A Trial to Assess the Antipsychotic Efficacy of ITI-007
NCT ID: NCT02282761
Last Updated: 2025-10-02
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
450 participants
INTERVENTIONAL
2014-11-30
2015-09-30
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 formulated capsules once daily for 28 days
ITI-007
Lumateperone 42 mg (ITI-007 60 mg Tosylate)
Lumateperone 42 mg (ITI-007 60 mg Tosylate) administered orally as formulated capsules once daily for 28 days
ITI-007
Placebo
Placebo administered orally as formulated capsules once daily for 28 days
Placebo
Interventions
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ITI-007
Placebo
Eligibility Criteria
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Inclusion Criteria
* experiencing an acute exacerbation of psychosis
Exclusion Criteria
* any female subject who is pregnant or breast-feeding
* any subject judged to be medically inappropriate for study participation
18 Years
60 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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Kimberly Vanover, Ph.D.
Role: STUDY_DIRECTOR
Intra-Cellular Therapies, Inc.
Locations
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Clinical Site
Little Rock, Arkansas, United States
Clinical Site
Springdale, Arkansas, United States
Clinical Site
Escondido, California, United States
Clinical Site
Garden Grove, California, United States
Clinical Site
Long Beach, California, United States
Clinical Site
San Diego, California, United States
Clinical Site
Fort Lauderdale, Florida, United States
Clinical Site
Rockville, Maryland, United States
Clinical Site
St Louis, Missouri, United States
Clinical Site
Marlton, New Jersey, United States
Clinical Site
Austin, Texas, United States
Countries
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References
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Citrome L, Durgam S, Edwards JB, Davis RE. Lumateperone for the Treatment of Schizophrenia: Number Needed to Treat, Number Needed to Harm, and Likelihood to Be Helped or Harmed. J Clin Psychiatry. 2023 Mar 6;84(2):22r14631. doi: 10.4088/JCP.22r14631.
Correll CU, Davis RE, Weingart M, Saillard J, O'Gorman C, Kane JM, Lieberman JA, Tamminga CA, Mates S, Vanover KE. Efficacy and Safety of Lumateperone for Treatment of Schizophrenia: A Randomized Clinical Trial. JAMA Psychiatry. 2020 Apr 1;77(4):349-358. doi: 10.1001/jamapsychiatry.2019.4379.
Other Identifiers
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ITI-007-301
Identifier Type: -
Identifier Source: org_study_id
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