Clinical trialNCT04285515CompletedPhase 3Interventional

Clinical Trial Evaluating Lumateperone Monotherapy in the Treatment of Bipolar Depression or Major Depressive Disorder

SponsorIntra-Cellular Therapies, Inc.Enrollment488Bipolar DepressionMajor Depressive Disorder

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.
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

42 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
Clinical Site
Kardzhali, Bulgaria
Clinical Site
Plovdiv, Bulgaria
Clinical Site
Rousse, Bulgaria
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Sofia, Bulgaria
Clinical Site
Sofia, Bulgaria
Clinical Site
Sofia, Bulgaria
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Sofia, Bulgaria
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Varna, Bulgaria
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Veliko Tarnovo, Bulgaria
Clinical Site
Vratsa, Bulgaria

Russia

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Moscow, Russia
Clinical Site
Saint Petersburg, Russia
Clinical Site
Saint Petersburg, Russia
Clinical Site
Saint Petersburg, Russia
Clinical Site
Saint Petersburg, Russia
Clinical Site
Saint Petersburg, Russia
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Tomsk, Russia
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Yekaterinburg, Russia

Serbia

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Belgrade, Serbia
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Kovin, Serbia
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Kragujevac, Serbia

Ukraine

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Kyiv, Ukraine
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Lviv, Ukraine
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Odesa, Ukraine
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Odesa, Ukraine
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Poltava, Ukraine
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Smila, Ukraine
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Vinnytsia, Ukraine

United States

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Garden Grove, California, United States
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Oceanside, California, United States
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Sherman Oaks, California, United States
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Lauderhill, Florida, 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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O'Fallon, Missouri, United States
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Cedarhurst, New York, United States
Clinical Site
New York, New York, United States

2 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: 27 Feb 2020
Primary completion: 30 Nov 2022
Completion: 30 Nov 2022
Last update posted: 19 Mar 2025
Registered enrollment: 488
Registry id: NCT04285515

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.