Study of a Novel Antipsychotic ITI-007 in Schizophrenia

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

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. The primary goal will be to assess the effects of ITI-007 on psychosis. The safety of ITI-007 will also be assessed.

Study Overview

• Status: Completed
• Conditions: Schizophrenia
• Intervention / Treatment: Drug: ITI-007; Drug: Placebo; Drug: Risperidone

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.

• Study Type: Interventional
• Enrollment (Actual): 335
• Phase: Phase 2

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ITI-007 Low Dose; Lumateperone 42 mg (ITI-007 60 mg tosylate) administered for 28 days	Drug: ITI-007; Capsules containing ITI-007 for 28 days; Drug: Placebo; Capsules containing inactive placebo for 28 days
Experimental: ITI-007 High Dose; Lumateperone 84 mg (ITI-007 120 mg tosylate) administered for 28 days	Drug: ITI-007; Capsules containing ITI-007 for 28 days
Placebo Comparator: Placebo; Placebo: Capsules containing inactive placebo administered for 28 days	Drug: Placebo; Capsules containing inactive placebo for 28 days
Active Comparator: Risperidone; Risperidone: Capsules containing 4 mg risperidone administered for 28 days	Drug: Risperidone; Capsules containing risperidone for 28 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Change from baseline to Day 28

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	Change from Baseline to Day 22

Collaborators and Investigators

• Sponsor: Intra-Cellular Therapies, Inc.
• Investigators: Study Director: Kimberly E Vanover, PhD, Intra-Cellular Therapies

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: December 1, 2011
• Primary Completion (Actual): August 1, 2013
• Study Completion (Actual): November 1, 2013

Study Registration Dates

• First Submitted: December 16, 2011
• First Submitted That Met QC Criteria: December 22, 2011
• First Posted (Estimated): December 26, 2011

Study Record Updates

• Last Update Posted (Estimated): October 3, 2025
• Last Update Submitted That Met QC Criteria: September 16, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Schizophrenia; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines; Pyrimidinones; Risperidone; lumateperone
• Other Study ID Numbers: ITI-007-005