Trial Outcomes & Findings for Study of a Novel Antipsychotic ITI-007 in Schizophrenia (NCT NCT01499563)
NCT ID: NCT01499563
Last Updated: 2025-10-03
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
335 participants
Primary outcome timeframe
Change from baseline to Day 28
Results posted on
2025-10-03
Participant Flow
Participant milestones
| Measure |
Lumateperone 42 mg (ITI-007 60 mg Tosylate)
Lumateperone 42 mg (ITI-007 60 mg tosylate) administered for 28 days
|
Lumateperone 84 mg (ITI-007 120 mg Tosylate)
Lumateperone 84 mg (ITI-007 120 mg tosylate) administered for 28 days
|
Placebo
Placebo: Capsules containing inactive placebo administered for 28 days
|
Risperidone 4 mg
Risperidone: Capsules containing 4 mg risperidone administered for 28 days
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
84
|
83
|
85
|
82
|
|
Overall Study
COMPLETED
|
60
|
64
|
61
|
63
|
|
Overall Study
NOT COMPLETED
|
24
|
19
|
24
|
19
|
Reasons for withdrawal
| Measure |
Lumateperone 42 mg (ITI-007 60 mg Tosylate)
Lumateperone 42 mg (ITI-007 60 mg tosylate) administered for 28 days
|
Lumateperone 84 mg (ITI-007 120 mg Tosylate)
Lumateperone 84 mg (ITI-007 120 mg tosylate) administered for 28 days
|
Placebo
Placebo: Capsules containing inactive placebo administered for 28 days
|
Risperidone 4 mg
Risperidone: Capsules containing 4 mg risperidone administered for 28 days
|
|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
10
|
11
|
7
|
8
|
|
Overall Study
Physician Decision
|
2
|
1
|
3
|
0
|
|
Overall Study
Specific Request of Sponsor or Investigator
|
2
|
0
|
1
|
1
|
|
Overall Study
Adverse Event
|
2
|
0
|
1
|
3
|
|
Overall Study
Lack of Efficacy
|
0
|
1
|
6
|
3
|
|
Overall Study
Other
|
8
|
6
|
6
|
4
|
Baseline Characteristics
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).
Baseline characteristics by cohort
| Measure |
Lumateperone 42 mg (ITI-007 60 mg Tosylate)
n=84 Participants
Lumateperone 42 mg (ITI-007 60 mg tosylate) administered for 28 days
Lumateperone 42
|
Lumateperone 84 mg (ITI-007 120 mg Tosylate)
n=83 Participants
Lumateperone 84 mg (ITI-007 120 mg tosylate) administered for 28 days
Lumateperone 84
|
Placebo
n=85 Participants
Placebo: Capsules containing inactive placebo administered for 28 days
|
Risperidone 4 mg
n=82 Participants
Risperidone: Capsules containing 4 mg risperidone administered for 28 days
|
Total
n=334 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
38.3 years
STANDARD_DEVIATION 10.03 • n=84 Participants
|
41.4 years
STANDARD_DEVIATION 8.92 • n=83 Participants
|
40.5 years
STANDARD_DEVIATION 9.83 • n=85 Participants
|
40.7 years
STANDARD_DEVIATION 9.33 • n=82 Participants
|
40.1 years
STANDARD_DEVIATION 9.56 • n=334 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=84 Participants
|
11 Participants
n=83 Participants
|
20 Participants
n=85 Participants
|
9 Participants
n=82 Participants
|
58 Participants
n=334 Participants
|
|
Sex: Female, Male
Male
|
66 Participants
n=84 Participants
|
72 Participants
n=83 Participants
|
65 Participants
n=85 Participants
|
73 Participants
n=82 Participants
|
276 Participants
n=334 Participants
|
|
Race/Ethnicity, Customized
Caucasian/White
|
13 Participants
n=84 Participants
|
16 Participants
n=83 Participants
|
17 Participants
n=85 Participants
|
16 Participants
n=82 Participants
|
62 Participants
n=334 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
70 Participants
n=84 Participants
|
62 Participants
n=83 Participants
|
65 Participants
n=85 Participants
|
64 Participants
n=82 Participants
|
261 Participants
n=334 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=84 Participants
|
0 Participants
n=83 Participants
|
1 Participants
n=85 Participants
|
2 Participants
n=82 Participants
|
3 Participants
n=334 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=84 Participants
|
5 Participants
n=83 Participants
|
3 Participants
n=85 Participants
|
0 Participants
n=82 Participants
|
9 Participants
n=334 Participants
|
|
Positive and Negative Syndrome Scale (PANSS) Total Score
|
88.1 units on a scale
STANDARD_DEVIATION 11.04 • n=76 Participants • 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).
|
84.6 units on a scale
STANDARD_DEVIATION 11.63 • n=80 Participants • 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).
|
86.3 units on a scale
STANDARD_DEVIATION 13.10 • n=80 Participants • 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).
|
86.1 units on a scale
STANDARD_DEVIATION 12.24 • n=75 Participants • 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).
|
86.2 units on a scale
STANDARD_DEVIATION 12.04 • n=311 Participants • 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).
|
PRIMARY outcome
Timeframe: Change from baseline to Day 28Population: 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.
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.
Outcome measures
| Measure |
Lumateperone 42 mg (ITI-007 60 mg Tosylate)
n=76 Participants
Lumateperone 42 mg (ITI-007 60 mg tosylate) administered for 28 days
Lumateperone 42
|
Lumateperone 84 mg (ITI-007 120 mg Tosylate)
n=80 Participants
Lumateperone 84 mg (ITI-007 120 mg tosylate) administered for 28 days
Lumateperone 84
|
Placebo
n=80 Participants
Placebo: Capsules containing inactive placebo administered for 28 days
|
Risperidone 4 mg
n=75 Participants
Risperidone: Capsules containing 4 mg risperidone administered for 28 days
|
|---|---|---|---|---|
|
Change From Baseline to Day 28 in Positive and Negative Syndrome Scale (PANSS) Total Score
|
-13.2 score on a scale
Standard Error 1.7
|
-8.3 score on a scale
Standard Error 1.7
|
-7.4 score on a scale
Standard Error 1.7
|
-13.4 score on a scale
Standard Error 1.7
|
SECONDARY outcome
Timeframe: Change from Baseline to Day 8Population: ITT Population with LOCF
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.
Outcome measures
| Measure |
Lumateperone 42 mg (ITI-007 60 mg Tosylate)
n=76 Participants
Lumateperone 42 mg (ITI-007 60 mg tosylate) administered for 28 days
Lumateperone 42
|
Lumateperone 84 mg (ITI-007 120 mg Tosylate)
n=80 Participants
Lumateperone 84 mg (ITI-007 120 mg tosylate) administered for 28 days
Lumateperone 84
|
Placebo
n=80 Participants
Placebo: Capsules containing inactive placebo administered for 28 days
|
Risperidone 4 mg
n=75 Participants
Risperidone: Capsules containing 4 mg risperidone administered for 28 days
|
|---|---|---|---|---|
|
Change From Baseline to Day 8 in Positive and Negative Syndrome Scale (PANSS) Total Score
|
-4.0 units on a scale
Standard Error 1.2
|
-4.7 units on a scale
Standard Error 1.2
|
-2.6 units on a scale
Standard Error 1.2
|
-6.3 units on a scale
Standard Error 1.2
|
SECONDARY outcome
Timeframe: Change from Baseline to Day 15Population: ITT Population with LOCF
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.
Outcome measures
| Measure |
Lumateperone 42 mg (ITI-007 60 mg Tosylate)
n=76 Participants
Lumateperone 42 mg (ITI-007 60 mg tosylate) administered for 28 days
Lumateperone 42
|
Lumateperone 84 mg (ITI-007 120 mg Tosylate)
n=80 Participants
Lumateperone 84 mg (ITI-007 120 mg tosylate) administered for 28 days
Lumateperone 84
|
Placebo
n=80 Participants
Placebo: Capsules containing inactive placebo administered for 28 days
|
Risperidone 4 mg
n=75 Participants
Risperidone: Capsules containing 4 mg risperidone administered for 28 days
|
|---|---|---|---|---|
|
Change From Baseline to Day 15 in Positive and Negative Syndrome Scale (PANSS) Total Score
|
-7.8 units on a scale
Standard Error 1.4
|
-4.2 units on a scale
Standard Error 1.3
|
-4.5 units on a scale
Standard Error 1.3
|
-9.6 units on a scale
Standard Error 1.4
|
SECONDARY outcome
Timeframe: Change from Baseline to Day 22The 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.
Outcome measures
| Measure |
Lumateperone 42 mg (ITI-007 60 mg Tosylate)
n=76 Participants
Lumateperone 42 mg (ITI-007 60 mg tosylate) administered for 28 days
Lumateperone 42
|
Lumateperone 84 mg (ITI-007 120 mg Tosylate)
n=80 Participants
Lumateperone 84 mg (ITI-007 120 mg tosylate) administered for 28 days
Lumateperone 84
|
Placebo
n=80 Participants
Placebo: Capsules containing inactive placebo administered for 28 days
|
Risperidone 4 mg
n=75 Participants
Risperidone: Capsules containing 4 mg risperidone administered for 28 days
|
|---|---|---|---|---|
|
Change From Baseline to Day 22 in Positive and Negative Syndrome Scale (PANSS) Total Score
|
-10.5 units on a scale
Standard Error 1.6
|
-6.6 units on a scale
Standard Error 1.5
|
-4.6 units on a scale
Standard Error 1.5
|
-10.8 units on a scale
Standard Error 1.6
|
Adverse Events
Lumateperone 42 mg (ITI-007 60 mg Tosylate)
Serious events: 0 serious events
Other events: 39 other events
Deaths: 0 deaths
Lumateperone 84 mg (ITI-007 120 mg Tosylate)
Serious events: 0 serious events
Other events: 52 other events
Deaths: 0 deaths
Placebo
Serious events: 1 serious events
Other events: 28 other events
Deaths: 0 deaths
Risperidone 4 mg
Serious events: 1 serious events
Other events: 37 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Lumateperone 42 mg (ITI-007 60 mg Tosylate)
n=84 participants at risk
Lumateperone 42 mg (ITI-007 60 mg tosylate) administered for 28 days
Lumateperone 42
|
Lumateperone 84 mg (ITI-007 120 mg Tosylate)
n=83 participants at risk
Lumateperone 84 mg (ITI-007 120 mg tosylate) administered for 28 days
Lumateperone 84
|
Placebo
n=85 participants at risk
Placebo: Capsules containing inactive placebo administered for 28 days
|
Risperidone 4 mg
n=82 participants at risk
Risperidone: Capsules containing 4 mg risperidone administered for 28 days
|
|---|---|---|---|---|
|
Psychiatric disorders
Psychotic disorders
|
0.00%
0/84 • From signing ICF until end of study procedures (~ weeks) including 28 days of double-blind treatment.
|
0.00%
0/83 • From signing ICF until end of study procedures (~ weeks) including 28 days of double-blind treatment.
|
0.00%
0/85 • From signing ICF until end of study procedures (~ weeks) including 28 days of double-blind treatment.
|
1.2%
1/82 • Number of events 1 • From signing ICF until end of study procedures (~ weeks) including 28 days of double-blind treatment.
|
|
Psychiatric disorders
Schizophrenia
|
0.00%
0/84 • From signing ICF until end of study procedures (~ weeks) including 28 days of double-blind treatment.
|
0.00%
0/83 • From signing ICF until end of study procedures (~ weeks) including 28 days of double-blind treatment.
|
1.2%
1/85 • Number of events 1 • From signing ICF until end of study procedures (~ weeks) including 28 days of double-blind treatment.
|
0.00%
0/82 • From signing ICF until end of study procedures (~ weeks) including 28 days of double-blind treatment.
|
Other adverse events
| Measure |
Lumateperone 42 mg (ITI-007 60 mg Tosylate)
n=84 participants at risk
Lumateperone 42 mg (ITI-007 60 mg tosylate) administered for 28 days
Lumateperone 42
|
Lumateperone 84 mg (ITI-007 120 mg Tosylate)
n=83 participants at risk
Lumateperone 84 mg (ITI-007 120 mg tosylate) administered for 28 days
Lumateperone 84
|
Placebo
n=85 participants at risk
Placebo: Capsules containing inactive placebo administered for 28 days
|
Risperidone 4 mg
n=82 participants at risk
Risperidone: Capsules containing 4 mg risperidone administered for 28 days
|
|---|---|---|---|---|
|
Nervous system disorders
Sedation
|
7.1%
6/84 • From signing ICF until end of study procedures (~ weeks) including 28 days of double-blind treatment.
|
20.5%
17/83 • From signing ICF until end of study procedures (~ weeks) including 28 days of double-blind treatment.
|
7.1%
6/85 • From signing ICF until end of study procedures (~ weeks) including 28 days of double-blind treatment.
|
6.1%
5/82 • From signing ICF until end of study procedures (~ weeks) including 28 days of double-blind treatment.
|
|
Nervous system disorders
Headache
|
20.2%
17/84 • From signing ICF until end of study procedures (~ weeks) including 28 days of double-blind treatment.
|
18.1%
15/83 • From signing ICF until end of study procedures (~ weeks) including 28 days of double-blind treatment.
|
12.9%
11/85 • From signing ICF until end of study procedures (~ weeks) including 28 days of double-blind treatment.
|
8.5%
7/82 • From signing ICF until end of study procedures (~ weeks) including 28 days of double-blind treatment.
|
|
Nervous system disorders
Somnolence
|
9.5%
8/84 • From signing ICF until end of study procedures (~ weeks) including 28 days of double-blind treatment.
|
13.3%
11/83 • From signing ICF until end of study procedures (~ weeks) including 28 days of double-blind treatment.
|
5.9%
5/85 • From signing ICF until end of study procedures (~ weeks) including 28 days of double-blind treatment.
|
14.6%
12/82 • From signing ICF until end of study procedures (~ weeks) including 28 days of double-blind treatment.
|
|
Nervous system disorders
Dizziness
|
6.0%
5/84 • From signing ICF until end of study procedures (~ weeks) including 28 days of double-blind treatment.
|
9.6%
8/83 • From signing ICF until end of study procedures (~ weeks) including 28 days of double-blind treatment.
|
1.2%
1/85 • From signing ICF until end of study procedures (~ weeks) including 28 days of double-blind treatment.
|
1.2%
1/82 • From signing ICF until end of study procedures (~ weeks) including 28 days of double-blind treatment.
|
|
Nervous system disorders
Akathisia
|
1.2%
1/84 • From signing ICF until end of study procedures (~ weeks) including 28 days of double-blind treatment.
|
2.4%
2/83 • From signing ICF until end of study procedures (~ weeks) including 28 days of double-blind treatment.
|
2.4%
2/85 • From signing ICF until end of study procedures (~ weeks) including 28 days of double-blind treatment.
|
7.3%
6/82 • From signing ICF until end of study procedures (~ weeks) including 28 days of double-blind treatment.
|
|
Gastrointestinal disorders
Nausea
|
7.1%
6/84 • From signing ICF until end of study procedures (~ weeks) including 28 days of double-blind treatment.
|
9.6%
8/83 • From signing ICF until end of study procedures (~ weeks) including 28 days of double-blind treatment.
|
1.2%
1/85 • From signing ICF until end of study procedures (~ weeks) including 28 days of double-blind treatment.
|
4.9%
4/82 • From signing ICF until end of study procedures (~ weeks) including 28 days of double-blind treatment.
|
|
Gastrointestinal disorders
Dry Mouth
|
4.8%
4/84 • From signing ICF until end of study procedures (~ weeks) including 28 days of double-blind treatment.
|
9.6%
8/83 • From signing ICF until end of study procedures (~ weeks) including 28 days of double-blind treatment.
|
2.4%
2/85 • From signing ICF until end of study procedures (~ weeks) including 28 days of double-blind treatment.
|
6.1%
5/82 • From signing ICF until end of study procedures (~ weeks) including 28 days of double-blind treatment.
|
|
Gastrointestinal disorders
Dyspepsia
|
6.0%
5/84 • From signing ICF until end of study procedures (~ weeks) including 28 days of double-blind treatment.
|
1.2%
1/83 • From signing ICF until end of study procedures (~ weeks) including 28 days of double-blind treatment.
|
1.2%
1/85 • From signing ICF until end of study procedures (~ weeks) including 28 days of double-blind treatment.
|
3.7%
3/82 • From signing ICF until end of study procedures (~ weeks) including 28 days of double-blind treatment.
|
|
Investigations
Weight Increased
|
6.0%
5/84 • From signing ICF until end of study procedures (~ weeks) including 28 days of double-blind treatment.
|
6.0%
5/83 • From signing ICF until end of study procedures (~ weeks) including 28 days of double-blind treatment.
|
7.1%
6/85 • From signing ICF until end of study procedures (~ weeks) including 28 days of double-blind treatment.
|
6.1%
5/82 • From signing ICF until end of study procedures (~ weeks) including 28 days of double-blind treatment.
|
|
Investigations
Blood Creatine Phosphokinase Increased
|
8.3%
7/84 • From signing ICF until end of study procedures (~ weeks) including 28 days of double-blind treatment.
|
3.6%
3/83 • From signing ICF until end of study procedures (~ weeks) including 28 days of double-blind treatment.
|
1.2%
1/85 • From signing ICF until end of study procedures (~ weeks) including 28 days of double-blind treatment.
|
9.8%
8/82 • From signing ICF until end of study procedures (~ weeks) including 28 days of double-blind treatment.
|
|
Investigations
Alanine Aminotransferase Increased
|
6.0%
5/84 • From signing ICF until end of study procedures (~ weeks) including 28 days of double-blind treatment.
|
2.4%
2/83 • From signing ICF until end of study procedures (~ weeks) including 28 days of double-blind treatment.
|
1.2%
1/85 • From signing ICF until end of study procedures (~ weeks) including 28 days of double-blind treatment.
|
2.4%
2/82 • From signing ICF until end of study procedures (~ weeks) including 28 days of double-blind treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place