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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: Completed Phase 3 study, sponsored by Intra-Cellular Therapies.
NCT04285515 is a Phase 3 study that has completed, run by Intra-Cellular Therapies. The registered enrollment target is 488 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (37% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The Montgomery-Åsberg Depression Rating Scale is a clinician-rated 10 item scale to assess depressive symptoms. Each item is rated on a 7-point scale from 0-6. The total score ranges from 0 to 60 with a higher score indicating increased severity of depressive symptoms.
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 |
What the finished NCT04285515 record still lists
NCT04285515 is an interventional study that assigns participants to a tested intervention. The registered 488 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (37% lower).
The record links to 0 conditions, and to 2 interventions - of which Lumateperone is the first listed.
NCT04285515 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04285515's enrollment target sits among peer trials
488 784th of 2000 higher than 1,215 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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