Clinical trialNCT02600494CompletedPhase 3Interventional

Clinical Trial Evaluating ITI-007 (Lumateperone) as a Monotherapy for the Treatment of Bipolar Depression

SponsorIntra-Cellular Therapies, Inc.Enrollment554Bipolar Depression

View the registry record on ClinicalTrials.gov

Summary

The registered summary isn't in our current data snapshot. Read it on the ClinicalTrials.gov record ↗. Why? →

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

Susan Kozauer, MD
Intra-Cellular Therapies, Inc. (ITI)
Study Director
clinicaltrials.gov ↗

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

55 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States

Clinical Site
Little Rock, Arkansas, United States
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Rogers, Arkansas, United States
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Cerritos, California, United States
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Culver City, California, United States
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Garden Grove, California, United States
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Lemon Grove, California, United States
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National City, California, United States
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Oakland, California, United States
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Oceanside, California, United States
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Orange, California, United States
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Pico Rivera, California, United States
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Riverside, California, United States
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San Diego, California, United States
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San Marcos, California, United States
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Santa Rosa, California, United States
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Colorado Springs, Colorado, United States
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Bradenton, Florida, United States
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Fort Myers, Florida, United States
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Jacksonville, Florida, United States
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Lauderhill, Florida, United States
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Miami, Florida, United States
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North Miami, Florida, United States
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Orlando, Florida, United States
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Atlanta, Georgia, United States
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Chicago, Illinois, United States
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Hoffman Estates, Illinois, United States
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Lake Charles, Louisiana, United States
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Baltimore, Maryland, United States
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Boston, Massachusetts, United States
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O'Fallon, Missouri, United States
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St Louis, Missouri, United States
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Las Vegas, Nevada, United States
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Berlin, New Jersey, United States
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Cherry Hill, New Jersey, United States
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Marlton, New Jersey, United States
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Toms River, New Jersey, United States
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Brooklyn, New York, United States
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Cedarhurst, New York, United States
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New York, New York, United States
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Rochester, New York, United States

15 more sites on the registry record.ClinicalTrials.gov ↗

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

No drug or biological interventions are in our data for this study — it may test a procedure, device or behavioral intervention, or the intervention list isn't in our current snapshot. See the registry record ↗. Why? →

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 15 Dec 2015
Primary completion: 28 Jan 2019
Completion: 24 Jul 2019
Last update posted: 3 Nov 2025
Registered enrollment: 554
Registry id: NCT02600494

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 12 Jul 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.