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The purpose of this study is to evaluate whether ITI-007 is effective in reducing symptoms associated with schizophrenia in patients who are having an acute worsening of their psychosis. Patients will be randomly assigned to receive one of two doses of ITI-007, placebo, or a positive control. The primary goal will be to assess the effects of ITI-007 on psychosis. The safety of ITI-007 will also be assessed.
The study will be conducted as a randomized, double-blind, placebo-controlled, multi-center study in patients diagnosed with schizophrenia and an acute exacerbation of psychosis. The efficacy and safety of two dose levels of ITI-007 administered daily for 28 days will be evaluated as compared to placebo; risperidone has been included as a positive control.
Upon completion of the inpatient 28-day Study Treatment Period, patients will be started on standard antipsychotic medication and will be stabilized over a 5-day period before discharge from the study clinic. Patients will be seen for a final outpatient safety evaluation at the End-of-Study visit approximately 2 weeks after discharge.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ITI-007 Low Dose | Experimental | Lumateperone 42 mg (ITI-007 60 mg tosylate) administered for 28 days |
|
| ITI-007 High Dose | Experimental | Lumateperone 84 mg (ITI-007 120 mg tosylate) administered for 28 days |
|
| Placebo | Placebo Comparator | Placebo: Capsules containing inactive placebo administered for 28 days |
|
| Risperidone | Active Comparator | Risperidone: Capsules containing 4 mg risperidone administered for 28 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ITI-007 | Drug | Capsules containing ITI-007 for 28 days |
| |
| 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. | Change from baseline to Day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline to Day 8 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kimberly E Vanover, PhD | Intra-Cellular Therapies | 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. | |
| 26444072 | Derived | Lieberman JA, Davis RE, Correll CU, Goff DC, Kane JM, Tamminga CA, Mates S, Vanover KE. ITI-007 for the Treatment of Schizophrenia: A 4-Week Randomized, Double-Blind, Controlled Trial. Biol Psychiatry. 2016 Jun 15;79(12):952-61. doi: 10.1016/j.biopsych.2015.08.026. Epub 2015 Aug 31. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Lumateperone 42 mg (ITI-007 60 mg Tosylate) | Lumateperone 42 mg (ITI-007 60 mg tosylate) administered for 28 days |
| FG001 | Lumateperone 84 mg (ITI-007 120 mg Tosylate) | Lumateperone 84 mg (ITI-007 120 mg tosylate) administered for 28 days |
| FG002 | Placebo | Placebo: Capsules containing inactive placebo administered for 28 days |
| FG003 | Risperidone 4 mg | Risperidone: Capsules containing 4 mg risperidone administered for 28 days |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
All Baseline data are presented for patients who received at least one dose of study drug, with the exception of the PANSS total score which is presented for patients who received at least 4 doses of study drug and who had a baseline measurement as well as at least 1 valid post-baseline efficacy measurement.
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| ID | Title | Description |
|---|---|---|
| BG000 | Lumateperone 42 mg (ITI-007 60 mg Tosylate) | Lumateperone 42 mg (ITI-007 60 mg tosylate) administered for 28 days Lumateperone 42 |
| BG001 | Lumateperone 84 mg (ITI-007 120 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. | The study was powered for prespecified comparison of both doses of ITI-007 with placebo using a Bonferroni correction for multiple comparisons. The study was not statistically powered to include multiple comparisons of risperidone to placebo and thus, the risperidone 4mg treatment group was included in the model fitting but was not included in the adjustment for multiplicity or primary outcomes determination. | Posted | Least Squares Mean | Standard Error | score on a scale | Change from baseline to Day 28 |
|
From signing ICF until end of study procedures (~ weeks) 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 42 mg (ITI-007 60 mg Tosylate) | Lumateperone 42 mg (ITI-007 60 mg tosylate) administered for 28 days Lumateperone 42 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Psychotic disorders | Psychiatric disorders | MedDRA (14.1) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Sedation | Nervous system disorders | MedDRA (14.1) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| ITI Clinical Trials | Intra-Cellular Therapies, Inc. | 646-440-9333 | ITCIClinialTrials@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 |
| D018967 | Risperidone |
| ID | Term |
|---|---|
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Placebo |
| Drug |
Capsules containing inactive placebo for 28 days |
|
| Risperidone | Drug | Capsules containing risperidone for 28 days |
|
| Change from Baseline to Day 8 |
| Change From Baseline to Day 15 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. | Change from Baseline to Day 15 |
| Change From Baseline to Day 22 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. | Change from Baseline to Day 22 |
| Garden Grove |
| California |
| United States |
| Clinical Site | Atlanta | Georgia | United States |
| Clinical Site | Rockville | Maryland | United States |
| Clinical Site | St Louis | Missouri | United States |
| Clinical Site | Willingboro | New Jersey | United States |
| Clinical Site | Philadelphia | Pennsylvania | United States |
| Clinical Site | Austin | Texas | United States |
| Physician Decision |
|
| Specific Request of Sponsor or Investigator |
|
| Adverse Event |
|
| Lack of Efficacy |
|
| Other |
|
Lumateperone 84 mg (ITI-007 120 mg tosylate) administered for 28 days
Lumateperone 84
| BG002 | Placebo | Placebo: Capsules containing inactive placebo administered for 28 days |
| BG003 | Risperidone 4 mg | Risperidone: Capsules containing 4 mg risperidone administered for 28 days |
| BG004 | 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. | PANSS total score Baseline presented for patients who received at least 4 doses of study drug and who had a baseline measurement as well as at least 1 valid post-baseline efficacy measurement (i.e., a measurement after at least 4 doses of study drug). | Mean | Standard Deviation | units on a scale |
|
| OG000 | Lumateperone 42 mg (ITI-007 60 mg Tosylate) | Lumateperone 42 mg (ITI-007 60 mg tosylate) administered for 28 days Lumateperone 42 |
| OG001 | Lumateperone 84 mg (ITI-007 120 mg Tosylate) | Lumateperone 84 mg (ITI-007 120 mg tosylate) administered for 28 days Lumateperone 84 |
| OG002 | Placebo | Placebo: Capsules containing inactive placebo administered for 28 days |
| OG003 | Risperidone 4 mg | Risperidone: Capsules containing 4 mg risperidone administered for 28 days |
|
|
|
| Secondary | Change From Baseline to Day 8 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. | ITT Population with LOCF | Posted | Least Squares Mean | Standard Error | units on a scale | Change from Baseline to Day 8 |
|
|
|
| Secondary | Change From Baseline to Day 15 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. | ITT Population with LOCF | Posted | Least Squares Mean | Standard Error | units on a scale | Change from Baseline to Day 15 |
|
|
|
| Secondary | Change From Baseline to Day 22 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 | Change from Baseline to Day 22 |
|
|
|
| 0 |
| 84 |
| 0 |
| 84 |
| 39 |
| 84 |
| EG001 | Lumateperone 84 mg (ITI-007 120 mg Tosylate) | Lumateperone 84 mg (ITI-007 120 mg tosylate) administered for 28 days Lumateperone 84 | 0 | 83 | 0 | 83 | 52 | 83 |
| EG002 | Placebo | Placebo: Capsules containing inactive placebo administered for 28 days | 0 | 85 | 1 | 85 | 28 | 85 |
| EG003 | Risperidone 4 mg | Risperidone: Capsules containing 4 mg risperidone administered for 28 days | 0 | 82 | 1 | 82 | 37 | 82 |
| Schizophrenia | Psychiatric disorders | MedDRA (14.1) | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (14.1) | Systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA (14.1) | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA (14.1) | Systematic Assessment |
|
| Akathisia | Nervous system disorders | MedDRA (14.1) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (14.1) | Systematic Assessment |
|
| Dry Mouth | Gastrointestinal disorders | MedDRA (14.1) | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA (14.1) | Systematic Assessment |
|
| Weight Increased | Investigations | MedDRA (14.1) | Systematic Assessment |
|
| Blood Creatine Phosphokinase Increased | Investigations | MedDRA (14.1) | Systematic Assessment |
|
| Alanine Aminotransferase Increased | Investigations | MedDRA (14.1) | Systematic Assessment |
|
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| Male |
|
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