-30 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04285515
The ClinicalTrials.gov registry entry for NCT04285515 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 488 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 Lumateperone is the first listed.
NCT04285515 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04285515 about?
NCT04285515 is a clinical study titled "Clinical Trial Evaluating Lumateperone Monotherapy in the Treatment of Bipolar Depression or Major Depressive Disorder". This is a randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of lumateperone monotherapy in the treatment of patients with major depressive episodes associated with Bipolar I or Bipolar II Disorder (Bipolar Depression) or major depressive disorder (MD...
What is the current status of trial NCT04285515?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 488 participants. The study started on 2020-02-27. Estimated completion is 2022-11-30.
What interventions are being tested in trial NCT04285515?
The interventions under investigation include: Lumateperone (DRUG), Placebos (DRUG).
Who is sponsoring clinical trial NCT04285515?
This trial is sponsored by Intra-Cellular Therapies, which has 37 total clinical trials registered on ClinicalTrials.gov.
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