NCT01499563

Study of a Novel Antipsychotic ITI-007 in Schizophrenia

A Randomized, Double-blind, Placebo-controlled, Multi-center Study to Assess the Antipsychotic Efficacy of ITI-007 in Patients With Schizophrenia

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 335 (actual)
• Sponsor: Intra-Cellular Therapies, Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Schizophrenia

Interventions

Type	Name	Description
DRUG	ITI-007	Capsules containing ITI-007 for 28 days
DRUG	Placebo	Capsules containing inactive placebo for 28 days
DRUG	Risperidone	Capsules containing risperidone for 28 days

Timeline

• Start date: 2011-12-01
• Primary completion: 2013-08-01
• Completion: 2013-11-01
• First posted: 2011-12-26
• Last updated: 2025-10-03
• Results posted: 2025-10-03

Locations

8 sites across 1 country: United States