Trial · NCT02469155

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

NCT02469155, Phase 3, Completed, Intra-Cellular Therapies, Inc.; results first posted 2025-10-02

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Trial to Assess the Antipsychotic Efficacy of ITI-007 Over 6 Weeks of Treatment. Trials, record NCT02469155. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02469155

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: A Trial to Assess the Antipsychotic Efficacy of ITI-007 Over 6 Weeks of Treatment
NCT number: NCT02469155
Status: Completed
Phases: Phase 3
Enrollment: 696 participants, actual
Lead sponsor: Intra-Cellular Therapies, Inc.
Conditions: Schizophrenia
Interventions: ITI-007, Risperidone, Placebo
First posted: 2015-06-11
Last updated: 2025-10-02
Results first posted: 2025-10-02

Source ClinicalTrials.gov

Registered outcomes2

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Change From Baseline to Week 6 in Positive and Negative Syndrome Scale (PANSS) Total Score	6 weeks	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	Change From Baseline to Week 6 in Clinical Global Impressions-Severity of Illness Scale	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."

Source ClinicalTrials.gov

Outcomes2

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change From Baseline to Week 6 in Positive and Negative Syndrome Scale (PANSS) Total Score	6 weeks	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.	units on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline to Week 6 in Clinical Global Impressions-Severity of Illness Scale	6 weeks

Source ClinicalTrials.gov

Results by group4

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Change From Baseline to Week 6 in Positive and Negative Syndrome Scale (PANSS) Total Score	Lumateperone 14 mg (ITI-007 20 mg Tosylate)	-15.0	Standard Error 1.27	units on a scale
Change From Baseline to Week 6 in Positive and Negative Syndrome Scale (PANSS) Total Score	Lumateperone 42 mg (ITI-007 60 mg Tosylate)	-14.6	Standard Error 1.23	units on a scale
Change From Baseline to Week 6 in Positive and Negative Syndrome Scale (PANSS) Total Score	Placebo	-15.1	Standard Error 1.21	units on a scale
Change From Baseline to Week 6 in Positive and Negative Syndrome Scale (PANSS) Total Score	Risperidone	-20.5	Standard Error 1.33	units on a scale

Source ClinicalTrials.gov

Participant flow12

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Lumateperone 14 mg (ITI-007 20 mg Tosylate)	174
Overall Study	STARTED	Lumateperone 42 mg (ITI-007 60 mg Tosylate)	174
Overall Study	STARTED	Placebo	174
Overall Study	STARTED	Risperidone	174
Overall Study	COMPLETED	Lumateperone 14 mg (ITI-007 20 mg Tosylate)	113
Overall Study	COMPLETED	Lumateperone 42 mg (ITI-007 60 mg Tosylate)	128
Overall Study	COMPLETED	Placebo	133
Overall Study	COMPLETED	Risperidone	105
Overall Study	NOT COMPLETED	Lumateperone 14 mg (ITI-007 20 mg Tosylate)	61
Overall Study	NOT COMPLETED	Lumateperone 42 mg (ITI-007 60 mg Tosylate)	46

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events40

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Headache	Nervous system disorders	Lumateperone 14 mg (ITI-007 20 mg Tosylate)	16	172
other	Headache	Nervous system disorders	Lumateperone 42 mg (ITI-007 60 mg Tosylate)	36	172
other	Headache	Nervous system disorders	Placebo	25	178
other	Headache	Nervous system disorders	Risperidone	36	173
other	Somnolence	Nervous system disorders	Lumateperone 14 mg (ITI-007 20 mg Tosylate)	19	172
other	Somnolence	Nervous system disorders	Lumateperone 42 mg (ITI-007 60 mg Tosylate)	31	172
other	Somnolence	Nervous system disorders	Placebo	11	178
other	Somnolence	Nervous system disorders	Risperidone	30	173
other	Nausea	Gastrointestinal disorders	Lumateperone 14 mg (ITI-007 20 mg Tosylate)	7	172
other	Nausea	Gastrointestinal disorders	Lumateperone 42 mg (ITI-007 60 mg Tosylate)	16	172

1 to 10 of 40Source ClinicalTrials.gov

See all 40 adverse events

Adverse event totals12

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Lumateperone 14 mg (ITI-007 20 mg Tosylate)	0	172
Total, all-cause mortality	Lumateperone 42 mg (ITI-007 60 mg Tosylate)	0	172
Total, all-cause mortality	Placebo	0	178
Total, all-cause mortality	Risperidone	1	173
Total, other adverse events	Lumateperone 14 mg (ITI-007 20 mg Tosylate)	57	172
Total, other adverse events	Lumateperone 42 mg (ITI-007 60 mg Tosylate)	76	172
Total, other adverse events	Placebo	68	178
Total, other adverse events	Risperidone	79	173
Total, serious adverse events	Lumateperone 14 mg (ITI-007 20 mg Tosylate)	0	172
Total, serious adverse events	Lumateperone 42 mg (ITI-007 60 mg Tosylate)	1	172

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse event totals

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
36883881	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT02469155

GET https://conductscience.org/api/trials/v1/NCT02469155/events?page=2

API reference For AI assistants