Study of a Novel Antipsychotic ITI-007 in Schizophrenia

Phase 2

Completed

• Conditions: Schizophrenia
• Interventions: Drug: ITI-007; Drug: Risperidone; Drug: Placebo

• Registration Number: NCT01499563
• Lead Sponsor: Intra-Cellular Therapies, Inc.

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 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

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.

Study Timeline

• Study Start: 2011-12
• Study First Submitted: 2011-12-16
• Study First Submitted QC: 2011-12-22
• Study First Posted: 2011-12-26
• Primary Completion: 2013-08
• Study Completion: 2013-11
• Status Verified: 2014-09
• Disposition First Submitted: 2014-09-03
• Disposition First Submitted QC: 2014-09-03
• Disposition First Posted: 2014-09-10
• Last Update Submitted: 2017-03-09
• Last Update Posted: 2017-03-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 335

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ITI-007 Low Dose	Placebo	-
ITI-007 High Dose	ITI-007	-
Placebo	Placebo	-
Risperidone	Risperidone	-
ITI-007 Low Dose	ITI-007	-

Primary Outcome Measures

Name	Time	Method
Positive and Negative Syndrome Scale (PANSS) total score	Change from baseline to Day 28

Secondary Outcome Measures

Name	Time	Method
Positive and Negative Syndrome Scale (PANSS) total score	Change from baseline to Day 8, 15, 22