Trial Outcomes & Findings for A Trial to Assess the Antipsychotic Efficacy of ITI-007 Over 6 Weeks of Treatment (NCT NCT02469155)

Last Updated: 2025-10-02

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

PHASE3

Target enrollment

696 participants

Primary outcome timeframe

6 weeks

Results posted on

2025-10-02

Participant Flow

Participant milestones

Participant milestones
Measure	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	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	Placebo Placebo administered orally as visually-matched capsules once daily for 6 weeks Placebo	Risperidone Risperidone administered orally as visually-matched over-encapsulated tablet once daily for 6 weeks Risperidone
Overall Study STARTED	174	174	174	174
Overall Study COMPLETED	113	128	133	105
Overall Study NOT COMPLETED	61	46	41	69

Reasons for withdrawal

Reasons for withdrawal
Measure	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	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	Placebo Placebo administered orally as visually-matched capsules once daily for 6 weeks Placebo	Risperidone Risperidone administered orally as visually-matched over-encapsulated tablet once daily for 6 weeks Risperidone
Overall Study Adverse Event	6	0	1	10
Overall Study Lack of Efficacy	13	10	10	8
Overall Study Death	0	0	0	1
Overall Study Lost to Follow-up	5	2	7	2
Overall Study Physician Decision	0	0	1	0
Overall Study Withdrawal by Subject	34	30	20	37
Overall Study Other	3	3	2	10
Overall Study Protocol Violation	0	1	0	1

Baseline Characteristics

A Trial to Assess the Antipsychotic Efficacy of ITI-007 Over 6 Weeks of Treatment

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Lumateperone 14 mg (ITI-007 20 mg Tosylate) n=172 Participants Lumateperone 14 mg (ITI-007 20 mg Tosylate) administered orally as formulated capsules once daily for 6 weeks ITI-007	Lumateperone 42 mg (ITI-007 60 mg Tosylate) n=172 Participants Lumateperone 42 mg (ITI-007 60 mg Tosylate) administered orally as formulated capsules once daily for 6 weeks ITI-007	Placebo n=178 Participants Placebo administered orally as visually-matched capsules once daily for 6 weeks Placebo	Risperidone n=173 Participants Risperidone administered orally as visually-matched over-encapsulated tablet once daily for 6 weeks Risperidone	Total n=695 Participants Total of all reporting groups
Age, Continuous	42.7 years STANDARD_DEVIATION 9.99 • n=5 Participants	41.9 years STANDARD_DEVIATION 9.88 • n=7 Participants	43.5 years STANDARD_DEVIATION 9.90 • n=5 Participants	42.4 years STANDARD_DEVIATION 10.77 • n=4 Participants	42.6 years STANDARD_DEVIATION 10.13 • n=21 Participants
Sex: Female, Male Female	47 Participants n=5 Participants	49 Participants n=7 Participants	46 Participants n=5 Participants	41 Participants n=4 Participants	183 Participants n=21 Participants
Sex: Female, Male Male	125 Participants n=5 Participants	123 Participants n=7 Participants	132 Participants n=5 Participants	132 Participants n=4 Participants	512 Participants n=21 Participants
Race/Ethnicity, Customized White	26 Participants n=5 Participants	30 Participants n=7 Participants	35 Participants n=5 Participants	40 Participants n=4 Participants	131 Participants n=21 Participants
Race/Ethnicity, Customized Back or African American	140 Participants n=5 Participants	140 Participants n=7 Participants	133 Participants n=5 Participants	123 Participants n=4 Participants	536 Participants n=21 Participants
Race/Ethnicity, Customized Asian	2 Participants n=5 Participants	0 Participants n=7 Participants	3 Participants n=5 Participants	2 Participants n=4 Participants	7 Participants n=21 Participants
Race/Ethnicity, Customized Other	4 Participants n=5 Participants	2 Participants n=7 Participants	7 Participants n=5 Participants	8 Participants n=4 Participants	21 Participants n=21 Participants
Positive and Negative Syndrome Scale (PANSS) Total Score	88.7 units on a scale STANDARD_DEVIATION 9.86 • n=5 Participants	90.9 units on a scale STANDARD_DEVIATION 10.26 • n=7 Participants	90.0 units on a scale STANDARD_DEVIATION 9.81 • n=5 Participants	90.0 units on a scale STANDARD_DEVIATION 9.60 • n=4 Participants	89.9 units on a scale STANDARD_DEVIATION 9.89 • n=21 Participants

PRIMARY outcome

Timeframe: 6 weeks

Population: 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.

Outcome measures

Outcome measures
Measure	Lumateperone 14 mg (ITI-007 20 mg Tosylate) n=166 Participants Lumateperone 14 mg (ITI-007 20 mg Tosylate) administered orally as formulated capsules once daily for 6 weeks ITI-007	Lumateperone 42 mg (ITI-007 60 mg Tosylate) n=162 Participants Lumateperone 42 mg (ITI-007 60 mg Tosylate) administered orally as formulated capsules once daily for 6 weeks ITI-007	Placebo n=169 Participants Placebo administered orally as visually-matched capsules once daily for 6 weeks Placebo	Risperidone n=157 Participants Risperidone administered orally as visually-matched over-encapsulated tablet once daily for 6 weeks Risperidone
Change From Baseline to Week 6 in Positive and Negative Syndrome Scale (PANSS) Total Score	-15.0 units on a scale Standard Error 1.27	-14.6 units on a scale Standard Error 1.23	-15.1 units on a scale Standard Error 1.21	-20.5 units on a scale Standard Error 1.33

SECONDARY outcome

Timeframe: 6 weeks

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."

Outcome measures

Outcome data not reported

Adverse Events

Lumateperone 14 mg (ITI-007 20 mg Tosylate)

Serious events: 0 serious events

Other events: 57 other events

Deaths: 0 deaths

Lumateperone 42 mg (ITI-007 60 mg Tosylate)

Serious events: 1 serious events

Other events: 76 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 68 other events

Deaths: 0 deaths

Risperidone

Serious events: 0 serious events

Other events: 79 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Lumateperone 14 mg (ITI-007 20 mg Tosylate) n=172 participants at risk Lumateperone 14 mg (ITI-007 20 mg Tosylate) administered orally as formulated capsules once daily for 6 weeks ITI-007	Lumateperone 42 mg (ITI-007 60 mg Tosylate) n=172 participants at risk Lumateperone 42 mg (ITI-007 60 mg Tosylate) administered orally as formulated capsules once daily for 6 weeks ITI-007	Placebo n=178 participants at risk Placebo administered orally as visually-matched capsules once daily for 6 weeks Placebo	Risperidone n=173 participants at risk Risperidone administered orally as visually-matched over-encapsulated tablet once daily for 6 weeks Risperidone
Psychiatric disorders Agitation	0.00% 0/172 • 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.	0.58% 1/172 • 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.	0.00% 0/178 • 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.	0.00% 0/173 • 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.

Other adverse events

Other adverse events
Measure	Lumateperone 14 mg (ITI-007 20 mg Tosylate) n=172 participants at risk Lumateperone 14 mg (ITI-007 20 mg Tosylate) administered orally as formulated capsules once daily for 6 weeks ITI-007	Lumateperone 42 mg (ITI-007 60 mg Tosylate) n=172 participants at risk Lumateperone 42 mg (ITI-007 60 mg Tosylate) administered orally as formulated capsules once daily for 6 weeks ITI-007	Placebo n=178 participants at risk Placebo administered orally as visually-matched capsules once daily for 6 weeks Placebo	Risperidone n=173 participants at risk Risperidone administered orally as visually-matched over-encapsulated tablet once daily for 6 weeks Risperidone
Nervous system disorders Headache	9.3% 16/172 • 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.	20.9% 36/172 • 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.	14.0% 25/178 • 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.	20.8% 36/173 • 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.
Nervous system disorders Somnolence	11.0% 19/172 • 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.	18.0% 31/172 • 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.	6.2% 11/178 • 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.	17.3% 30/173 • 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.
Gastrointestinal disorders Nausea	4.1% 7/172 • 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.	9.3% 16/172 • 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.	4.5% 8/178 • 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.	8.7% 15/173 • 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.
Gastrointestinal disorders Constipation	5.8% 10/172 • 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.	7.0% 12/172 • 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.	9.6% 17/178 • 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.	4.0% 7/173 • 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.
Gastrointestinal disorders Dyspepsia	3.5% 6/172 • 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.	5.2% 9/172 • 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.	5.6% 10/178 • 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.	1.7% 3/173 • 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.
Gastrointestinal disorders Dry Mouth	2.3% 4/172 • 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.	5.2% 9/172 • 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.	0.00% 0/178 • 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.	4.0% 7/173 • 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.
Nervous system disorders Sedation	6.4% 11/172 • 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.	4.1% 7/172 • 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.	2.8% 5/178 • 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.	8.1% 14/173 • 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.
Gastrointestinal disorders Toothache	2.9% 5/172 • 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.	4.1% 7/172 • 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.	6.2% 11/178 • 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.	4.6% 8/173 • 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.
Investigations Weight Increased	2.9% 5/172 • 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.	1.7% 3/172 • 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.	2.2% 4/178 • 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.	6.4% 11/173 • 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.

Additional Information

ITI Clinical Trials

Intra-Cellular Therapies, Inc.

Phone: 646-440-9333

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place