EICHORCondition: Schizophrenia · Sponsor: Intra-Cellular Therapies, Inc.
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.
This description comes directly from the study's public registry record.
No contact information is available for this study as per the public registry record.
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Inclusion Criteria: * 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 Criteria: * 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
Reproduced word-for-word from the public registry record — the study team can answer questions about it.
| Clinical Site | Little Rock, Arkansas, United States | — |
| Clinical Site | Garden Grove, California, United States | — |
| Clinical Site | Atlanta, Georgia, United States | — |
| Clinical Site | Rockville, Maryland, United States | — |
| Clinical Site | St Louis, Missouri, United States | — |
| Clinical Site | Willingboro, New Jersey, United States | — |
| Clinical Site | Philadelphia, Pennsylvania, United States | — |
| Clinical Site | Austin, Texas, United States | — |
This study lists sites in the areas below. Each link shows other recruiting studies near that city, from the public registry record.
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Source record: clinicaltrials.gov/study/NCT01499563