Clinical Trial Evaluating ITI-007 (Lumateperone) as a Monotherapy for the Treatment of Bipolar Depression
Public ClinicalTrials.gov record NCT02600494. 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 With an Open-Label Extension to Assess the Efficacy and Safety of ITI-007 Monotherapy in the Treatment of Patients With Major Depressive Episodes Associated With Bipolar I or Bipolar II Disorder (Bipolar Depression)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The study will evaluate the efficacy and safety of ITI-007 (Lumateperone) in patients diagnosed with Bipolar I or Bipolar II disorder having a major depressive episode. The study will be conducted in two parts, Part A and Part B. Part A is a randomized, double-blind, placebo-controlled study. In Part B, patients who safely complete participation in part A may be enrolled in an open-label extension.
Study identification
- NCT ID
- NCT02600494
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 554 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
- Dec 15, 2015 (Actual)
- Primary completion
- Jan 28, 2019 (Actual)
- Completion
- Jul 24, 2019 (Actual)
- Last update posted
- Nov 3, 2025
2015 – 2019
United States locations
- U.S. sites
- 55
- U.S. states
- 20
- U.S. cities
- 55
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Clinical Site | Little Rock | Arkansas | — | — |
| Clinical Site | Rogers | Arkansas | — | — |
| Clinical Site | Cerritos | California | — | — |
| Clinical Site | Culver City | California | — | — |
| Clinical Site | Garden Grove | California | — | — |
| Clinical Site | Lemon Grove | California | — | — |
| Clinical Site | National City | California | — | — |
| Clinical Site | Oakland | California | — | — |
| Clinical Site | Oceanside | California | — | — |
| Clinical Site | Orange | California | — | — |
| Clinical Site | Pico Rivera | California | — | — |
| Clinical Site | Riverside | California | — | — |
| Clinical Site | San Diego | California | — | — |
| Clinical Site | San Marcos | California | — | — |
| Clinical Site | Santa Rosa | California | — | — |
| Clinical Site | Colorado Springs | Colorado | — | — |
| Clinical Site | Bradenton | Florida | — | — |
| Clinical Site | Fort Myers | Florida | — | — |
| Clinical Site | Jacksonville | Florida | — | — |
| Clinical Site | Lauderhill | Florida | — | — |
| Clinical Site | Miami | Florida | — | — |
| Clinical Site | North Miami | Florida | — | — |
| Clinical Site | Orlando | Florida | — | — |
| Clinical Site | Atlanta | Georgia | — | — |
| Clinical Site | Chicago | Illinois | — | — |
| Clinical Site | Hoffman Estates | Illinois | — | — |
| Clinical Site | Lake Charles | Louisiana | — | — |
| Clinical Site | Baltimore | Maryland | — | — |
| Clinical Site | Boston | Massachusetts | — | — |
| Clinical Site | O'Fallon | Missouri | — | — |
| Clinical Site | St Louis | Missouri | — | — |
| Clinical Site | Las Vegas | Nevada | — | — |
| Clinical Site | Berlin | New Jersey | — | — |
| Clinical Site | Cherry Hill | New Jersey | — | — |
| Clinical Site | Marlton | New Jersey | — | — |
| Clinical Site | Toms River | New Jersey | — | — |
| Clinical Site | Brooklyn | New York | — | — |
| Clinical Site | Cedarhurst | New York | — | — |
| Clinical Site | New York | New York | — | — |
| Clinical Site | Rochester | New York | — | — |
| Clinical Site | Staten Island | New York | — | — |
| Clinical Site | Cincinnati | Ohio | — | — |
| Clinical Site | Cleveland | Ohio | — | — |
| Clinical Site | Dayton | Ohio | — | — |
| Clinical Site | Garfield Heights | Ohio | — | — |
| Clinical Site | Oklahoma City | Oklahoma | — | — |
| Clinical Site | Allentown | Pennsylvania | — | — |
| Clinical Site | Norristown | Pennsylvania | — | — |
| Clinical Site | Philadelphia | Pennsylvania | — | — |
| Clinical Site | Memphis | Tennessee | — | — |
| Clinical Site | Austin | Texas | — | — |
| Clinical Site | Dallas | Texas | — | — |
| Clinical Site | Houston | Texas | — | — |
| Clinical Site | Petersburg | Virginia | — | — |
| Clinical Site | Everett | Washington | — | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02600494, 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 Nov 3, 2025 · 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 NCT02600494 live on ClinicalTrials.gov.