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NCT03249376 · ClinicalTrials.gov registry record · Phase 3
Lumateperone Monotherapy for the Treatment of Bipolar Depression Conducted Globally
A Phase 3 study of Bipolar Depression, sponsored by Intra-Cellular Therapies.
- Completed
- Registry status
- Phase 3
- Development phase
- 381
- Enrollment target
- 20
- Study locations
NCT03249376 is a Phase 3 study of Bipolar Depression that has completed, run by Intra-Cellular Therapies. The registered enrollment target is 381 participants, above the 203-participant average among 29 other Bipolar Depression trials with a reported enrollment target (88% higher). The trial reports 20 study locations across 12 states.
The verdict
NCT03249376, a Phase 3 study of Bipolar Depression, has completed, sponsored by Intra-Cellular Therapies.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 381 participants
- Enrollment target
- 20
- Study locations
Study Summary
The study will evaluate the efficacy and safety of ITI-007 in a randomized, double-blind, parallel-group, placebo-controlled, multi-center study in patients diagnosed with Bipolar I or Bipolar II disorder having a major depressive episode.
Conditions Studied
Interventions
- OTHER Placebo
- DRUG Lumateperone
Study Locations (20)
Other
- Clinical Site - Burgas
- Clinical Site - Kardzhali
- Clinical Site - Lovech
- Clinical Site - Plovdiv
- Clinical Site - Rousse
- Clinical Site - Sofia
Florida
- Clinical Site - Miami
- Clinical Site - Orange City
Georgia
- Clinical Site - Atlanta
- Clinical Site - Decatur
Illinois
- Clinical Site - Chicago
- Clinical Site - Joliet
Alabama
- Clinical Site - Birmingham
California
- Clinical Site - Sherman Oaks
Louisiana
- Clinical Site - Shreveport
Missouri
- Clinical Site - St Louis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 381 participants |
| Start Date | 2017-11-27 |
| Est. Completion | 2019-03-01 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03249376
The ClinicalTrials.gov registry entry for NCT03249376 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 381 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 203-participant average among 29 other Bipolar Depression trials with a reported enrollment target (88% 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 Bipolar Depression appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT03249376 reports 20 study locations spanning 12 distinct geographic areas - top geographies include Other, Florida, Georgia.
Frequently Asked Questions
What is clinical trial NCT03249376 about?
NCT03249376 is a clinical study titled "Lumateperone Monotherapy for the Treatment of Bipolar Depression Conducted Globally". The study will evaluate the efficacy and safety of ITI-007 in a randomized, double-blind, parallel-group, placebo-controlled, multi-center study in patients diagnosed with Bipolar I or Bipolar II disorder having a major depressive episode.
What is the current status of trial NCT03249376?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 381 participants. The study started on 2017-11-27. Estimated completion is 2019-03-01.
What conditions does trial NCT03249376 study?
This clinical trial studies the following conditions: Bipolar Depression.
What interventions are being tested in trial NCT03249376?
The interventions under investigation include: Placebo (OTHER), Lumateperone (DRUG).
Who is sponsoring clinical trial NCT03249376?
This trial is sponsored by Intra-Cellular Therapies, which has 37 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03249376 being conducted?
This trial has 20 study locations across Alabama, California, Florida, Georgia, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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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.