ITI-007 (Lumateperone Tosylate) for Schizophrenia

Phase 2

Terminated

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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
ITI-007	ITI-007	Open-Label ITI-007 40-60 mg

Primary Outcome Measures

Name	Time	Method
Schizophrenia Symptoms	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.

Secondary Outcome Measures

Name	Time	Method

Locations (1): New York State Psychiatric Institute
🇺🇸
New York, New York, United States
New York State Psychiatric Institute
🇺🇸New York, New York, United States