Study of a Novel Antipsychotic ITI-007 in Schizophrenia

NCT01499563 | Completed Phase 2 Results

• 1 other identifier: ITI-007-005
• Study Type: interventional
• Target: 335
• Locations: 1 country
• Sites: 8

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

Conditions

Schizophrenia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Change From Baseline to Day 8 in Positive and Negative Syndrome Scale (PANSS) Total Score

  Change from Baseline to Day 8

• Change From Baseline to Day 15 in Positive and Negative Syndrome Scale (PANSS) Total Score

  Change from Baseline to Day 15

• Change From Baseline to Day 22 in Positive and Negative Syndrome Scale (PANSS) Total Score

  Change from Baseline to Day 22

Study Arms (4)

ITI-007 Low Dose

EXPERIMENTAL

Lumateperone 42 mg (ITI-007 60 mg tosylate) administered for 28 days

Drug: ITI-007; Drug: Placebo

ITI-007 High Dose

EXPERIMENTAL

Lumateperone 84 mg (ITI-007 120 mg tosylate) administered for 28 days

Drug: ITI-007

Placebo

PLACEBO COMPARATOR

Placebo: Capsules containing inactive placebo administered for 28 days

Drug: Placebo

Risperidone

ACTIVE COMPARATOR

Risperidone: Capsules containing 4 mg risperidone administered for 28 days

Drug: Risperidone

Interventions

ITI-007 DRUG

Capsules containing ITI-007 for 28 days

ITI-007 High Dose; ITI-007 Low Dose

Placebo DRUG

Capsules containing inactive placebo for 28 days

ITI-007 Low Dose; Placebo

Risperidone DRUG

Capsules containing risperidone for 28 days

Risperidone

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Intra-Cellular Therapies, Inc.: lead

Study Sites (8)

Clinical Site

Little Rock, Arkansas, United States

Location

Clinical Site

Garden Grove, California, United States

Location

Clinical Site

Atlanta, Georgia, United States

Location

Clinical Site

Rockville, Maryland, United States

Location

Clinical Site

St Louis, Missouri, United States

Location

Clinical Site

Willingboro, New Jersey, United States

Location

Clinical Site

Philadelphia, Pennsylvania, United States

Location

Clinical Site

Austin, Texas, United States

Location

Related Publications (2)

• 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.

  PMID: 36883881 DERIVED

• 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.

  PMID: 26444072 DERIVED

MeSH Terms

Conditions

Schizophrenia

Interventions

lumateperone; Risperidone

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: ITI Clinical Trials
• Organization: Intra-Cellular Therapies, Inc.

ITCIClinialTrials@itci-inc.com

646-440-9333

Study Officials

• Kimberly E Vanover, PhD

  Intra-Cellular Therapies

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2011
• First Posted: December 26, 2011
• Study Start: December 1, 2011
• Primary Completion: August 1, 2013
• Study Completion: November 1, 2013
• Last Updated: October 3, 2025
• Results First Posted: October 3, 2025

Record last verified: 2025-09

Locations

US (8)