Additional Relevant Details
The Phase 3 clinical trial, ITI-007-302, is a randomized, double-blind, placebo- and active-controlled clinical trial in patients with an acutely exacerbated episode of schizophrenia. In this trial, 696 patients were randomized to receive one of four treatments: ITI-007 60 mg, ITI-007 20 mg, risperidone 4 mg (active control) or placebo in a 1:1:1:1 ratio. Patients receive study treatment orally once daily in the morning for 6 weeks. Clinical conduct includes an approximate one-week screening period before randomization followed by the 6-week study treatment period. Prior to discharge from the study, patients are switched to a standard-of-care antipsychotic treatment during a five-day inpatient stabilization period. Patients are instructed to return for an outpatient safety follow-up visit approximately two weeks following the last dose of study treatment (study day 54). The study is being conducted in 13 clinical sites throughout the United States.The primary endpoint for this clinical trial is change from baseline at Day 42 on the Positive and Negative Syndrome Scale (PANSS) total score. The PANSS is a well-validated 30-item rating scale that measures the ability of a drug to reduce schizophrenia symptom severity (Kay et al., 1987, Schizophrenia Bulletin 13:261-276). The PANSS measures positive symptoms, such as delusions, suspiciousness, and hallucinations; negative symptoms, such as blunted affect, social and emotional withdrawal, and stereotyped thinking; and general psychopathology, such as anxiety, tension, depression, and active social avoidance. The key secondary endpoint is change from baseline at Day 42 on the Clinical Global Impression scale for Severity of Illness (CGI-S) that provides a clinician's expert assessment of the patient's overall symptom severity. Additional secondary endpoints and other measures, including safety and tolerability, which may highlight differentiating clinical features of ITI-007 are also being assessed. ITI-007 60 mg has demonstrated a statistically significant improvement versus placebo in schizophrenia symptoms and a favorable safety and tolerability profile in two prior late-stage clinical studies.