Schizophrenia
Conditions
Brief summary
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.
Interventions
DRUGITI-007
DRUGPlacebo
Sponsors
Intra-Cellular Therapies, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* male or female subjects of any race, ages 18-60 inclusive, with a clinical diagnosis of schizophrenia * experiencing an acute exacerbation of psychosis
Exclusion criteria
* any subject unable to provide informed consent * any female subject who is pregnant or breast-feeding * any subject judged to be medically inappropriate for study participation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline to Day 28 in Positive and Negative Syndrome Scale (PANSS) Total Score | 28 days | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline to Day 28 in Clinical Global Impressions-Severity of Illness Scale | 28 days | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 150 |
| 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 | 150 |
| Placebo Placebo administered orally as formulated capsules once daily for 28 days
Placebo | 149 |
| Total | 449 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 6 | 2 | 0 |
| Overall Study | Death | 0 | 0 | 1 |
| Overall Study | Lack of Efficacy | 11 | 6 | 17 |
| Overall Study | Lost to Follow-up | 2 | 2 | 1 |
| Overall Study | Other | 3 | 2 | 1 |
| Overall Study | Physician Decision | 0 | 0 | 2 |
| Overall Study | Withdrawal by Subject | 8 | 10 | 16 |
Baseline characteristics
| Characteristic | Lumateperone 28 mg (ITI-007 40 mg Tosylate) | Lumateperone 42 mg (ITI-007 60 mg Tosylate) | Placebo | Total |
|---|---|---|---|---|
| Age, Continuous | 43.5 years STANDARD_DEVIATION 10.08 | 42.4 years STANDARD_DEVIATION 10.3 | 41.4 years STANDARD_DEVIATION 10.29 | 42.4 years STANDARD_DEVIATION 10.23 |
| Positive and Negative Syndrome Scale (PANSS) total score | 89.2 units on a scale STANDARD_DEVIATION 10.13 | 90.2 units on a scale STANDARD_DEVIATION 9.58 | 90.6 units on a scale STANDARD_DEVIATION 11.26 | 90.0 units on a scale STANDARD_DEVIATION 10.34 |
| Race/Ethnicity, Customized Asian | 6 Participants | 1 Participants | 1 Participants | 8 Participants |
| Race/Ethnicity, Customized Black or African American | 94 Participants | 108 Participants | 96 Participants | 298 Participants |
| Race/Ethnicity, Customized Other | 8 Participants | 8 Participants | 10 Participants | 26 Participants |
| Race/Ethnicity, Customized White | 42 Participants | 33 Participants | 42 Participants | 117 Participants |
| Sex: Female, Male Female | 37 Participants | 40 Participants | 26 Participants | 103 Participants |
| Sex: Female, Male Male | 113 Participants | 110 Participants | 123 Participants | 346 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 150 | 0 / 150 | 1 / 149 |
| other Total, other adverse events | 55 / 150 | 70 / 150 | 41 / 149 |
| serious Total, serious adverse events | 1 / 150 | 0 / 150 | 1 / 149 |
Outcome results
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.
Time frame: 28 days
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Lumateperone 28 mg (ITI-007 40 mg Tosylate) | Change From Baseline to Day 28 in Positive and Negative Syndrome Scale (PANSS) Total Score | -12.9 units on a scale | Standard Error 1.27 |
| Lumateperone 42 mg (ITI-007 60 mg Tosylate) | Change From Baseline to Day 28 in Positive and Negative Syndrome Scale (PANSS) Total Score | -14.5 units on a scale | Standard Error 1.25 |
| Placebo | Change From Baseline to Day 28 in Positive and Negative Syndrome Scale (PANSS) Total Score | -10.3 units on a scale | Standard Error 1.32 |
p-value: 0.18295% CI: [-6.17, 1.05]Mixed Effects Model for Repeated Measure
p-value: 0.04595% CI: [-7.75, -0.6]Mixed Effects Model for Repeated Measure
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.
Time frame: 28 days
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Lumateperone 28 mg (ITI-007 40 mg Tosylate) | Change From Baseline to Day 28 in Clinical Global Impressions-Severity of Illness Scale | -0.8 units on a scale | Standard Error 0.08 |
| Lumateperone 42 mg (ITI-007 60 mg Tosylate) | Change From Baseline to Day 28 in Clinical Global Impressions-Severity of Illness Scale | -0.8 units on a scale | Standard Error 0.07 |
| Placebo | Change From Baseline to Day 28 in Clinical Global Impressions-Severity of Illness Scale | -0.5 units on a scale | Standard Error 0.08 |
p-value: 0.04595% CI: [-0.54, -0.12]Mixed Effects Model for Repeated Measure