A 6 Month Study to Compare the Metabolic Effects of Paliperidone ER and Olanzapine in Patients With Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Intervention: olanzapine; paliperidone ER
Intervention description: 10-15 mg (using 5-mg or 10-mg tablets) once daily flexible dosing for 6 months; 6-mg or 9-mg tablet once daily flexible dosing for 6 months
Intervention MeSH terms: Olanzapine; Paliperidone Palmitate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 462.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Paliperidone ER; Olanzapine; Schizophrenia

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.
    

Eligibility 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