Study of a Novel Antipsychotic ITI-007 in Schizophrenia

Study Overview
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Brief Summary
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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.

Detailed Description
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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 safety of two dose levels of ITI-007 administered daily for 28 days will be evaluated as compared to placebo; risperidone has been included as a positive control. Upon completion of the inpatient 28-day Study Treatment Period, patients will be started on standard antipsychotic medication and will be stabilized over a 5-day period before discharge from the study clinic. Patients will be seen for a final outpatient safety evaluation at the End-of-Study visit approximately 2 weeks after discharge.

Official Title
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A Randomized, Double-blind, Placebo-controlled, Multi-center Study to Assess the Antipsychotic Efficacy of ITI-007 in Patients With Schizophrenia

Conditions
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Schizophrenia

Intervention / Treatment
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* Drug: ITI-007
* Drug: Placebo
* Drug: Risperidone


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ITI-007 Low Dose<br> | Drug: ITI-007<br>* Capsules containing ITI-007 for 28 days<br>Drug: Placebo<br>* Capsules containing inactive placebo for 28 days<br>|
| Experimental: ITI-007 High Dose<br> | Drug: ITI-007<br>* Capsules containing ITI-007 for 28 days<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Capsules containing inactive placebo for 28 days<br>|
| Active Comparator: Risperidone<br> | Drug: Risperidone<br>* Capsules containing risperidone for 28 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Positive and Negative Syndrome Scale (PANSS) total score |  | Change from baseline to Day 28 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Positive and Negative Syndrome Scale (PANSS) total score |  | Change from baseline to Day 8, 15, 22 |