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ITI-007 (Lumateperone Tosylate) for Schizophrenia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03817528
Recruitment Status : Suspended (This study is temporarily suspended due to COVID-19 pandemic.)
First Posted : January 25, 2019
Last Update Posted : April 20, 2020
Intra-Cellular Therapies, Inc.
Information provided by (Responsible Party):
Jeffrey A. Lieberman, MD, New York State Psychiatric Institute

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.

Condition or disease Intervention/treatment Phase
Schizophrenia Drug: ITI-007 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: open-label
Masking: None (Open Label)
Masking Description: None (open label)
Primary Purpose: Treatment
Official Title: ITI-007 (Lumateperone Tosylate) for Schizophrenia
Actual Study Start Date : March 1, 2019
Estimated Primary Completion Date : January 1, 2021
Estimated Study Completion Date : March 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

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 Name: Lumateperone tosylate

Primary Outcome Measures :
  1. Schizophrenia symptoms [ Time Frame: Change from baseline in Total PANSS score after 6 month treatment ]
    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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03817528

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United States, New York
New York State Psychiatric Institute
New York, New York, United States, 10032
Sponsors and Collaborators
New York State Psychiatric Institute
Intra-Cellular Therapies, Inc.
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Principal Investigator: Jeffrey A Lieberman, MD New York State Psychiatric Institute
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Responsible Party: Jeffrey A. Lieberman, MD, Director, New York State Psychiatric Institute, New York State Psychiatric Institute Identifier: NCT03817528    
Other Study ID Numbers: 7716
First Posted: January 25, 2019    Key Record Dates
Last Update Posted: April 20, 2020
Last Verified: April 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders