Schizophrenia Clinical Trial
Official title:
A Randomized, Double-blind, Placebo-controlled, Multi-center Study to Assess the Antipsychotic Efficacy of ITI-007 in Patients With Schizophrenia
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.
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.
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