Clinical trial NCT03817528: ITI-007 (Lumateperone Tosylate) for Schizophrenia
Official title: ITI-007 (Lumateperone Tosylate) for Schizophrenia
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Schizophrenia
Lead sponsor: New York State Psychiatric Institute
Sponsor class: OTHER
Collaborators: name: Intra-Cellular Therapies, Inc.
First posted: 2019-01-25
Enrollment: 4
Sex: MALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: open-label
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Schizophrenia Symptoms
timeFrame: Change from baseline in Total PANSS score after 6 month treatment
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: New York State Psychiatric Institute
state: New York
Study officials:
affiliation: New York State Psychiatric Institute
name: Jeffrey A Lieberman, MD
role: PRINCIPAL_INVESTIGATOR
References: