Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The study will evaluate the efficacy and safety of ITI-007 adjunctive to lithium or valproate 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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lumateperone 28 mg (ITI-007 40 mg tosylate) | Experimental | Lumateperone 28 mg (ITI-007 40 mg tosylate) administered orally as capsules once daily for 6 weeks |
|
| Lumateperone 42 mg (ITI-007 60 mg tosylate) | Experimental | Lumateperone 42 mg (ITI-007 60 mg tosylate) administered orally as capsules once daily for 6 weeks |
|
| Placebo | Placebo Comparator | Placebo administered orally as visually-matched capsules once daily for 6 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lumateperone (ITI-007) | Drug |
| ||
| 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-Severity (CGI-BP-S) Depression Score | The Clinical Global Impression Scale-Bipolar Version-Severity (CGI-BP-S) Depression Score is a clinician-rated scale that measures the patient's current state of depression from 1 (not ill at all) to 7 (among the most extremely ill). | Baseline to Day 43 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Susan Kozauer, MD | Intra-Cellular Therapies, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Site | Rogers | Arkansas | 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. | |
| 36779257 | Derived | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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 28 mg |
| FG001 | Lumateperone 42 mg (ITI-007 60 mg Tosylate) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 4, 2019 | Apr 24, 2023 |
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo |
| Drug |
|
| 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 |
| Clinical Site | Orange City | Florida | United States |
| Clinical Site | Orlando | Florida | United States |
| Clinical Site | Atlanta | Georgia | United States |
| Clinical Site | Savannah | Georgia | United States |
| Clinical Site | Chicago | Illinois | United States |
| Clinical Site | Lake Charles | Louisiana | United States |
| Clinical Site | Baltimore | Maryland | United States |
| Clinical Site | O'Fallon | Missouri | United States |
| Clinical Site | St Louis | Missouri | United States |
| Clinical Site | Las Vegas | Nevada | United States |
| Clinical Site | Berlin | New Jersey | United States |
| Clinical Site | Cherry Hill | New Jersey | United States |
| Clinical Site | Toms River | New Jersey | United States |
| Clinical Site | Cedarhurst | New York | United States |
| Clinical Site | New York | New York | United States |
| Clinical Site | Rochester | New York | United States |
| Clinical Site | Staten Island | New York | United States |
| Clinical Site | Charlotte | North Carolina | United States |
| Clinical Site | Cincinnati | Ohio | United States |
| Clinical Site | Dayton | Ohio | United States |
| Clinical Site | Garfield Heights | Ohio | United States |
| Clinical Site | Allentown | Pennsylvania | United States |
| Clinical Site | 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 |
| 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 | 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 |
Lumateperone 42 mg (ITI-007 60 mg tosylate) administered orally as capsules once daily for 6 weeks
Lumateperone 42
| FG002 | Placebo | Placebo administered orally as visually-matched capsules once daily for 6 weeks Placebo |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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 28 mg |
| BG001 | 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 42 mg |
| BG002 | Placebo | Placebo administered orally as visually-matched capsules once daily for 6 weeks Placebo |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||
| Montgomery-Asberg Depression Rating Scale (MADRS) | The Montgomery-Asberg 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 |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Clinical Global Impression Scale-Bipolar Version-Severity (CGI-BP-S) Depression Score | The Clinical Global Impression Scale-Bipolar Version-Severity (CGI-BP-S) Depression Score is a clinician-rated scale that measures the patient's current state of depression from 1 (not ill at all) to 7 (among the most extremely ill). | 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 |
|
From signing ICF until end of study procedures (~10 weeks), including 6 weeks of double-blind treatment.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 28 mg | 0 | 176 | 0 | 176 | 50 | 176 |
| EG001 | 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 42 mg | 0 | 177 | 1 | 177 | 47 | 177 |
| EG002 | Placebo | Placebo administered orally as visually-matched capsules once daily for 6 weeks Placebo | 0 | 175 | 0 | 175 | 28 | 175 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Toxicity to various agents | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
Not provided
Not provided
| 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 | Aug 11, 2020 | Apr 24, 2023 | SAP_001.pdf |
| ID | Term |
|---|---|
| D001714 | Bipolar Disorder |
| ID | Term |
|---|---|
| D000068105 | Bipolar and Related Disorders |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| C000705749 | lumateperone |
Not provided
Not provided
Not provided
| Male |
|
| Black or African American |
|
| Asian |
|
| Other |
|
| Ukraine |
|
| Bulgaria |
|
| Serbia |
|
| Russia |
|
| 0.099 |
| Least Squares Mean Difference |
| -1.7 |
| Standard Error of the Mean |
| 1.01 |
| 2-Sided |
| 95 |
| -3.65 |
| 0.32 |
| Superiority |
| Units | Counts |
|---|---|
| Participants |
|
|
|