Status:
TERMINATED
ITI-007 (Lumateperone Tosylate) for Schizophrenia
Lead Sponsor:
New York State Psychiatric Institute
Collaborating Sponsors:
Intra-Cellular Therapies, Inc.
Conditions:
Schizophrenia
Eligibility:
MALE
18-60 years
Phase:
PHASE2
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 w...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 23 2020
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT03817528
Start Date
March 1 2019
End Date
September 23 2020
Last Update
November 4 2021
Active Locations (1)
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1
New York State Psychiatric Institute
New York, New York, United States, 10032