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The study will evaluate the antipsychotic efficacy of ITI-007 in a randomized, double-blind, parallel-group, placebo- and active-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 14 mg (ITI-007 20 mg Tosylate) | Experimental | Lumateperone 14 mg (ITI-007 20 mg Tosylate) administered orally as formulated 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 formulated capsules once daily for 6 weeks |
|
| Placebo | Placebo Comparator | Placebo administered orally as visually-matched capsules once daily for 6 weeks |
|
| Risperidone | Active Comparator | Risperidone administered orally as visually-matched over-encapsulated tablet once daily for 6 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ITI-007 | Drug |
| ||
| Risperidone |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline to Week 6 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. | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline to Week 6 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Lumateperone 14 mg (ITI-007 20 mg Tosylate) | Lumateperone 14 mg (ITI-007 20 mg Tosylate) administered orally as formulated capsules once daily for 6 weeks ITI-007 |
| FG001 | Lumateperone 42 mg (ITI-007 60 mg Tosylate) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Drug |
|
| Placebo | Drug |
|
| 6 weeks |
| Springdale |
| Arkansas |
| United States |
| Clinical Site | Culver City | California | United States |
| Clinical Site | Lemon Grove | California | United States |
| Clinical Site | Long Beach | California | United States |
| Clinical Site | San Diego | California | United States |
| Clinical Site | North Miami | Florida | United States |
| Clinical Site | Berlin | New Jersey | United States |
| Clinical Site | Marlton | New Jersey | United States |
| Clinical Site | Austin | Texas | United States |
| Clinical Site | Dallas | Texas | United States |
Lumateperone 42 mg (ITI-007 60 mg Tosylate) administered orally as formulated capsules once daily for 6 weeks
ITI-007
| FG002 | Placebo | Placebo administered orally as visually-matched capsules once daily for 6 weeks Placebo |
| FG003 | Risperidone | Risperidone administered orally as visually-matched over-encapsulated tablet once daily for 6 weeks Risperidone |
| COMPLETED |
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| NOT COMPLETED |
|
|
4 subjects received an incorrect treatment compared to that which they were randomized. The numbers presented in Baseline Characteristics are as treated in each group except as noted.
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| ID | Title | Description |
|---|---|---|
| BG000 | Lumateperone 14 mg (ITI-007 20 mg Tosylate) | Lumateperone 14 mg (ITI-007 20 mg Tosylate) administered orally as formulated capsules once daily for 6 weeks ITI-007 |
| BG001 | Lumateperone 42 mg (ITI-007 60 mg Tosylate) | Lumateperone 42 mg (ITI-007 60 mg Tosylate) administered orally as formulated capsules once daily for 6 weeks ITI-007 |
| BG002 | Placebo | Placebo administered orally as visually-matched capsules once daily for 6 weeks Placebo |
| BG003 | Risperidone | Risperidone administered orally as visually-matched over-encapsulated tablet once daily for 6 weeks Risperidone |
| BG004 | 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 |
| ||||||||||||||||
| 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 |
|
| 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 Week 6 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. | Analysis was conducted using the ITT analysis set, which includes all subjects who were randomized, received at least 1 dose of study medication, and had a valid baseline and at least 1 valid post-baseline PANSS measurement. | Posted | Least Squares Mean | Standard Error | units on a scale | 6 weeks |
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| Secondary | Change From Baseline to Week 6 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." | Not Posted | 6 weeks | Participants |
From signing ICF until end of study procedures (~10 weeks), including 6 weeks of double blind treatment.
4 subjects received an incorrect treatment compared to that which they were randomized. The numbers presented are as treated in each group.
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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 14 mg (ITI-007 20 mg Tosylate) | Lumateperone 14 mg (ITI-007 20 mg Tosylate) administered orally as formulated capsules once daily for 6 weeks ITI-007 | 0 | 172 | 0 | 172 | 57 | 172 |
| 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 6 weeks ITI-007 | 0 | 172 | 1 | 172 | 76 | 172 |
| EG002 | Placebo | Placebo administered orally as visually-matched capsules once daily for 6 weeks Placebo | 0 | 178 | 0 | 178 | 68 | 178 |
| EG003 | Risperidone | Risperidone administered orally as visually-matched over-encapsulated tablet once daily for 6 weeks Risperidone | 1 | 173 | 0 | 173 | 79 | 173 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Agitation | Psychiatric disorders | MedDRA version 17.1 | Systematic Assessment | Agitation (secondary to psychosis) |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | MedDRA version 17.1 | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA version 17.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA version 17.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA version 17.1 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA version 17.1 | Systematic Assessment |
| |
| Dry Mouth | Gastrointestinal disorders | MedDRA version 17.1 | Systematic Assessment |
| |
| Sedation | Nervous system disorders | MedDRA version 17.1 | Systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA version 17.1 | Systematic Assessment |
| |
| Weight Increased | Investigations | MedDRA version 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 |
| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| C000705749 | lumateperone |
| D018967 | Risperidone |
| ID | Term |
|---|---|
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Male |
|
| Back or African American |
|
| Asian |
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| Other |
|
| Least Squares Mean Difference |
| 0.5 |
| 2-Sided |
| 95 |
| -2.92 |
| 3.84 |
| Superiority |