| Eligibility |
Inclusion Criteria:
- Subjects meet ICD10 criteria for a primary diagnosis of schizophrenia;
- Subjects have a score = 4 on the CGI-S at Screening and Baseline;
- Subjects have a PANSS total score = 70 and = 120 at Screening and Baseline, with a
score 4 (moderate) or higher in 2 or more items on the following PANSS items:
delusions, conceptual disorganization, hallucinations, unusual thought content and
suspiciousness;
- Subjects with acute (including recurrence /relapse and first episode) phase patients
with schizophrenia;
- Ability to understand the contents of interview and provide written informed consent
(If subject is unable to sign, subject's legal guardian or impartial witness shall
sign the informed consent).
Exclusion Criteria:
- Subjects with severe or unstable physical diseases (including but not limited to
severe or unstable cardiovascular diseases, cerebrovascular diseases, liver and kidney
diseases) determined by the investigators;
- Subjects had a history of stomach or intestinal surgery or any other condition that
could interfere with absorption, distribution, metabolism, or excretion of
medications;
- Based on the judgement of investigators, subject has a history of refractory psychosis
and/or subject has been treated with clozapine (for any reason) within 4 months of
baseline;
- Subjects has used long-term antipsychotic drugs, e.g. Haloperidol decanoate injection,
Fluphenazine decanoate injection, Risperidone microspheres injection, Paliperidone
palmitate injection, Paliperidone palmitate injection (3M), in the following time
prior to the enrolment;
- Subjects is at risk of suicide or self-mutilation behaviours or the act of endangering
others, or other corresponding characteristic behaviour, or a history of suicide;
- Female subjects were pregnant (positive pregnancy test at screening) or breast-feeding
or planning pregnancy for the duration of the study, or the partners of male subjects
were planning pregnancy for the duration of the study;
- Need to use of disallowed concomitant therapy which is specified in the protocol;
- History of severe allergy or hypersensitivity;
- Currently has severe liver function impairment, or serum alanine aminotransferase
(ALT) or aspartate aminotransferase (AST) level =3 times the upper limit of normal
value;
- Creatinine clearance rate < 50mL/min Creatinine clearance rate*100%= Male: (140 - Age)
x Weight(kg)/Serum creatinine (mg/dL) x 72 Female: 0.85*(140 - Age) x Weight(kg)/Serum
creatinine (mg/dL) x 72
- A history of malignant tumors (including benign pituitary tumors);
- Any chronic organic disease of the central nervous system (excluding schizophrenia),
such as CNS related tumors and inflammation, active seizures, vascular disease,
Parkinson's disease, Alzheimer's disease, or other forms of dementia, myasthenia
gravis, and other degenerative diseases. A history of mental retardation or persistent
neurological symptoms caused by severe head injury;
- Subjects received electroconvulsive therapy (ECT) within 90 days prior to screening,
or were expected to require ECT during the study;
- A history of neuroleptic malignant syndrome;
- Severe tardive dyskinesia, severe dystonia, or any other severe dyskinesia;
- Angioedema occurred after previous administration of lurasidone;
- The subject is participating in or has participated in other clinical trials,
including the use of commercially available drugs or medical devices, within 30 days
prior to the signing of the informed consent;
- Patients who had previously participated in a clinical study of lurasidone;
- Any other conditions judged by the investigators that not suitable to participate in
this study.
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