SchizophreniaPhase 2NCT01499563

Study of a Novel Antipsychotic ITI-007 in Schizophrenia

A Phase 2 study testing ITI-007 and Risperidone in people with Schizophrenia, run by Intra-Cellular Therapies, Inc. at 8 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 purpose of this study is to evaluate whether ITI-007 is effective in reducing symptoms associated with schizophrenia in patients who are having an acute worsening of their psychosis. Patients will be randomly assigned to receive one of two doses of ITI-007, placebo, or a positive control. Read more about this study

Who is it for?: Ages 18 to 55 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: 335 participants
Where: 8 sitesUnited States
Study dates: Dec 2011to Nov 2013
Phase: Phase 2
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 55 years
All sexes
No healthy volunteers
Adult

Who may be able to join

Patient's age is 18-55
Patient has current diagnosis of schizophrenia and is experiencing an acute exacerbation of psychosis
Patient has a history of at least three months exposure to one or more antipsychotic therapy(ies) and a prior response to antipsychotic therapy within the previous five years

Who cannot join

Any female patient who is pregnant or breast-feeding
Any patient presenting with concurrent dementia, delirium, mental retardation, epilepsy, drug-induced psychosis, or history of significant brain trauma
Any patient presenting with schizoaffective disorder, bipolar disorder, acute mania, or major depression with psychotic features
Any patient considered to be an imminent danger to themselves or others
Any patient with hematological, renal, hepatic, endocrinological, neurological, or cardiovascular disease or substance abuse as defined by protocol
Any patient judged by the Investigator to be inappropriate for the study

Trial locations and contacts

8 sites in 1 country.

City, postcode or hospital

8 sites in 1 country

United States8 sites

Clinical Site
Atlanta, Georgia
Clinical Site
Austin, Texas
Clinical Site
Garden Grove, California
Clinical Site
Little Rock, Arkansas
Clinical Site
Philadelphia, Pennsylvania
Clinical Site
Rockville, Maryland
Clinical Site
St Louis, Missouri
Clinical Site
Willingboro, New Jersey

Other trials in United States

About this study

Official title: A Randomized, Double-blind, Placebo-controlled, Multi-center Study to Assess the Antipsychotic Efficacy of ITI-007 in Patients With Schizophrenia

Read the detailed description

The study will be conducted as a randomized, double-blind, placebo-controlled, multi-center study in patients diagnosed with schizophrenia and an acute exacerbation of psychosis. The efficacy and safety of two dose levels of ITI-007 administered daily for 28 days will be evaluated as compared to placebo; risperidone has been included as a positive control.

Upon completion of the inpatient 28-day Study Treatment Period, patients will be started on standard antipsychotic medication and will be stabilized over a 5-day period before discharge from the study clinic. Patients will be seen for a final outpatient safety evaluation at the End-of-Study visit approximately 2 weeks after discharge.

Conditions: Schizophrenia
Being tested: ITI-007, Placebo, Risperidone
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
Capsules containing ITI-007 for 28 days
PlaceboDrug
Capsules containing inactive placebo for 28 days
RisperidoneDrug
Capsules containing risperidone for 28 days

Study groups in NCT01499563
Study group	Role	What they receive
ITI-007 Low Dose	Experimental	Lumateperone 42 mg (ITI-007 60 mg tosylate) administered for 28 days Receives: Drug: ITI-007; Drug: Placebo
ITI-007 High Dose	Experimental	Lumateperone 84 mg (ITI-007 120 mg tosylate) administered for 28 days Receives: Drug: ITI-007
Placebo	Placebo comparator	Placebo: Capsules containing inactive placebo administered for 28 days Receives: Drug: Placebo
Risperidone	Active comparator	Risperidone: Capsules containing 4 mg risperidone administered for 28 days Receives: Drug: Risperidone

What is being measured

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

Change From Baseline to Day 28 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: Change from baseline to Day 28

Secondary outcomes (3)

Change From Baseline to Day 8 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: Change from Baseline to Day 8
Change From Baseline to Day 15 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: Change from Baseline to Day 15
Change From Baseline to Day 22 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: Change from Baseline to Day 22

Timeline

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

Dec 2011Nov 2013

First posted26 Dec 2011 (estimated)
Study startDec 2011
Primary completionAug 2013
Study completionNov 2013

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 (2)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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 335 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01499563
Sponsor's protocol ID: ITI-007-005
Status last verified: Sep 2025
First submitted: 16 Dec 2011
Last updated: 3 Oct 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

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
Lieberman JA, Davis RE, Correll CU, Goff DC, Kane JM, Tamminga CA, Mates S, Vanover KE. ITI-007 for the Treatment of Schizophrenia: A 4-Week Randomized, Double-Blind, Controlled Trial. Biol Psychiatry. 2016 Jun 15;79(12):952-61. doi: 10.1016/j.biopsych.2015.08.026. Epub 2015 Aug 31.
PubMed 26444072

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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Study at a glance

From the registry record, last updated by the sponsor on 3 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-blind, Placebo-controlled, Multi-center Study to Assess the Antipsychotic Efficacy of ITI-007 in Patients With Schizophrenia
ClinicalTrials.gov ID: NCT01499563
Acronym / sponsor ID: ITI-007-005
Conditions: Schizophrenia
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 335 participants (actual)
Lead sponsor: Intra-Cellular Therapies, Inc.Industry (pharma, biotech, devices)
Study start: Dec 2011
Primary completion: Aug 2013 (actual)
Study completion: Nov 2013 (actual)
First posted: 26 Dec 2011 (estimated)
Results: Posted 3 Oct 2025

Clinical summary

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

Detailed description

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
ITI-007 Low Dose	Experimental	Drug: ITI-007, Drug: PlaceboLumateperone 42 mg (ITI-007 60 mg tosylate) administered for 28 days
ITI-007 High Dose	Experimental	Drug: ITI-007Lumateperone 84 mg (ITI-007 120 mg tosylate) administered for 28 days
Placebo	Placebo comparator	Drug: PlaceboPlacebo: Capsules containing inactive placebo administered for 28 days
Risperidone	Active comparator	Drug: RisperidoneRisperidone: Capsules containing 4 mg risperidone administered for 28 days

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (3 listed)

Patient's age is 18-55
Patient has current diagnosis of schizophrenia and is experiencing an acute exacerbation of psychosis
Patient has a history of at least three months exposure to one or more antipsychotic therapy(ies) and a prior response to antipsychotic therapy within the previous five years

Key exclusion criteria (6 listed)

Any female patient who is pregnant or breast-feeding
Any patient presenting with concurrent dementia, delirium, mental retardation, epilepsy, drug-induced psychosis, or history of significant brain trauma
Any patient presenting with schizoaffective disorder, bipolar disorder, acute mania, or major depression with psychotic features
Any patient considered to be an imminent danger to themselves or others
Any patient with hematological, renal, hepatic, endocrinological, neurological, or cardiovascular disease or substance abuse as defined by protocol

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-007Capsules containing ITI-007 for 28 days	Drug	ITI-007 High Dose, ITI-007 Low Dose
PlaceboCapsules containing inactive placebo for 28 days	Drug	ITI-007 Low Dose, Placebo
RisperidoneCapsules containing risperidone for 28 days	Drug	Risperidone

Primary outcome

Change From Baseline to Day 28 in Positive and Negative Syndrome Scale (PANSS) Total Score
Time frame: Change from baseline to Day 28
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.

3 secondary outcomes

Change From Baseline to Day 8 in Positive and Negative Syndrome Scale (PANSS) Total Score
Time frame: Change from Baseline to Day 8
Change From Baseline to Day 15 in Positive and Negative Syndrome Scale (PANSS) Total Score
Time frame: Change from Baseline to Day 15
Change From Baseline to Day 22 in Positive and Negative Syndrome Scale (PANSS) Total Score
Time frame: Change from Baseline to Day 22

Results and safety

Results posted to the registry on 3 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 42 mg (ITI-007 60 mg Tosylate)	84	60
Lumateperone 84 mg (ITI-007 120 mg Tosylate)	83	64
Placebo	85	61
Risperidone 4 mg	82	63

Primary outcome: Change From Baseline to Day 28 in Positive and Negative Syndrome Scale (PANSS) Total Score

Time frame: Change from baseline to Day 28. Least squares mean (Standard Error). Unit: score on a scale

Measure	Lumateperone 42 mg (ITI-007 60 mg Tosylate) n = 76	Lumateperone 84 mg (ITI-007 120 mg Tosylate) n = 80	Placebo n = 80	Risperidone 4 mg n = 75
Value	-13.2 (1.7)	-8.3 (1.7)	-7.4 (1.7)	-13.4 (1.7)

Lumateperone 42 mg (ITI-007 60 mg Tosylate) vs Placebo: Least Squares Mean Difference: -5.8 (95% CI -11.1 to -0.4), p = 0.017, Mixed Effects model for Repeated Measure
Lumateperone 84 mg (ITI-007 120 mg Tosylate) vs Placebo: Least Squares Mean Difference: -0.9 (95% CI -6.3 to 4.5), p = 0.708, Mixed Effects Model for Repeated Measure

Population analysed: 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.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: From signing ICF until end of study procedures (~ weeks) including 28 days of double-blind treatment.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Lumateperone 42 mg (ITI-007 60 mg Tosylate)	0 of 84 (0%)	39 of 84 (46.4%)	0 of 84
Lumateperone 84 mg (ITI-007 120 mg Tosylate)	0 of 83 (0%)	52 of 83 (62.7%)	0 of 83
Placebo	1 of 85 (1.2%)	28 of 85 (32.9%)	0 of 85
Risperidone 4 mg	1 of 82 (1.2%)	37 of 82 (45.1%)	0 of 82

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 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.
Derived from this study: PubMed 26444072Lieberman JA, Davis RE, Correll CU, Goff DC, Kane JM, Tamminga CA, Mates S, Vanover KE. ITI-007 for the Treatment of Schizophrenia: A 4-Week Randomized, Double-Blind, Controlled Trial. Biol Psychiatry. 2016 Jun 15;79(12):952-61. doi: 10.1016/j.biopsych.2015.08.026. Epub 2015 Aug 31.

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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 E Vanover, PhD study director

Intra-Cellular Therapies

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

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing ITI-007 and Risperidone in people with Schizophrenia, run by Intra-Cellular Therapies, Inc. at 8 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 3 inclusion and 6 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 3 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 8 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 3 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 Day 28 in Positive and Negative Syndrome Scale (PANSS) Total Score (time frame: Change from baseline to Day 28). 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 NCT01499563, which also lists 2 linked publications.

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 3 Oct 2025.