A Trial to Assess the Antipsychotic Efficacy of ITI-007

Intra-Cellular Therapies, Inc.450 enrolled

Overview

The study will be conducted as a randomized, double-blind, parallel-group, placebo-controlled, multi-center study in patients diagnosed with schizophrenia having an acute exacerbation of psychosis.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

450

Conditions

Schizophrenia

Interventions

ITI-007DRUG

PlaceboDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

Inclusion Criteria: * male or female subjects of any race, ages 18-60 inclusive, with a clinical diagnosis of schizophrenia * experiencing an acute exacerbation of psychosis Exclusion Criteria: * any subject unable to provide informed consent * any female subject who is pregnant or breast-feeding * any subject judged to be medically inappropriate for study participation

Locations (11)

Clinical Site

Little Rock, Arkansas, United States

Clinical Site

Springdale, Arkansas, United States

Clinical Site

Escondido, California, United States

Clinical Site

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: 28 days

Secondary Outcomes

Change From Baseline to Day 28 in Clinical Global Impressions-Severity of Illness Scale

The Clinical Global Impressions (CGI) Scale is a standardized assessment tool that the clinician can use to rate the severity of illness, change over time, and efficacy of medication, taking into account the subject's clinical condition and the severity of side effects. The CGI Scale consists of 3 global subscales, only one of which was used in the present study. The first subscale, Severity of Illness (CGI-S), assesses the clinician's impression of the subject's current illness state; it is often used both before and after treatment. Scores on the Severity of Illness subscale range from 1 = "not ill" at all to 7 = "among the most extremely ill."

Time frame: 28 days

Data from ClinicalTrials.gov

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