ITI-007 (Lumateperone Tosylate) for Schizophrenia

New York State Psychiatric Institute

Status and phase

Terminated

Phase 2

Conditions

Schizophrenia

Treatments

Drug: ITI-007

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT03817528

7716

Details and patient eligibility

About

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

Full 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.

Enrollment

4 patients

Sex

Male

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

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