Clinical trialNCT03249376CompletedPhase 3Interventional

Lumateperone Monotherapy for the Treatment of Bipolar Depression Conducted Globally

SponsorIntra-Cellular Therapies, Inc.Enrollment381Bipolar Depression

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

clinicaltrials.gov ↗

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.
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

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

Bulgaria

Clinical Site
Burgas, Bulgaria
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Kardzhali, Bulgaria
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Lovech, Bulgaria
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Plovdiv, Bulgaria
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Rousse, Bulgaria
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Sofia, Bulgaria
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Targovishte, Bulgaria
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Tsarev Brod, Bulgaria
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Varna, Bulgaria
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Veliko Tarnovo, Bulgaria

Colombia

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Barranquilla, Colombia
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Bello, Colombia
Clinical Site
Pereira, Colombia

Russia

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Moscow, Russia
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Nizhny Novgorod, Russia
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Omsk, Russia
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Saint Petersburg, Russia
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Samara, Russia
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Saratov, Russia
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Tomsk, Russia
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Yekaterinburg, Russia

Serbia

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Belgrade, Serbia
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Kragujevac, Serbia
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Novi Sad, Serbia

Ukraine

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Ivano-Frankivsk, Ukraine
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Kharkiv, Ukraine
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Kherson, Ukraine
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Lviv, Ukraine
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Odesa, Ukraine
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Poltava, Ukraine
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Smila, Ukraine
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Uzhhorod, Ukraine
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Vinnytsia, Ukraine

United States

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Birmingham, Alabama, United States
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Sherman Oaks, California, United States
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Miami, Florida, United States
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Orange City, Florida, United States
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Atlanta, Georgia, United States
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Decatur, Georgia, United States
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Chicago, Illinois, United States

7 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

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Lumateperone →

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

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

Start: 27 Nov 2017
Primary completion: 1 Mar 2019
Completion: 1 Mar 2019
Last update posted: 3 Jun 2022
Registered enrollment: 381
Registry id: NCT03249376

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; FindMyKOL does not interpret them.