Trial Outcomes & Findings for A Trial to Assess the Antipsychotic Efficacy of ITI-007 (NCT NCT02282761)

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

450 participants

Primary outcome timeframe

28 days

Results posted on

2025-10-02

Participant Flow

Participant milestones

Participant milestones
Measure	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	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	Placebo Placebo administered orally as formulated capsules once daily for 28 days Placebo
Overall Study STARTED	150	150	149
Overall Study COMPLETED	120	128	111
Overall Study NOT COMPLETED	30	22	38

Reasons for withdrawal

Reasons for withdrawal
Measure	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	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	Placebo Placebo administered orally as formulated capsules once daily for 28 days Placebo
Overall Study Death	0	0	1
Overall Study Adverse Event	6	2	0
Overall Study Lack of Efficacy	11	6	17
Overall Study Lost to Follow-up	2	2	1
Overall Study Physician Decision	0	0	2
Overall Study Withdrawal by Subject	8	10	16
Overall Study Other	3	2	1

Baseline Characteristics

A Trial to Assess the Antipsychotic Efficacy of ITI-007

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Lumateperone 28 mg (ITI-007 40 mg Tosylate) n=150 Participants Lumateperone 28 mg (ITI-007 40 mg Tosylate) administered orally as formulated capsules once daily for 28 days ITI-007	Lumateperone 42 mg (ITI-007 60 mg Tosylate) n=150 Participants Lumateperone 42 mg (ITI-007 60 mg Tosylate) administered orally as formulated capsules once daily for 28 days ITI-007	Placebo n=149 Participants Placebo administered orally as formulated capsules once daily for 28 days Placebo	Total n=449 Participants Total of all reporting groups
Age, Continuous	43.5 years STANDARD_DEVIATION 10.08 • n=5 Participants	42.4 years STANDARD_DEVIATION 10.30 • n=7 Participants	41.4 years STANDARD_DEVIATION 10.29 • n=5 Participants	42.4 years STANDARD_DEVIATION 10.23 • n=4 Participants
Sex: Female, Male Female	37 Participants n=5 Participants	40 Participants n=7 Participants	26 Participants n=5 Participants	103 Participants n=4 Participants
Sex: Female, Male Male	113 Participants n=5 Participants	110 Participants n=7 Participants	123 Participants n=5 Participants	346 Participants n=4 Participants
Race/Ethnicity, Customized White	42 Participants n=5 Participants	33 Participants n=7 Participants	42 Participants n=5 Participants	117 Participants n=4 Participants
Race/Ethnicity, Customized Black or African American	94 Participants n=5 Participants	108 Participants n=7 Participants	96 Participants n=5 Participants	298 Participants n=4 Participants
Race/Ethnicity, Customized Asian	6 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	8 Participants n=4 Participants
Race/Ethnicity, Customized Other	8 Participants n=5 Participants	8 Participants n=7 Participants	10 Participants n=5 Participants	26 Participants n=4 Participants
Positive and Negative Syndrome Scale (PANSS) total score	89.2 units on a scale STANDARD_DEVIATION 10.13 • n=5 Participants	90.2 units on a scale STANDARD_DEVIATION 9.58 • n=7 Participants	90.6 units on a scale STANDARD_DEVIATION 11.26 • n=5 Participants	90.0 units on a scale STANDARD_DEVIATION 10.34 • n=4 Participants

PRIMARY outcome

Timeframe: 28 days

Outcome measures

Outcome measures
Measure	Lumateperone 28 mg (ITI-007 40 mg Tosylate) n=146 Participants Lumateperone 28 mg (ITI-007 40 mg Tosylate) administered orally as formulated capsules once daily for 28 days ITI-007	Lumateperone 42 mg (ITI-007 60 mg Tosylate) n=148 Participants Lumateperone 42 mg (ITI-007 60 mg Tosylate) administered orally as formulated capsules once daily for 28 days ITI-007	Placebo n=141 Participants Placebo administered orally as formulated capsules once daily for 28 days Placebo
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	-14.5 units on a scale Standard Error 1.25	-10.3 units on a scale Standard Error 1.32

SECONDARY outcome

Timeframe: 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."

Outcome measures

Outcome measures
Measure	Lumateperone 28 mg (ITI-007 40 mg Tosylate) n=146 Participants Lumateperone 28 mg (ITI-007 40 mg Tosylate) administered orally as formulated capsules once daily for 28 days ITI-007	Lumateperone 42 mg (ITI-007 60 mg Tosylate) n=148 Participants Lumateperone 42 mg (ITI-007 60 mg Tosylate) administered orally as formulated capsules once daily for 28 days ITI-007	Placebo n=141 Participants Placebo administered orally as formulated capsules once daily for 28 days Placebo
Change From Baseline to Day 28 in Clinical Global Impressions-Severity of Illness Scale	-0.8 units on a scale Standard Error 0.08	-0.8 units on a scale Standard Error 0.07	-0.5 units on a scale Standard Error 0.08

Adverse Events

Lumateperone 28 mg (ITI-007 40 mg Tosylate)

Serious events: 1 serious events

Other events: 55 other events

Deaths: 0 deaths

Lumateperone 42 mg (ITI-007 60 mg Tosylate)

Serious events: 0 serious events

Other events: 70 other events

Deaths: 0 deaths

Placebo

Serious events: 1 serious events

Other events: 41 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Lumateperone 28 mg (ITI-007 40 mg Tosylate) n=150 participants at risk Lumateperone 28 mg (ITI-007 40 mg Tosylate) administered orally as formulated capsules once daily for 28 days ITI-007	Lumateperone 42 mg (ITI-007 60 mg Tosylate) n=150 participants at risk Lumateperone 42 mg (ITI-007 60 mg Tosylate) administered orally as formulated capsules once daily for 28 days ITI-007	Placebo n=149 participants at risk Placebo administered orally as formulated capsules once daily for 28 days Placebo
Nervous system disorders Convulsion	0.67% 1/150 • From signing ICF until end of study procedures (~49 days), including 28 days of double-blind treatment	0.00% 0/150 • From signing ICF until end of study procedures (~49 days), including 28 days of double-blind treatment	0.00% 0/149 • From signing ICF until end of study procedures (~49 days), including 28 days of double-blind treatment
Respiratory, thoracic and mediastinal disorders Asthma	0.00% 0/150 • From signing ICF until end of study procedures (~49 days), including 28 days of double-blind treatment	0.00% 0/150 • From signing ICF until end of study procedures (~49 days), including 28 days of double-blind treatment	0.67% 1/149 • From signing ICF until end of study procedures (~49 days), including 28 days of double-blind treatment

Other adverse events

Other adverse events
Measure	Lumateperone 28 mg (ITI-007 40 mg Tosylate) n=150 participants at risk Lumateperone 28 mg (ITI-007 40 mg Tosylate) administered orally as formulated capsules once daily for 28 days ITI-007	Lumateperone 42 mg (ITI-007 60 mg Tosylate) n=150 participants at risk Lumateperone 42 mg (ITI-007 60 mg Tosylate) administered orally as formulated capsules once daily for 28 days ITI-007	Placebo n=149 participants at risk Placebo administered orally as formulated capsules once daily for 28 days Placebo
Nervous system disorders Headache	16.0% 24/150 • From signing ICF until end of study procedures (~49 days), including 28 days of double-blind treatment	19.3% 29/150 • From signing ICF until end of study procedures (~49 days), including 28 days of double-blind treatment	14.8% 22/149 • From signing ICF until end of study procedures (~49 days), including 28 days of double-blind treatment
Nervous system disorders Somnolence	11.3% 17/150 • From signing ICF until end of study procedures (~49 days), including 28 days of double-blind treatment	17.3% 26/150 • From signing ICF until end of study procedures (~49 days), including 28 days of double-blind treatment	4.0% 6/149 • From signing ICF until end of study procedures (~49 days), including 28 days of double-blind treatment
Nervous system disorders Sedation	9.3% 14/150 • From signing ICF until end of study procedures (~49 days), including 28 days of double-blind treatment	12.7% 19/150 • From signing ICF until end of study procedures (~49 days), including 28 days of double-blind treatment	5.4% 8/149 • From signing ICF until end of study procedures (~49 days), including 28 days of double-blind treatment
Gastrointestinal disorders Nausea	4.7% 7/150 • From signing ICF until end of study procedures (~49 days), including 28 days of double-blind treatment	10.7% 16/150 • From signing ICF until end of study procedures (~49 days), including 28 days of double-blind treatment	7.4% 11/149 • From signing ICF until end of study procedures (~49 days), including 28 days of double-blind treatment
Gastrointestinal disorders Dry Mouth	6.0% 9/150 • From signing ICF until end of study procedures (~49 days), including 28 days of double-blind treatment	7.3% 11/150 • From signing ICF until end of study procedures (~49 days), including 28 days of double-blind treatment	4.7% 7/149 • From signing ICF until end of study procedures (~49 days), including 28 days of double-blind treatment
Nervous system disorders Dizziness	4.7% 7/150 • From signing ICF until end of study procedures (~49 days), including 28 days of double-blind treatment	6.7% 10/150 • From signing ICF until end of study procedures (~49 days), including 28 days of double-blind treatment	4.0% 6/149 • From signing ICF until end of study procedures (~49 days), including 28 days of double-blind treatment
Gastrointestinal disorders Constipation	4.0% 6/150 • From signing ICF until end of study procedures (~49 days), including 28 days of double-blind treatment	6.7% 10/150 • From signing ICF until end of study procedures (~49 days), including 28 days of double-blind treatment	2.7% 4/149 • From signing ICF until end of study procedures (~49 days), including 28 days of double-blind treatment
Nervous system disorders Fatigue	4.7% 7/150 • From signing ICF until end of study procedures (~49 days), including 28 days of double-blind treatment	5.3% 8/150 • From signing ICF until end of study procedures (~49 days), including 28 days of double-blind treatment	1.3% 2/149 • From signing ICF until end of study procedures (~49 days), including 28 days of double-blind treatment

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