Status:
COMPLETED
Study of a Novel Antipsychotic ITI-007 in Schizophrenia
Lead Sponsor:
Intra-Cellular Therapies, Inc.
Conditions:
Schizophrenia
Eligibility:
All Genders
18-55 years
Phase:
PHASE2
Brief 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...
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 safe...
Eligibility Criteria
Inclusion
- Patient's age is 18-55
- Patient has current diagnosis of schizophrenia and is experiencing an acute exacerbation of psychosis
- Patient has a history of at least three months exposure to one or more antipsychotic therapy(ies) and a prior response to antipsychotic therapy within the previous five years
Exclusion
- Any female patient who is pregnant or breast-feeding
- Any patient presenting with concurrent dementia, delirium, mental retardation, epilepsy, drug-induced psychosis, or history of significant brain trauma
- Any patient presenting with schizoaffective disorder, bipolar disorder, acute mania, or major depression with psychotic features
- Any patient considered to be an imminent danger to themselves or others
- Any patient with hematological, renal, hepatic, endocrinological, neurological, or cardiovascular disease or substance abuse as defined by protocol
- Any patient judged by the Investigator to be inappropriate for the study
Key Trial Info
Start Date :
December 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2013
Estimated Enrollment :
335 Patients enrolled
Trial Details
Trial ID
NCT01499563
Start Date
December 1 2011
End Date
November 1 2013
Last Update
October 3 2025
Active Locations (8)
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1
Clinical Site
Little Rock, Arkansas, United States
2
Clinical Site
Garden Grove, California, United States
3
Clinical Site
Atlanta, Georgia, United States
4
Clinical Site
Rockville, Maryland, United States