ITI-007 (Lumateperone Tosylate) for Schizophrenia

• Status: Terminated
• Trial end date: 2020-09-23
• Target enrollment: 0
• Participant gender: Male

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: New York State Psychiatric Institute
• Collaborator: Intra-Cellular Therapies, Inc.

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