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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: Completed Phase 3 study of Bipolar Depression, sponsored by Intra-Cellular Therapies.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The Montgomery-Åsberg Depression Rating Scale (MADRS) 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.
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 |
What the finished NCT03249376 record still lists
NCT03249376 is an interventional study that assigns participants to a tested intervention. The registered 381 participants enrollment target is mid-sized for trials with a published cap, above the 203-participant average among 29 other Bipolar Depression trials with a reported enrollment target (88% higher).
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 names 20 study sites across 12 states, led by 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
Similar trials for Bipolar Depression
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03249376's enrollment target sits among peer trials
381 8th of 29 higher than 22 of 29 other Bipolar Depression trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Bipolar Depression 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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Pediatric Open-Label Extension Study
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Clinical Trial Evaluating ITI-007 (Lumateperone) as a Monotherapy for the Treatment of Bipolar Depression
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-
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