Clinical Trial Evaluating Lumateperone Monotherapy in the Treatment of Bipolar Depression or Major Depressive Disorder
NCT ID: NCT04285515
Last Updated: 2025-03-19
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
488 participants
INTERVENTIONAL
2020-02-27
2022-11-30
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 42mg
Lumateperone 42mg administered once daily in the evening
Lumateperone
Lumateperone 42mg oral capsule
Placebo
Matching placebo administered once daily in the evening
Placebos
Placebo oral capsule
Interventions
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Lumateperone
Lumateperone 42mg oral capsule
Placebos
Placebo oral capsule
Eligibility Criteria
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Inclusion Criteria
* Meets the Diagnostic and Statistical Manual of Mental Disorder, 5th Edition (DSM 5) criteria for Bipolar I or Bipolar II Disorder or MDD
* The start of the current major depressive episode is at least 2 weeks but no more than 6 months prior to the Screening (Visit 1)
* Has at least moderate severity of illness, as measured by a rater-administered MADRS total score ≥ 24 and corresponding to a CGI S score of ≥ 4 at Screening (Visit 1) and Baseline (Visit 2)
* The patient meets the DSM-5 criteria for mixed-features specific to the Bipolar I or II diagnosis or MDD diagnosis
* Current major depressive episode is causing clinically significant distress or impairment in social, occupational, or other important areas of functioning
* Able to provide written informed consent
Exclusion Criteria
* Any subject judged to be medically inappropriate for study participation
* The patient has a significant risk for suicidal behavior
* The patient presents with a lifetime history of epilepsy, seizure or convulsion, or electroencephalogram with clinically significant abnormalities, delirium, dementia, amnestic, or other cognitive disorder or significant brain trauma
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
Garden Grove, California, United States
Clinical Site
Oceanside, California, United States
Clinical Site
Sherman Oaks, California, United States
Clinical Site
Lauderhill, Florida, United States
Clinical Site
Miami, Florida, United States
Clinical Site
Orange City, Florida, United States
Clinical Site
Atlanta, Georgia, United States
Clinical Site
Decatur, Georgia, United States
Clinical Site
O'Fallon, Missouri, United States
Clinical Site
Cedarhurst, New York, United States
Clinical Site
New York, New York, United States
Clinical Site
Charlotte, North Carolina, United States
Clinical Site
Bellevue, Washington, United States
Clinical Site
Burgas, , Bulgaria
Clinical Site
Kardzhali, , Bulgaria
Clinical Site
Plovdiv, , Bulgaria
Clinical Site
Rousse, , Bulgaria
Clinical Site
Sofia, , Bulgaria
Clinical Site
Sofia, , Bulgaria
Clinical Site
Sofia, , Bulgaria
Clinical Site
Sofia, , Bulgaria
Clinical Site
Varna, , Bulgaria
Clinical Site
Veliko Tarnovo, , Bulgaria
Clinical Site
Vratsa, , Bulgaria
Clinical Site
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
Clinical Site
Tomsk, , Russia
Clinical Site
Yekaterinburg, , Russia
Clinical Site
Belgrade, , Serbia
Clinical Site
Kovin, , Serbia
Clinical Site
Kragujevac, , Serbia
Clinical Site
Kyiv, , Ukraine
Clinical Site
Lviv, , Ukraine
Clinical site
Odesa, , Ukraine
Clinical Site
Odesa, , Ukraine
Clinical Site
Poltava, , Ukraine
Clinical Site
Smila, , Ukraine
Clinical Site
Vinnytsia, , Ukraine
Countries
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References
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Durgam S, Kozauer SG, Earley WR, Chen C, Huo J, Lakkis H, Stahl S, McIntyre RS. Lumateperone for the Treatment of Major Depressive Disorder With Mixed Features or Bipolar Depression With Mixed Features: A Randomized Placebo-Controlled Trial. J Clin Psychopharmacol. 2025 Mar-Apr 01;45(2):67-75. doi: 10.1097/JCP.0000000000001964. Epub 2025 Feb 14.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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ITI-007-403
Identifier Type: -
Identifier Source: org_study_id
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