ITI-007 (Lumateperone Tosylate) for Schizophrenia

The purpose of this study is to offer open label ITI-007 treatment to patients who poorly respond or poorly tolerate approved medications.

Study Overview

• Status: Terminated
• Conditions: Schizophrenia
• Intervention / Treatment: Drug: ITI-007

Detailed Description

Patients will be started on ITI-007 and current medication will be slowly discontinued within the first 7 days of starting ITI-007, with some flexibility allowed if clinically indicated. No patients will be left unmedicated because of this study.

Patients will be seen weekly for the first 4 weeks, biweekly for the second month and then monthly for six months. Patients will be monitored by clinical and safety rating scales, and will be required to show improvement after 3 months to remain in this study. Patients not improving at this time will be assessed for the risks/benefits of continuing.

• Study Type: Interventional
• Enrollment (Actual): 4
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10032
      • New York State Psychiatric Institute

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5) diagnosis of schizophrenia or schizoaffective disorder
• Has capacity to provide informed consent
• Medically stable for study participation
• Judged clinically not to be at significant suicide or violence risk
• Inadequate response or tolerability to previously antipsychotic therapy, as defined by at least one of the following: prior clozapine failure, a PANSS>80 despite at least six weeks of a current antipsychotic therapy, a Clinical Global Impressions scale-Improvement (CGI-I) of 4 after at least two six week trials of antipsychotics (retrospective assessment) or failure to tolerate an adequate dose of at least antipsychotics (as defined by the Physicians Desk Reference)

Exclusion Criteria:

• Substance abuse within last 90 days
• ECG abnormality that is clinically significant
• Pregnancy, lactation, or lack of use of effective birth control
• Presence or positive history of significant unstable medical or neurological illness (including any history of seizure disorder, hepatitis, renal insufficiency or mental retardation), history of HIV
• Clinically significant abnormal laboratory tests, positive for hepatitis B or C or liver function tests (LFTs) > 2x Upper Limit of Normal, use of strong CYP3A4 inhibitors or inducers
• History or presence of concomitant major psychiatric illness.
• Use of other antipsychotic medications at baseline.
• Use of another investigational medication in the previous 4 weeks

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ITI-007; Open-Label ITI-007 40-60 mg	Drug: ITI-007; ITI-007 (Lumateperone tosylate)dosed 40-60 mg based on efficacy/adverse events; Other Names: Lumateperone tosylate

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Schizophrenia Symptoms	schizophrenia symptoms will be measures using the Positive and Negative Symptom Scale (PANSS) Total PANSS score (range: 30-210). Individual items scored from 1(absent) to 7 (extremely severe). Total PANSS score is sum of the 30 individual items with lowest score (30) indicating all symptoms absent and the maximum score (210) indicating all symptoms rated as extremely severe.	Change from baseline in Total PANSS score after 6 month treatment

Collaborators and Investigators

• Sponsor: New York State Psychiatric Institute
• Collaborators: Intra-Cellular Therapies, Inc.
• Investigators: Principal Investigator: Jeffrey A Lieberman, MD, New York State Psychiatric Institute

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2019
• Primary Completion (Actual): September 23, 2020
• Study Completion (Actual): September 23, 2020

Study Registration Dates

• First Submitted: November 30, 2018
• First Submitted That Met QC Criteria: January 23, 2019
• First Posted (Actual): January 25, 2019

Study Record Updates

• Last Update Posted (Actual): November 4, 2021
• Last Update Submitted That Met QC Criteria: November 2, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia
• Other Study ID Numbers: 7716

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No