The purpose of this study is to determine the safety and efficacy of iloperidone compared to placebo and an active comparator in the treatment of patients with schizophrenia in acute exacerbation.
Schizophrenia is a severe mental illness affecting an estimated 1% of the world's population. Patients with schizophrenia suffer from productive symptoms (e.g., hallucinations and delusions), and deficit symptoms (e.g., a reduction or absence of normal behaviors or emotions). Other symptoms include a reduced ability to recall and learn new information. Iloperidone is being development as a treatment for symptoms of schizophrenia. This trial will test the safety and efficacy of iloperidone in patients with an acute exacerbation of the disease.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
593
Change From Baseline in Positive and Negative Symptom Scale Total (PANSS-T) Score
The PANSS is a 30-item scale developed to assess the severity of symptoms of schizophrenia. The PANSS items are divided into positive, negative, and general psychopathology factors. Items are rated on a scale of 1 (absent) to 7 (extremely severe). The PANSS-T score is the sum of scores for all 30 PANSS items (i.e., the sum of the three subscales), with a minimum score of 30 and a maximum score of 210. Higher scores indicate more severe symptoms. A negative change from baseline indicates improvement.
Time frame: 4 weeks
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