Effectiveness and Safety of 3 Fixed Doses (25 mg eq., 100 mg eq., and 150 mg eq.) of Paliperidone Palmitate in Patients With Schizophrenia

Inclusion Criteria

• Met diagnostic criteria for schizophrenia according to Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM IV) for at least 1 year before screening. Prior medical records, written documentation or verbal information obtained from previous psychiatric providers obtained by the investigator must be consistent with the diagnosis of schizophrenia
• A total PANSS score at screening of between 70 and 120, inclusive and at baseline of between 60 and 120, inclusive
• Body mass index (BMI)
• i.e., [weight (kg)]/[height (m)]², of >17.0 kg/m2
• Women must be postmenopausal for at least 2 years, surgically sterile, abstinent, or agree to practice an effective method of birth control if they are sexually active before entry and throughout the study. Effective methods of birth control include: prescription hormonal contraceptives, intrauterine device, double-barrier method, and male partner sterilization. Women of childbearing potential must have a negative urine pregnancy test at baseline, before receiving a dose of study drug
• Is able and willing to meet or perform study requirements (e.g., answer self-administered questionnaires). If a patient is unable to read the questions, study personnel may read documents and the patient may then mark his or her choice
• Patients in the US must be able to understand spoken English to permit adequate ratings by the blinded central rater

Exclusion Criteria

• Primary diagnosis other than schizophrenia
• Patients who are unable to provide their own consent or who are currently involuntarily committed to psychiatric hospitalization
• DSM-IV diagnosis of active substance dependence within 3 months before the screening evaluation (nicotine and caffeine dependence are not exclusionary)
• History of treatment resistance as defined by failure to respond to 2 adequate studies of different antipsychotic medications
• an adequate study is defined as a minimum of 4 weeks at the patient's maximum tolerated dose
• Relevant history of or current presence of any significant or unstable cardiovascular, respiratory, neurological (including seizures or significant cerebrovascular), renal, hepatic, hematologic, endocrine, immunologic, morbid obesity (BMI>=40), or other systemic disease
• History of any severe preexisting gastrointestinal narrowing (pathologic or iatrogenic) or inability to swallow the oral tolerability medication whole with the aid of water for patients requiring oral tolerability testing
• Biochemistry, hematology or urinalysis test results that are not within the laboratory's normal reference range and are deemed to be clinically significant by the investigator
• History or evidence of clinically significant hepatic disease (including aspartate aminotransferase [AST] or alanine aminotransferase [ALT] >2 times the upper limit of normal) at screening
• History of neuroleptic malignant syndrome
• Significant risk of suicidal, homicidal or violent ideation or behavior as clinically assessed by the investigator
• History of life threatening allergic reaction to any drug
• Known or suspected hypersensitivity or intolerance of risperidone, paliperidone, Intralipid (placebo) or any of their excipients (e.g., soybean oil, egg yolks, phospholipids, glycerol)
• Exposure to an experimental drug, experimental biologic, or experimental medical device within 6 months before screening or prior randomization into this study
• Enrollment in 2 or more clinical research studies in the previous year or one or more clinical research studies in the previous 6 months (non intervention, observational, and retrospective studies excluded)
• History of any active malignancy within the previous 5 years, with the exception of excised basal cell carcinomas
• A woman who is pregnant, breast-feeding, or planning to become pregnant during the study period
• Employee of the investigator or study center, with direct involvement in the proposed study or other studies under the direction of