SchizophreniaPhase 3NCT02469155

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

A Phase 3 study testing ITI-007 and Risperidone in people with Schizophrenia, run by Intra-Cellular Therapies, Inc. at 11 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The study will evaluate the antipsychotic efficacy of ITI-007 in a randomized, double-blind, parallel-group, placebo- and active-controlled, multi-center study in patients diagnosed with schizophrenia having an acute exacerbation of psychosis. Read more about this study

Who is it for?: Ages 18 to 60 years
Conditions the study is for: Schizophrenia
What is being tested?: ITI-007 and Risperidone
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 696 participants
Where: 11 sitesUnited States
Study dates: Jun 2015to Aug 2016
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 60 years
All sexes
No healthy volunteers
Adult

Who may be able to join

male or female subjects of any race, ages 18-60 inclusive, with a clinical diagnosis of schizophrenia
experiencing an acute exacerbation of psychosis

Who cannot join

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

Trial locations and contacts

11 sites in 1 country.

City, postcode or hospital

11 sites in 1 country

United States11 sites

Clinical Site
Austin, Texas
Clinical Site
Berlin, New Jersey
Clinical Site
Culver City, California
Clinical Site
Dallas, Texas
Clinical Site
Lemon Grove, California
Clinical Site
Little Rock, Arkansas
Clinical Site
Long Beach, California
Clinical Site
Marlton, New Jersey
Clinical Site
North Miami, Florida
Clinical Site
San Diego, California
Clinical Site
Springdale, Arkansas

Other trials in United States

About this study

Official title: A Randomized, Double-Blind, Placebo- and Active-Controlled, Multi-Center Study to Assess the Antipsychotic Efficacy of ITI-007 After 6 Weeks of Treatment in Patients With Schizophrenia

Conditions: Schizophrenia
Being tested: ITI-007, Risperidone, Placebo
Medical subject headings: Schizophrenia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ITI-007Drug
RisperidoneDrug
PlaceboDrug

Study groups in NCT02469155
Study group	Role	What they receive
Lumateperone 14 mg (ITI-007 20 mg Tosylate)	Experimental	Lumateperone 14 mg (ITI-007 20 mg Tosylate) administered orally as formulated capsules once daily for 6 weeks Receives: Drug: ITI-007
Lumateperone 42 mg (ITI-007 60 mg Tosylate)	Experimental	Lumateperone 42 mg (ITI-007 60 mg Tosylate) administered orally as formulated capsules once daily for 6 weeks Receives: Drug: ITI-007
Placebo	Placebo comparator	Placebo administered orally as visually-matched capsules once daily for 6 weeks Receives: Drug: Placebo
Risperidone	Active comparator	Risperidone administered orally as visually-matched over-encapsulated tablet once daily for 6 weeks Receives: Drug: Risperidone

What is being measured

The primary outcome is the main question the study is designed to answer.

Change From Baseline to Week 6 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.
Measured: 6 weeks

Secondary outcomes (1)

Change From Baseline to Week 6 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."
Measured: 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2015Aug 2016

First posted11 Jun 2015 (estimated)
Study startJun 2015
Primary completionAug 2016
Study completionAug 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for SchizophreniaStudies of the same condition, open and under way.
More trials run by Intra-Cellular Therapies, Inc.The sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 696 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02469155
Sponsor's protocol ID: ITI-007-302
Status last verified: Sep 2025
First submitted: 9 Jun 2015
Last updated: 2 Oct 2025
Results posted: Yes, on ClinicalTrials.gov

Publications

Citrome L, Durgam S, Edwards JB, Davis RE. Lumateperone for the Treatment of Schizophrenia: Number Needed to Treat, Number Needed to Harm, and Likelihood to Be Helped or Harmed. J Clin Psychiatry. 2023 Mar 6;84(2):22r14631. doi: 10.4088/JCP.22r14631.
PubMed 36883881

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Schizophrenia trials

Study at a glance

From the registry record, last updated by the sponsor on 2 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-Blind, Placebo- and Active-Controlled, Multi-Center Study to Assess the Antipsychotic Efficacy of ITI-007 After 6 Weeks of Treatment in Patients With Schizophrenia
ClinicalTrials.gov ID: NCT02469155
Acronym / sponsor ID: ITI-007-302
Conditions: Schizophrenia
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 696 participants (actual)
Lead sponsor: Intra-Cellular Therapies, Inc.Industry (pharma, biotech, devices)
Study start: Jun 2015
Primary completion: Aug 2016 (actual)
Study completion: Aug 2016 (actual)
First posted: 11 Jun 2015 (estimated)
Results: Posted 2 Oct 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
Lumateperone 14 mg (ITI-007 20 mg Tosylate)	Experimental	Drug: ITI-007Lumateperone 14 mg (ITI-007 20 mg Tosylate) administered orally as formulated capsules once daily for 6 weeks
Lumateperone 42 mg (ITI-007 60 mg Tosylate)	Experimental	Drug: ITI-007Lumateperone 42 mg (ITI-007 60 mg Tosylate) administered orally as formulated capsules once daily for 6 weeks
Placebo	Placebo comparator	Drug: PlaceboPlacebo administered orally as visually-matched capsules once daily for 6 weeks
Risperidone	Active comparator	Drug: RisperidoneRisperidone administered orally as visually-matched over-encapsulated tablet once daily for 6 weeks

Who may qualify

Ages: 18 to 60 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (2 listed)

male or female subjects of any race, ages 18-60 inclusive, with a clinical diagnosis of schizophrenia
experiencing an acute exacerbation of psychosis

Key exclusion criteria (3 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
ITI-007	Drug	Lumateperone 14 mg (ITI-007 20 mg Tosylate), Lumateperone 42 mg (ITI-007 60 mg Tosylate)
Risperidone	Drug	Risperidone
Placebo	Drug	Placebo

Primary outcome

Change From Baseline to Week 6 in Positive and Negative Syndrome Scale (PANSS) Total Score
Time frame: 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.

1 secondary outcome

Change From Baseline to Week 6 in Clinical Global Impressions-Severity of Illness Scale
Time frame: 6 weeks

Results and safety

Results posted to the registry on 2 Oct 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Lumateperone 14 mg (ITI-007 20 mg Tosylate)	174	113
Lumateperone 42 mg (ITI-007 60 mg Tosylate)	174	128
Placebo	174	133
Risperidone	174	105

Primary outcome: Change From Baseline to Week 6 in Positive and Negative Syndrome Scale (PANSS) Total Score

Time frame: 6 weeks. Least squares mean (Standard Error). Unit: units on a scale

Measure	Lumateperone 14 mg (ITI-007 20 mg Tosylate) n = 166	Lumateperone 42 mg (ITI-007 60 mg Tosylate) n = 162	Placebo n = 169	Risperidone n = 157
Value	-15.0 (1.27)	-14.6 (1.23)	-15.1 (1.21)	-20.5 (1.33)

Lumateperone 14 mg (ITI-007 20 mg Tosylate) vs Placebo: Least Squares Mean Difference: 0.1 (95% CI -3.39 to 3.51), p = 0.972, Mixed Models for Repeated Measure
Lumateperone 42 mg (ITI-007 60 mg Tosylate) vs Placebo: Least Squares Mean Difference: 0.5 (95% CI -2.92 to 3.84), p = 0.789, Mixed Effects Model for Repeated Measure

Population analysed: 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.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: From signing ICF until end of study procedures (~10 weeks), including 6 weeks of double blind treatment.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Lumateperone 14 mg (ITI-007 20 mg Tosylate)	0 of 172 (0%)	57 of 172 (33.1%)	0 of 172
Lumateperone 42 mg (ITI-007 60 mg Tosylate)	1 of 172 (0.6%)	76 of 172 (44.2%)	0 of 172
Placebo	0 of 178 (0%)	68 of 178 (38.2%)	0 of 178
Risperidone	0 of 173 (0%)	79 of 173 (45.7%)	1 of 173

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 36883881Citrome L, Durgam S, Edwards JB, Davis RE. Lumateperone for the Treatment of Schizophrenia: Number Needed to Treat, Number Needed to Harm, and Likelihood to Be Helped or Harmed. J Clin Psychiatry. 2023 Mar 6;84(2):22r14631. doi: 10.4088/JCP.22r14631.

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Not yet recruiting
Deep Brain Stimulation for Treatment-Resistant Schizophrenia
Treatment Resistant Disorders
Not yet recruitingObservational study
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Kimberly Vanover, Ph.D. study director

Intra-Cellular Therapies, Inc.

11 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing ITI-007 and Risperidone in people with Schizophrenia, run by Intra-Cellular Therapies, Inc. at 11 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 2 Oct 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline to Week 6 in Positive and Negative Syndrome Scale (PANSS) Total Score (time frame: 6 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02469155, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2025.