NCT01499563 - Study of a Novel Antipsychotic ITI-007 in Schizophrenia | Crick

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

335

Conditions

Schizophrenia

Interventions

ITI-007DRUG

Capsules containing ITI-007 for 28 days

PlaceboDRUG

Capsules containing inactive placebo for 28 days

RisperidoneDRUG

Capsules containing risperidone for 28 days

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 Years

Medical Language ↔ Plain English

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

Locations (8)

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

Outcomes

Primary Outcomes

Change From Baseline to Day 28 in Positive and Negative Syndrome Scale (PANSS) Total Score

The PANSS is a 30-item scale used to measure symptoms of schizophrenia. The scale has 7 positive symptom items, 7 negative symptom items, and 16 general psychopathology symptom items. Each item is scored on a 7-point scale by the clinical rater based on a clinical interview with the patient, with a score of 1 indicating the absence of symptoms and a score of 7 indicating extremely severe symptoms. Thus, the PANSS Total score minimum is 30 and the maximum is 210, with higher numbers indicating more severe symptoms.

Time frame: Change from baseline to Day 28

Secondary Outcomes

Change From Baseline to Day 8 in Positive and Negative Syndrome Scale (PANSS) Total Score

The PANSS is a 30-item scale used to measure symptoms of schizophrenia. The scale has 7 positive symptom items, 7 negative symptom items, and 16 general psychopathology symptom items. Each item is scored on a 7-point scale by the clinical rater based on a clinical interview with the patient, with a score of 1 indicating the absence of symptoms and a score of 7 indicating extremely severe symptoms. Thus, the PANSS Total score minimum is 30 and the maximum is 210, with higher numbers indicating more severe symptoms.

Time frame: Change from Baseline to Day 8

Change From Baseline to Day 15 in Positive and Negative Syndrome Scale (PANSS) Total Score

The PANSS is a 30-item scale used to measure symptoms of schizophrenia. The scale has 7 positive symptom items, 7 negative symptom items, and 16 general psychopathology symptom items. Each item is scored on a 7-point scale by the clinical rater based on a clinical interview with the patient, with a score of 1 indicating the absence of symptoms and a score of 7 indicating extremely severe symptoms. Thus, the PANSS Total score minimum is 30 and the maximum is 210, with higher numbers indicating more severe symptoms.

Time frame: Change from Baseline to Day 15

Change From Baseline to Day 22 in Positive and Negative Syndrome Scale (PANSS) Total Score