Study of a Novel Antipsychotic ITI-007 in Schizophrenia

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

335 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-12-31

Study Completion Date

2013-11-30

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.

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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.

Conditions

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Schizophrenia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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ITI-007 Low Dose

Lumateperone 42 mg (ITI-007 60 mg tosylate) administered for 28 days

Group Type EXPERIMENTAL

ITI-007

Intervention Type DRUG

Capsules containing ITI-007 for 28 days

Placebo

Intervention Type DRUG

Capsules containing inactive placebo for 28 days

ITI-007 High Dose

Lumateperone 84 mg (ITI-007 120 mg tosylate) administered for 28 days

Group Type EXPERIMENTAL

ITI-007

Intervention Type DRUG

Capsules containing ITI-007 for 28 days

Placebo

Placebo: Capsules containing inactive placebo administered for 28 days

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Capsules containing inactive placebo for 28 days

Risperidone

Risperidone: Capsules containing 4 mg risperidone administered for 28 days

Group Type ACTIVE_COMPARATOR

Risperidone

Intervention Type DRUG

Capsules containing risperidone for 28 days

Interventions

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ITI-007

Capsules containing ITI-007 for 28 days

Intervention Type DRUG

Placebo

Capsules containing inactive placebo for 28 days

Intervention Type DRUG

Risperidone

Capsules containing risperidone for 28 days

Intervention Type DRUG

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No