Study of a Novel Antipsychotic ITI-007 in Schizophrenia

Completed · Phase 2 · Has a placebo group

Conditions studied: Schizophrenia

In brief

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.

Key facts

Study ID

NCT01499563

Run by

Intra-Cellular Therapies, Inc.

People needed

335

Starts

2011-12-01

Expected to finish

2013-11-01

Last updated by the study team

2025-10-03

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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