A Trial to Assess the Antipsychotic Efficacy of ITI-007 Over 6 Weeks of Treatment
- Registration Number
- NCT02469155
- Lead Sponsor
- Intra-Cellular Therapies, Inc.
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 696
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 6 weeks Risperidone Risperidone Risperidone administered orally as visually-matched over-encapsulated tablet once daily for 6 weeks Placebo Placebo Placebo administered orally as visually-matched capsules once daily for 6 weeks 20 mg ITI-007 ITI-007 20 mg ITI-007 administered orally as formulated capsules once daily for 6 weeks
- Primary Outcome Measures
Name Time Method Positive and Negative Syndrome Scale Total Score 6 weeks
- Secondary Outcome Measures
Name Time Method Positive and Negative Syndrome Scale Subscales 6 weeks
Trial Locations
- Locations (1)
Clinical Site
🇺🇸Long Beach, California, United States