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The study will evaluate the efficacy and safety of ITI-007 (Lumateperone) in patients diagnosed with Bipolar I or Bipolar II disorder having a major depressive episode. The study will be conducted in two parts, Part A and Part B. Part A is a randomized, double-blind, placebo-controlled study. In Part B, patients who safely complete participation in part A may be enrolled in an open-label extension.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 40 mg ITI-007 (Lumateperone) | Experimental | 40 mg ITI-007 (Lumateperone) administered orally as capsules once daily for 6 weeks |
|
| 60 mg ITI-007 (Lumateperone) | Experimental | 60 mg ITI-007 (Lumateperone) 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 |
|---|---|---|---|---|
| ITI-007 (Lumateperone) | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline to Day 43 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. | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Time to First Sustained Response in Reduction of MADRS Total Score | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline to Day 175 in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score | The MADRS total score from baseline to Day 175 for patients that rolled over into the extension portion of the study (Part B) | Day 175 |
| Adverse Events |
Major Inclusion Criteria:
Major Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Susan Kozauer, MD | Intra-Cellular Therapies, Inc. (ITI) | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Site | Little Rock | 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. |
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Part A includes all patients who signed the informed consent and were randomized in to the 6 week double-blind treatment period. 554 patients were randomized; 549 patients received study drug and are included in the safety population.
Part B includes all patients who signed the informed consent and received open-label study drug for up to 6 months.
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| 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 ITI-007 (Lumateperone) |
| FG001 | Lumateperone 42 mg (ITI-007 60 mg Tosylate) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Part A (6 Week Double-Blind Treatment) |
|
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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 | Mar 9, 2018 | Mar 4, 2025 |
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| Drug |
|
Incidence of Treatment-Emergent Adverse Events from baseline to Day 175 for patients that rolled over into the extension portion of the study (Part B)
| Day 175 |
| Rogers |
| Arkansas |
| United States |
| Clinical Site | Cerritos | California | United States |
| Clinical Site | Culver City | California | United States |
| Clinical Site | Garden Grove | California | United States |
| Clinical Site | Lemon Grove | California | United States |
| Clinical Site | National City | California | United States |
| Clinical Site | Oakland | California | United States |
| Clinical Site | Oceanside | California | United States |
| Clinical Site | Orange | 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 | San Marcos | California | United States |
| Clinical Site | Santa Rosa | California | United States |
| Clinical Site | Colorado Springs | Colorado | United States |
| Clinical Site | Bradenton | Florida | United States |
| Clinical Site | Fort Myers | Florida | United States |
| Clinical Site | Jacksonville | Florida | United States |
| Clinical Site | Lauderhill | Florida | United States |
| Clinical Site | Miami | Florida | United States |
| Clinical Site | North Miami | Florida | United States |
| Clinical Site | Orlando | Florida | United States |
| Clinical Site | Atlanta | Georgia | United States |
| Clinical Site | Chicago | Illinois | United States |
| Clinical Site | Hoffman Estates | Illinois | United States |
| Clinical Site | Lake Charles | Louisiana | United States |
| Clinical Site | Baltimore | Maryland | United States |
| Clinical Site | Boston | Massachusetts | 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 | Marlton | New Jersey | United States |
| Clinical Site | Toms River | New Jersey | United States |
| Clinical Site | Brooklyn | New York | 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 | Cincinnati | Ohio | United States |
| Clinical Site | Cleveland | Ohio | United States |
| Clinical Site | Dayton | Ohio | United States |
| Clinical Site | Garfield Heights | Ohio | United States |
| Clinical Site | Oklahoma City | Oklahoma | United States |
| Clinical Site | Allentown | Pennsylvania | United States |
| Clinical Site | Norristown | Pennsylvania | United States |
| Clinical Site | Philadelphia | Pennsylvania | United States |
| Clinical Site | Memphis | Tennessee | United States |
| Clinical Site | Austin | Texas | United States |
| Clinical Site | Dallas | Texas | United States |
| Clinical Site | Houston | Texas | United States |
| Clinical Site | Petersburg | Virginia | United States |
| Clinical Site | Everett | Washington | United States |
Lumateperone 42 mg (ITI-007 60 mg tosylate) administered orally as capsules once daily for 6 weeks
Lumateperone (ITI-007)
| FG002 | Placebo | Placebo administered orally as visually-matched capsules once daily for 6 weeks Placebo |
| Number of Patients Randomized and Took at Least 1 Dose of Study Drug |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Part B (6 Month Open-Label Treatment) |
|
|
All patients in Part A Safety Analysis set which contains all patients who received at least one dose of study medication.
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| 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 ITI-007 (Lumateperone) |
| 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 (ITI-007) |
| 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 | Number | participants |
| ||||||||||||||||
| Montgomery Asberg Depression Rating Scale (MADRS) | 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 to Day 43 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 who 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 | 6 weeks |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to First Sustained Response in Reduction of MADRS Total Score | Posted | Median | 95% Confidence Interval | days | 6 weeks |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Change From Baseline to Day 175 in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score | The MADRS total score from baseline to Day 175 for patients that rolled over into the extension portion of the study (Part B) | Safety Analysis Set - all patients who received at least 1 dose of study medication in Part B | Posted | Mean | Standard Deviation | units on a scale | Day 175 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Adverse Events | Incidence of Treatment-Emergent Adverse Events from baseline to Day 175 for patients that rolled over into the extension portion of the study (Part B) | Posted | Count of Participants | Participants | Day 175 |
|
|
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 | Part A 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 ITI-007 (Lumateperone) | 0 | 180 | 5 | 180 | 72 | 180 |
| EG001 | Part A 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) | 0 | 184 | 0 | 184 | 67 | 184 |
| EG002 | Part A Placebo | Placebo administered orally as visually-matched capsules once daily for 6 weeks Placebo | 1 | 185 | 1 | 185 | 31 | 185 |
| EG003 | Part B Lumateperone 42 mg (ITI-007 60 mg Tosylate) | Lumateperone 42 mg (ITI-007 60 mg tosylate) administered orally as capsules once daily for up to 6 months Lumateperone (ITI-007) | 0 | 127 | 4 | 127 | 55 | 127 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Depression | Psychiatric disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Mania | Psychiatric disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Panic Attack | Psychiatric disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Suicidal Ideation | Psychiatric disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Agression | Psychiatric disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Anemia postoperative | Injury, poisoning and procedural complications | MedDRA (18.1) | Systematic Assessment |
| |
| Procedural hemorrhage | Injury, poisoning and procedural complications | MedDRA (18.1) | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Mental status changes | Psychiatric disorders | MedDRA (18.1) | Systematic Assessment |
| |
| colitis ulcerative | Gastrointestinal disorders | MedDRA (18.1) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Somnolence | Nervous system disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Dry Mouth | Gastrointestinal disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Irritability | Psychiatric disorders | MedDRA (18.1) | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Vice President, Clinical Development | Intra-Cellular Therapies, Inc. | 646-440-9333 | ITCIClinicalTrials@itci-inc.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 12, 2019 | Mar 4, 2025 | SAP_001.pdf |
| 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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| Protocol Violation |
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| Physician Decision |
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| Withdrawal by Subject |
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| Lost to Follow-up |
|
| Male |
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| Black or African American |
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| Asian |
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| American Indian or Alaska Native |
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| Native Hawaiian or Other Pacific Islander |
|
| Multiple |
|
| Not Reported |
|
| 0.895 |
p-value is Hochberg adjusted |
| Least Squares Mean Difference |
| -1.0 |
| 2-Sided |
| 95 |
| -3.73 |
| 1.79 |
| Superiority |
|
|
|
| Title | Denominators | Categories |
|---|
| Headache |
| |||||
| Dry Mouth |
| |||||
| Dizziness |
| |||||
| Nausea |
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| Somnolence |
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| Anxiety |
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| Irritability |
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