Study of a Novel Antipsychotic ITI-007 in Schizophrenia

• Status: Completed
• Trial end date: 2013-11-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate whether ITI-007 is effective in reducing symptoms associated with schizophrenia in patients who are having an acute worsening of their psychosis. Patients will be randomly assigned to receive one of two doses of ITI-007, placebo, or a positive control. The primary goal will be to assess the effects of ITI-007 on psychosis. The safety of ITI-007 will also be assessed.

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

Details

• Lead Sponsor: Intra-Cellular Therapies, Inc.
• Treatments: Antipsychotic Agents; Risperidone

Criteria

Inclusion Criteria:

• Patient's age is 18-55

• Patient has current diagnosis of schizophrenia and is experiencing an acute exacerbation of psychosis

• Patient has a history of at least three months exposure to one or more antipsychotic therapy(ies) and a prior response to antipsychotic therapy within the previous five years

Exclusion Criteria:

• Any female patient who is pregnant or breast-feeding

• Any patient presenting with concurrent dementia, delirium, mental retardation, epilepsy, drug-induced psychosis, or history of significant brain trauma

• Any patient presenting with schizoaffective disorder, bipolar disorder, acute mania, or major depression with psychotic features

• Any patient considered to be an imminent danger to themselves or others

• Any patient with hematological, renal, hepatic, endocrinological, neurological, or cardiovascular disease or substance abuse as defined by protocol

• Any patient judged by the Investigator to be inappropriate for the study