A 6 Month Study to Compare the Metabolic Effects of Paliperidone ER and Olanzapine in Patients With Schizophrenia

• Status: Completed
• Trial end date: 2009-04-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this 6 month study is to compare the metabolic effects of paliperidone ER and olanzapine in patients with schizophrenia, using the ratio of the concentration of lipids (triglycerides (TG)) in the blood to the concentration of good cholesterol (high density lipoproteins (HDL)) in the blood as the primary parameter. Approximately 456 adult patients will participate in this study.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Janssen-Cilag International NV
• Treatments: Olanzapine; Paliperidone Palmitate

Criteria

Inclusion Criteria:

• Patient meets the DSM-IV criteria for schizophrenia

• Patient has a PANSS total score at screening of 60 to 100, inclusive

• Patient must, in the opinion of the investigator, benefit from treatment with paliperidone ER or olanzapine

• Patients on lipid-lowering therapy must be on a stable dose for at least 4 weeks for statins, niacin, ezetimibe and resins or for at least 12 weeks for fibrates

• Female patients must be postmenopausal (for at least 1 year), surgically sterile, abstinent, or, if sexually active, be practicing and effective method of birth control (e.g. prescription oral contraceptives, contraceptive injections, intrauterine device, double-barrier method, contraceptive patch, male partner sterilization) before entry and throughout the study

• Women of child-bearing potential must have a negative urine pregnancy test at screening

• Patient is healthy on the basis of a physical examination and vital signs at screening

Exclusion Criteria:

• Patient has previously been treated with paliperidone ER, olanzapine, or clozapine within the past 6 months or has never been treated with an antipsychotic before

• Treatment with a depot antipsychotic within the past 3 months

• Treatment with a mood stabilizer or a recently initiated antidepressant (<= 3 months)

• Patient has abnormal fasting plasma glucose (> 126 mg/dL) or fasting triglycerides (TG) levels (> 400 mg/dL) at screening

• Relevant history of any significant and/or unstable cardiovascular, respiratory, neurologic (including seizures or significant cerebrovascular), renal, hepatic, endocrine, or immunologic diseases, including recent or present clinically relevant laboratory abnormalities (as deemed by the investigator)

• History or current symptoms of tardive dyskinesia

• History of neuroleptic malignant syndrome

• Pregnant or breast-feeding female