A Trial to Assess the Antipsychotic Efficacy of ITI-007 Over 6 Weeks of Treatment

• Status: Completed
• Trial end date: 2016-08-01
• Target enrollment: 0
• Participant gender: All

Summary

The study will evaluate the antipsychotic efficacy of ITI-007 in a randomized, double-blind, parallel-group, placebo- and active-controlled, multi-center study in patients diagnosed with schizophrenia having an acute exacerbation of psychosis.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

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

Criteria

Inclusion Criteria:

• male or female subjects of any race, ages 18-60 inclusive, with a clinical diagnosis of schizophrenia

• experiencing an acute exacerbation of psychosis

Exclusion Criteria:

• any subject unable to provide informed consent

• any female subject who is pregnant or breast-feeding

• any subject judged to be medically inappropriate for study participation