Table 1.
Patient inclusion and exclusion criteria
|
Criteria | |
| Patients satisfying all of the following requirements are eligible. | |
| • |
Outpatients aged 20 years or over at the time of consent acquisition |
| • |
Patients with schizophrenia satisfying the DSM-IV-TR diagnostic criteria |
| • |
Patients requiring antipsychotic treatment or switching from the current antipsychotic medication to others because of lack of efficacy, intolerability, or other reasons |
| • |
Patients capable of issuing consent to participate in the study in writing |
|
Exclusion criteria | |
| Patients falling under any of the following criteria are excluded from this study. | |
| • |
Patients having a history of allergy to any component of the test drugs or risperidone |
| • |
Patients under strong influence from drugs that suppress the central nervous system, such as barbiturate derivatives |
| • |
Patients receiving adrenaline |
| • |
Patients receiving azole antifungal agents (excluding topical preparations) or HIV protease inhibitors |
| • |
Patients with moderately or severely compromised renal function (creatinine clearance less than 50 mL/min at the time of eligibility assessment) |
| • |
Patients with poorly controlled diabetes mellitus (HbA1c (NGSP) over 8.4% at the time of eligibility assessment) |
| • |
Patients presenting with severe symptoms despite sufficient antipsychotic treatment or patients having a history of clozapine therapy |
| • |
Patients having other psychiatric disease in addition to schizophrenia |
| • |
Patients with complication of Parkinson’s disease |
| • |
Patients presenting with malignant syndrome or similar symptoms or patients with water poisoning |
| • |
Patients having signs of physical exhaustion, such as dehydration and malnutrition |
| • |
Patients having malignant tumor requiring treatment |
| • |
Patients with a history of alcohol or drug abuse |
| • |
Pregnant or possibly pregnant women, lactating women, or women desiring to become pregnant during the study period |
| • |
Patients likely to attempt suicide (CGI-SS class 4 or higher (severe tendency for suicide)) |
| • | Other patients judged by the physician in charge as inappropriate for the study |
DSM-IV-TR, Diagnostic and Statistical Manual of Mental Disorders, 4th edition, text revision; HIV, human immunodeficiency virus; HbA1c, glycohemoglobin A1c; NGSP, National Glycohemoglobin Standardization Program; CGI-SS, Clinical Global Impression-Suicide Scale.