A Trial to Assess the Antipsychotic Efficacy of ITI-007
- Registration Number
- NCT02282761
- Lead Sponsor
- Intra-Cellular Therapies, Inc.
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 450
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 60 mg ITI-007 ITI-007 60 mg ITI-007 administered orally as formulated capsules once daily for 28 days 40 mg ITI-007 ITI-007 40 mg ITI-007 administered orally as formulated capsules once daily for 28 days Placebo Placebo Placebo administered orally as formulated capsules once daily for 28 days
- Primary Outcome Measures
Name Time Method Positive and Negative Syndrome Scale Total Score 28 days
- Secondary Outcome Measures
Name Time Method Positive and Negative Syndrome Scale Subscales 28 days
Trial Locations
- Locations (1)
Clinical Site
🇺🇸Long Beach, California, United States