ABOUT THIS STUDY
- (1).First-episode or non-refractory recurrent male or female in-hospitalized subjects (aged 18 to 65 years) with a diagnosis of schizophrenia and a minimum score of 70 on the Positive and Negative Syndrome Scale (PANSS) at randomization. First-episode is defined as duration of illness from the onset of psychotic symptoms ranged from 3 days to 36 months and without systemic treatment. Refractory is defined as failure to experience a therapeutic response during acute exacerbation following adequate trials of marketed antipsychotic agents on two or more occasions during the two years prior to study entry.
(2).Patients who meet DSM-IV-TR criteria for schizophrenia and have been diagnosed as having "295.XX schizophrenia".
(3).Patients with a CDSS total score of 5 or more in screening visit and baseline visit.
(4).Patients or their guardian have the ability to understand and to provide informed consent to the examination, observation, and evaluation processes specified in this protocol, and have signed the informed consent from based on a full understanding of the trial.
- (1).Patients who have received systemic treatment of any antipsychotics or
antidepressants within 12 weeks prior to informed consent.
(2).Women who are pregnant, possibly pregnant, or breast-feeding. (3).Patients with
psychotic symptoms that are clearly due to another general medical condition or direct
physiological effects of a substance.
(4).Patients who have met DSM-IV-TR criteria for a substance-related disorder within 3
months (90 days) prior to informed consent (excluding caffeine- and nicotine-related
disorders but including abuse of benzodiazepines) (5).Patients who have received ECT
treatment within 8 weeks prior to informed Consent.
(6).Patients who have used supplements containing centrally-acting substances
(tryptophan, St. John's wort) within 4 weeks prior to informed consent.
(7).Patients with unstable thyroid disorder (hypothyroidism, hyperthyroidism) or those
who have received thyroid treatment within 3 months (90 days) prior to informed
(8).Patients considered to be unresponsive to clozapine (9).Patients at significant
risk of developing a severe adverse event. Patients who have a medical condition that
would interfere with assessments of safety or efficacy during the course of the study,
or who have a history of such a condition. For example, patients diagnosed as having a
complication of serious hepatic, renal, cardiac, or hematopoietic disorder, such as
those described below, within 4 weeks prior to informed consent or during the
screening period Hepatic disorder: Total bilirubin≥3.0 mg/dL, AST (GOT) and
ALT(GPT)≥2.5 times the upper limits of normal levels Renal disorder: Creatinine ≥ 2
mg/dL Cardiac disorder: patients with a known history of QT prolongation (including
congenital long QT syndrome); patients with recent acute myocardial infarction;
patients with uncompensated heart failure (10).Patients known to have a history or
complication of allergy to ziprasidone or other quinolinone-skeleton compounds
(11).Patients with a history or a complication of neuroleptic malignant syndrome
(12).Patients who represent a significant risk of committing suicide (13).Patients
with a history or a complication of organic brain disorder or convulsive disorder,
such as epilepsy
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