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The study will be conducted as a randomized, double-blind, parallel-group, placebo-controlled, multi-center study in patients diagnosed with schizophrenia having an acute exacerbation of psychosis.
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| 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 formulated capsules once daily for 28 days |
|
| Lumateperone 42 mg (ITI-007 60 mg Tosylate) | Experimental | Lumateperone 42 mg (ITI-007 60 mg Tosylate) administered orally as formulated capsules once daily for 28 days |
|
| Placebo | Placebo Comparator | Placebo administered orally as formulated capsules once daily for 28 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ITI-007 | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline to Day 28 in Positive and Negative Syndrome Scale (PANSS) Total Score | The PANSS is a 30-item scale used to measure symptoms of schizophrenia. The scale has 7 positive symptom items, 7 negative symptom items, and 16 general psychopathology symptom items. Each item is scored on a 7-point scale by the clinical rater based on a clinical interview with the patient, with a score of 1 indicating the absence of symptoms and a score of 7 indicating extremely severe symptoms. Thus, the PANSS Total score minimum is 30 and the maximum is 210, with higher numbers indicating more severe symptoms. | 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline to Day 28 in Clinical Global Impressions-Severity of Illness Scale | The Clinical Global Impressions (CGI) Scale is a standardized assessment tool that the clinician can use to rate the severity of illness, change over time, and efficacy of medication, taking into account the subject's clinical condition and the severity of side effects. The CGI Scale consists of 3 global subscales, only one of which was used in the present study. The first subscale, Severity of Illness (CGI-S), assesses the clinician's impression of the subject's current illness state; it is often used both before and after treatment. Scores on the Severity of Illness subscale range from 1 = "not ill" at all to 7 = "among the most extremely ill." |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kimberly Vanover, Ph.D. | Intra-Cellular Therapies, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Site | Little Rock | Arkansas | United States | |||
| Clinical Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36883881 | Derived | 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. | |
| 31913424 | Derived | 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. |
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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 formulated capsules once daily for 28 days ITI-007 |
| FG001 | 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 |
| FG002 | Placebo | Placebo administered orally as formulated capsules once daily for 28 days Placebo |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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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 formulated capsules once daily for 28 days ITI-007 |
| BG001 | Lumateperone 42 mg (ITI-007 60 mg Tosylate) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 28 in Positive and Negative Syndrome Scale (PANSS) Total Score | The PANSS is a 30-item scale used to measure symptoms of schizophrenia. The scale has 7 positive symptom items, 7 negative symptom items, and 16 general psychopathology symptom items. Each item is scored on a 7-point scale by the clinical rater based on a clinical interview with the patient, with a score of 1 indicating the absence of symptoms and a score of 7 indicating extremely severe symptoms. Thus, the PANSS Total score minimum is 30 and the maximum is 210, with higher numbers indicating more severe symptoms. | Posted | Least Squares Mean | Standard Error | units on a scale | 28 days |
|
From signing ICF until end of study procedures (~49 days), including 28 days 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 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 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Convulsion | Nervous system disorders | MedDRA (17.1) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | MedDRA (17.1) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| ITI Clinical Trials | Intra-Cellular Therapies, Inc. | 646-440-9333 | ITCIClinicalTrials@itci-inc.com |
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| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| C000705749 | lumateperone |
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| Drug |
|
| 28 days |
| 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 |
| Lack of Efficacy |
|
| Lost to Follow-up |
|
| Physician Decision |
|
| Withdrawal by Subject |
|
| Other |
|
Lumateperone 42 mg (ITI-007 60 mg Tosylate) administered orally as formulated capsules once daily for 28 days
ITI-007
| BG002 | Placebo | Placebo administered orally as formulated capsules once daily for 28 days Placebo |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Positive and Negative Syndrome Scale (PANSS) total score | The PANSS is a 30-item scale used to measure symptoms of schizophrenia. The scale has 7 positive symptom items, 7 negative symptom items, and 16 general psychopathology symptom items. Each item is scored on a 7-point scale by the clinical rater based on a clinical interview with the patient, with a score of 1 indicating the absence of symptoms and a score of 7 indicating extremely severe symptoms. Thus, the PANSS Total score minimum is 30 and the maximum is 210, with higher numbers indicating more severe symptoms. | Mean | Standard Deviation | units on a scale |
|
| OG001 |
| 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 |
| OG002 | Placebo | Placebo administered orally as formulated capsules once daily for 28 days Placebo |
|
|
|
| Secondary | Change From Baseline to Day 28 in Clinical Global Impressions-Severity of Illness Scale | The Clinical Global Impressions (CGI) Scale is a standardized assessment tool that the clinician can use to rate the severity of illness, change over time, and efficacy of medication, taking into account the subject's clinical condition and the severity of side effects. The CGI Scale consists of 3 global subscales, only one of which was used in the present study. The first subscale, Severity of Illness (CGI-S), assesses the clinician's impression of the subject's current illness state; it is often used both before and after treatment. Scores on the Severity of Illness subscale range from 1 = "not ill" at all to 7 = "among the most extremely ill." | Posted | Least Squares Mean | Standard Error | units on a scale | 28 days |
|
|
|
|
| 0 |
| 150 |
| 1 |
| 150 |
| 55 |
| 150 |
| EG001 | 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 | 0 | 150 | 0 | 150 | 70 | 150 |
| EG002 | Placebo | Placebo administered orally as formulated capsules once daily for 28 days Placebo | 1 | 149 | 1 | 149 | 41 | 149 |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | Systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA (17.1) | Systematic Assessment |
|
| Sedation | Nervous system disorders | MedDRA (17.1) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
|
| Dry Mouth | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA (17.1) | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
|
| Fatigue | Nervous system disorders | MedDRA (17.1) | Systematic Assessment |
|
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