Study of a Novel Antipsychotic ITI-007 in Schizophrenia

The study will be conducted as a randomized, double-blind, placebo-controlled, multi-center
study in patients diagnosed with schizophrenia and an acute exacerbation of psychosis. The
efficacy and safety of two dose levels of ITI-007 administered daily for 28 days will be
evaluated as compared to placebo; risperidone has been included as a positive control.

Upon completion of the inpatient 28-day Study Treatment Period, patients will be started on
standard antipsychotic medication and will be stabilized over a 5-day period before
discharge from the study clinic. Patients will be seen for a final outpatient safety
evaluation at the End-of-Study visit approximately 2 weeks after discharge.

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