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

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

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.

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 696
• Phase: Phase 3

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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."	6 weeks

Collaborators and Investigators

• Sponsor: Intra-Cellular Therapies, Inc.
• Investigators: Study Director: Kimberly Vanover, Ph.D., Intra-Cellular Therapies, Inc.

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start: June 1, 2015
• Primary Completion (Actual): August 1, 2016
• Study Completion (Actual): August 1, 2016

Study Registration Dates

• First Submitted: June 9, 2015
• First Submitted That Met QC Criteria: June 10, 2015
• First Posted (Estimated): June 11, 2015

Study Record Updates

• Last Update Posted (Estimated): October 2, 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-007-302