A Trial to Assess the Antipsychotic Efficacy of ITI-007

The study will be conducted as a randomized, double-blind, parallel-group, placebo-controlled, multi-center study in patients diagnosed with schizophrenia having an acute exacerbation of psychosis.


Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Assess the Antipsychotic Efficacy of ITI-007 in Patients With Schizophrenia
Enrollment: 450
Study Start Date: November 2014
Study Completion Date: September 2015
Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)

Arms:
- Experimental: 40 mg ITI-007
- Experimental: 60 mg ITI-007
- Placebo Comparator: Placebo