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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lumateperone | Experimental | Lumateperone 42 mg (ITI-007 60 mg tosylate) administered once daily every evening for 6 weeks |
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| Placebo | Placebo Comparator | Placebo administered once daily every evening for 6 weeks |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lumateperone | Drug | Lumateperone 42 mg (ITI-007 60 mg tosylate) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score | The Montgomery-Åsberg Depression Rating Scale (MADRS) is a clinician-rated 10 item scale to assess depressive symptoms. Each item is rated on a 7-point scale from 0-6. The total score ranges from 0 to 60 with a higher score indicating increased severity of depressive symptoms. | Baseline to Day 43 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Clinical Global Impression Scale, Bipolar Version (CGI-BP-S) Total Score | The Clinical Global Impression Scale, Bipolar version (CGI-BP-S) total score is a clinician-rated scale that measures the patient's current illness state on a 3 to 21 point scale where a higher score is associated with greater illness severity.. Each domain (depression, mania, and overall illness) is rated from 1 (not ill at all) to 7 (among the most extremely ill) and the 3 scores are added to obtain the total score. |
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Major Inclusion Criteria:
Major Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Susan Kozauer, MD | Intra-Cellular Therapies, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Site | Birmingham | Alabama | 35294 | United States | ||
| Clinical Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41017591 | Derived | Durgam S, Lakkis H, Kozauer SG, Chen C, McIntyre RS. Efficacy of Lumateperone in depression associated with bipolar II disorder: a pooled analysis of late-phase clinical trials. CNS Spectr. 2025 Sep 29;30(1):e80. doi: 10.1017/S1092852925100564. | |
| 37103915 | Derived | McIntyre RS, Durgam S, Huo J, Kozauer SG, Stahl SM. The Efficacy of Lumateperone in Patients With Bipolar Depression With Mixed Features. J Clin Psychiatry. 2023 Apr 24;84(3):22m14739. doi: 10.4088/JCP.22m14739. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Lumateperone | Lumateperone 42 mg (ITI-007 60 mg tosylate) administered once daily every evening for 6 weeks Lumateperone: Lumateperone (ITI-007 60 mg tosylate) |
| FG001 | Placebo |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 5, 2018 | Apr 20, 2022 |
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| Placebo | Other | Placebo |
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| Baseline to Day 43 |
| Change From Baseline in Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF) Percent Score | The Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF) is a 14 item patient self-reported questionnaire that assesses how satisfied a patient is, using a 5-point scale from 1-very poor to 5-very good. | Baseline to Day 43 |
| Sherman Oaks |
| California |
| 91403 |
| United States |
| Clinical Site | Miami | Florida | 33133 | United States |
| Clinical Site | Orange City | Florida | 32763 | United States |
| Clinical Site | Atlanta | Georgia | 30322 | United States |
| Clinical Site | Decatur | Georgia | 30030 | United States |
| Clinical Site | Chicago | Illinois | 60612 | United States |
| Clinical Site | Joliet | Illinois | 60435 | United States |
| Clinical Site | Shreveport | Louisiana | 71101 | United States |
| Clinical Site | St Louis | Missouri | 63128 | United States |
| Clinical Site | Buffalo | New York | 14215 | United States |
| Clinical Site | Charlotte | North Carolina | 28211 | United States |
| Clinical Site | The Woodlands | Texas | 77381 | United States |
| Clinical Site | Bothell | Washington | 98011 | United States |
| Clinical Site | Burgas | Bulgaria |
| Clinical Site | Kardzhali | Bulgaria |
| Clinical Site | Lovech | Bulgaria |
| Clinical Site | Plovdiv | Bulgaria |
| Clinical Site | Rousse | Bulgaria |
| Clinical Site | Sofia | Bulgaria |
| Clinical Site | Targovishte | Bulgaria |
| Clinical Site | Tsarev Brod | Bulgaria |
| Clinical Site | Varna | Bulgaria |
| Clinical Site | Veliko Tarnovo | Bulgaria |
| Clinical Site | Barranquilla | Colombia |
| Clinical Site | Bello | Colombia |
| Clinical Site | Pereira | Colombia |
| Clinical Site | 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 | Yekaterinburg | Russia |
| Clinical Site | Belgrade | Serbia |
| Clinical Site | Kragujevac | Serbia |
| Clinical Site | Novi Sad | Serbia |
| Clinical Site | Ivano-Frankivsk | Ukraine |
| Clinical Site | Kharkiv | Ukraine |
| Clinical Site | Kherson | Ukraine |
| Clinical Site | Lviv | Ukraine |
| Clinical Site | Odesa | Ukraine |
| Clinical Site | Poltava | Ukraine |
| Clinical Site | Smila | Ukraine |
| Clinical Site | Uzhhorod | Ukraine |
| Clinical Site | Vinnytsia | Ukraine |
| 34551584 | Derived | Calabrese JR, Durgam S, Satlin A, Vanover KE, Davis RE, Chen R, Kozauer SG, Mates S, Sachs GS. Efficacy and Safety of Lumateperone for Major Depressive Episodes Associated With Bipolar I or Bipolar II Disorder: A Phase 3 Randomized Placebo-Controlled Trial. Am J Psychiatry. 2021 Dec;178(12):1098-1106. doi: 10.1176/appi.ajp.2021.20091339. Epub 2021 Sep 23. |
Placebo administered once daily every evening for 6 weeks
Placebo: Placebo
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Lumateperone | Lumateperone 42 mg (ITI-007 60 mg tosylate) administered once daily every evening for 6 weeks Lumateperone: Lumateperone 42 mg (ITI-007 60 mg tosylate) |
| BG001 | Placebo | Placebo administered once daily every evening for 6 weeks Placebo: Placebo |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Montgomery-Asberg Depression Rating Scale (MADRS) | The Montgomery-Åsberg Depression Rating Scale (MADRS) is a clinician-rated 10 item scale to assess depressive symptoms. Each item is rated on a 7-point scale from 0-6. The total score ranges from 0 to 60 with a higher score indicating increased severity of depressive symptoms. | Mean | Standard Deviation | units on a scale |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score | The Montgomery-Åsberg Depression Rating Scale (MADRS) is a clinician-rated 10 item scale to assess depressive symptoms. Each item is rated on a 7-point scale from 0-6. The total score ranges from 0 to 60 with a higher score indicating increased severity of depressive symptoms. | Intent-to-Treat (ITT) Set contains all randomized patients who received at least one dose of study medication and had a valid baseline (pre-dose) measurement and at least one valid post-baseline measurement of MADRS total score. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline to Day 43 |
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| Secondary | Change From Baseline in Clinical Global Impression Scale, Bipolar Version (CGI-BP-S) Total Score | The Clinical Global Impression Scale, Bipolar version (CGI-BP-S) total score is a clinician-rated scale that measures the patient's current illness state on a 3 to 21 point scale where a higher score is associated with greater illness severity.. Each domain (depression, mania, and overall illness) is rated from 1 (not ill at all) to 7 (among the most extremely ill) and the 3 scores are added to obtain the total score. | Intent-to-Treat (ITT) Set contains all randomized patients who received at least one dose of study medication and had a valid baseline (pre-dose) measurement and at least one valid post-baseline measurement of MADRS total score. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline to Day 43 |
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| Secondary | Change From Baseline in Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF) Percent Score | The Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF) is a 14 item patient self-reported questionnaire that assesses how satisfied a patient is, using a 5-point scale from 1-very poor to 5-very good. | Intent-to-Treat (ITT) Set contains all randomized patients who received at least one dose of study medication and had a valid baseline (pre-dose) measurement and at least one valid post-baseline measurement of MADRS total score. | Posted | Least Squares Mean | Standard Error | Percent Score | Baseline to Day 43 |
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From signing ICF until end of study procedures (~10 weeks), including 6 weeks of double-blind treatment.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Lumateperone | Lumateperone 42 mg (ITI-007 60 mg tosylate) administered once daily every evening for 6 weeks Lumateperone: Lumateperone 42 mg (ITI-007 60 mg tosylate) | 0 | 188 | 1 | 188 | 58 | 188 |
| EG001 | Placebo | Placebo administered once daily every evening for 6 weeks Placebo: Placebo | 0 | 189 | 0 | 189 | 31 | 189 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Mania | Psychiatric disorders | MedDRA 20.1 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
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| Somnolence | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
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| Nauseau | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| ITI Clinical Trials | Intra-Cellular Therapies, Inc. | 646-440-9333 | ITCIClinicalTrials@itci-inc.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 12, 2019 | Apr 20, 2022 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D001714 | Bipolar Disorder |
| ID | Term |
|---|---|
| D000068105 | Bipolar and Related Disorders |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| C000705749 | lumateperone |
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| Male |
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| Black or African American |
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| Asian |
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| Other |
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| Ukraine |
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| Bulgaria |
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| Serbia |
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| Russia |
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| Colombia |
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| Participants |
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