Lumateperone Monotherapy for the Treatment of Bipolar Depression Conducted Globally
Public ClinicalTrials.gov record NCT03249376. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Assess 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) Conducted Globally
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT03249376
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 381 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 75 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Nov 27, 2017 (Actual)
- Primary completion
- Mar 1, 2019 (Actual)
- Completion
- Mar 1, 2019 (Actual)
- Last update posted
- Jun 3, 2022
2017 – 2019
United States locations
- U.S. sites
- 14
- U.S. states
- 11
- U.S. cities
- 14
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Clinical Site | Birmingham | Alabama | 35294 | — |
| Clinical Site | Sherman Oaks | California | 91403 | — |
| Clinical Site | Miami | Florida | 33133 | — |
| Clinical Site | Orange City | Florida | 32763 | — |
| Clinical Site | Atlanta | Georgia | 30322 | — |
| Clinical Site | Decatur | Georgia | 30030 | — |
| Clinical Site | Chicago | Illinois | 60612 | — |
| Clinical Site | Joliet | Illinois | 60435 | — |
| Clinical Site | Shreveport | Louisiana | 71101 | — |
| Clinical Site | St Louis | Missouri | 63128 | — |
| Clinical Site | Buffalo | New York | 14215 | — |
| Clinical Site | Charlotte | North Carolina | 28211 | — |
| Clinical Site | The Woodlands | Texas | 77381 | — |
| Clinical Site | Bothell | Washington | 98011 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 33 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03249376, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jun 3, 2022 · Synced Oct 21, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03249376 live on ClinicalTrials.gov.