ITI-007 (Lumateperone Tosylate) for Schizophrenia

NCT ID: NCT03817528

Last Updated: 2021-11-04

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 4 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-01
• Study Completion Date: 2020-09-23

Brief Summary

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

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.

Conditions

Schizophrenia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ITI-007

Open-Label ITI-007 40-60 mg

Group Type: EXPERIMENTAL

ITI-007

Intervention Type: DRUG

ITI-007 (Lumateperone tosylate)dosed 40-60 mg based on efficacy/adverse events

Interventions

ITI-007

ITI-007 (Lumateperone tosylate)dosed 40-60 mg based on efficacy/adverse events

Intervention Type: DRUG

Other Intervention Names

Lumateperone tosylate

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Intra-Cellular Therapies, Inc.

INDUSTRY

Sponsor Role: collaborator

New York State Psychiatric Institute

OTHER

Sponsor Role: lead

Responsible Party

Jeffrey A. Lieberman, MD

Director, New York State Psychiatric Institute

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jeffrey A Lieberman, MD

Role: PRINCIPAL_INVESTIGATOR

New York State Psychiatric Institute

Locations

New York State Psychiatric Institute

New York, New York, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Other Identifiers

7716

Identifier Type: -

Identifier Source: org_study_id