Clinical Trial Evaluating ITI-007 as an Adjunctive Therapy to Lithium or Valproate for the Treatment of Bipolar Depression
NCT ID: NCT02600507
Last Updated: 2023-05-17
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
529 participants
INTERVENTIONAL
2016-03-07
2020-07-02
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Lumateperone 28 mg (ITI-007 40 mg tosylate)
Lumateperone 28 mg (ITI-007 40 mg tosylate) administered orally as capsules once daily for 6 weeks
Lumateperone (ITI-007)
Lumateperone 42 mg (ITI-007 60 mg tosylate)
Lumateperone 42 mg (ITI-007 60 mg tosylate) administered orally as capsules once daily for 6 weeks
Lumateperone (ITI-007)
Placebo
Placebo administered orally as visually-matched capsules once daily for 6 weeks
Placebo
Interventions
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Lumateperone (ITI-007)
Placebo
Eligibility Criteria
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Inclusion Criteria
* experiencing a current major depressive episode
* treatment with either lithium or valproate and inadequate therapeutic response of depressive symptoms
Exclusion Criteria
* any female subject who is pregnant or breastfeeding
* any subject judged to be medically inappropriate for study participation
18 Years
75 Years
ALL
No
Sponsors
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Intra-Cellular Therapies, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Susan Kozauer, MD
Role: STUDY_DIRECTOR
Intra-Cellular Therapies, Inc.
Locations
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Clinical Site
Rogers, Arkansas, United States
Clinical Site
Cerritos, California, United States
Clinical Site
Costa Mesa, California, United States
Clinical Site
Culver City, California, United States
Clinical Site
Garden Grove, California, United States
Clinical Site
Glendale, California, United States
Clinical Site
Lemon Grove, California, United States
Clinical Site
Oceanside, California, United States
Clinical Site
Pico Rivera, California, United States
Clinical Site
Riverside, California, United States
Clinical Site
San Diego, California, United States
Clinical Site
Santa Rosa, California, United States
Clinical Site
Sherman Oaks, California, United States
Clinical Site
Temecula, California, United States
Clinical Site
Jacksonville, Florida, United States
Clinical Site
Lauderhill, Florida, United States
Clinical Site
Miami, Florida, United States
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Orange City, Florida, United States
Clinical Site
Orlando, Florida, United States
Clinical Site
Atlanta, Georgia, United States
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Savannah, Georgia, United States
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Chicago, Illinois, United States
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Lake Charles, Louisiana, United States
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Baltimore, Maryland, 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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Toms River, New Jersey, United States
Clinical Site
Cedarhurst, New York, United States
Clinical Site
New York, New York, United States
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Rochester, New York, United States
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Staten Island, New York, United States
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Charlotte, North Carolina, United States
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Cincinnati, Ohio, United States
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Dayton, Ohio, United States
Clinical Site
Garfield Heights, Ohio, United States
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Allentown, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
Clinical Site
The Woodlands, Texas, United States
Clinical Site
Everett, Washington, United States
Clinical Site
Burgas, , Bulgaria
Clinical Site
Kardzhali, , Bulgaria
Clinical Site
Lovech, , Bulgaria
Clinical Site
Pleven, , Bulgaria
Clinical Site
Plovdiv, , Bulgaria
Clinical Site
Rousse, , Bulgaria
Clinical Site
Sofia, , Bulgaria
Clinical Site
Varna, , Bulgaria
Clinical Site
Veliko Tarnovo, , Bulgaria
Clinical Site
Vratsa, , Bulgaria
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Moscow, , Russia
Clinical Site
Nizhny Novgorod, , Russia
Clinical Site
Omsk, , Russia
Clinical Site
Saint Petersburg, , Russia
Clinical Site
Samara, , Russia
Clinical Site
Saratov, , Russia
Clinical Site
Tomsk, , Russia
Clinical Site
Belgrade, , Serbia
Clinical Site
Kovin, , Serbia
Clinical Site
Novi Sad, , Serbia
Clinical Site
Šumadija, , Serbia
Clinical Site
Ivano-Frankivsk, , Ukraine
Clinical Site
Kharkiv, , Ukraine
Clinical Site
Kropyvnytskyi, , Ukraine
Clinical Site
Odesa, , Ukraine
Clinical Site
Poltava, , Ukraine
Clinical Site
Smila, , Ukraine
Clinical Site
Vasylkiv, , Ukraine
Clinical Site
Vinnytsia, , Ukraine
Countries
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References
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Suppes T, Durgam S, Kozauer SG, Chen R, Lakkis HD, Davis RE, Satlin A, Vanover KE, Mates S, McIntyre RS, Tohen M. Adjunctive lumateperone (ITI-007) in the treatment of bipolar depression: Results from a randomized placebo-controlled clinical trial. Bipolar Disord. 2023 Sep;25(6):478-488. doi: 10.1111/bdi.13310. Epub 2023 Feb 26.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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ITI-007-402
Identifier Type: -
Identifier Source: org_study_id
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