A 6 Month Study to Compare the Metabolic Effects of Paliperidone ER and Olanzapine in Patients With Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 3

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.
    

Detailed description: 
      This is a prospective randomized (study medication is assigned by change) open-label,
      parallel-group, multicenter, 6 month study to compare the metabolic effects of paliperidone
      ER and olanzapine in patients with schizophrenia using the ratio of the concentration of
      lipids (triglycerides) in the blood to the concentration of good cholesterol (high density
      lipoproteins (HDL)) as the primary parameter. Secondary objectives include evaluation of
      additional parameters related to the total of the actions of the body to keep it alive
      (metabolic endpoints) and demonstration of non-inferiority of paliperidone ER versus
      olanzapine in efficacy as measured by Positive and Negative Syndrome Scale (PANSS). Patients
      previously treated with any oral antipsychotic, except those treated with paliperidone ER,
      olanzapine or clozapine during the last 6 months, can be enrolled and will be treated with
      paliperidone ER (6 to 9 mg/day) or olanzapine (10 to 15 mg/day). Patients will be divided
      into groups according to the metabolic effects of their previous antipsychotic medication
      (medication that does not increase body weight vs. medication that increases body weight).
      Throughout the study flexible dosing is allowed based on the investigator discretion. A study
      treatment period of 6 months is planned for all patients. Medication to treat symptoms like
      confusion, blurred vision, constipation, dry mouth, light-headedness, difficulty starting and
      continuing to urinate, and loss of bladder control may continue up to four weeks and should
      then be tapered off at the discretion of the investigator. Approximately 456 adult patients
      (228 in each treatment group) will participate in this study. Efficacy will be assessed with
      the following measures: PANSS (total score and subscale scores), Clinical Global Impression -
      Severity (CGI-S), Self-rated health status Survey SF-36, and Sleep and daytime drowsiness
      evaluation scale. The parameters related to the total of the actions of the body to keep it
      alive (metabolic endpoints) will be assessed with the following: ratio of blood lipids to
      blood good cholesterol concentrations (TG:HDL ratio) (for this primary evaluation, plasma
      fasting lipids and good cholesterol concentrations will be measured), fasting plasma insulin
      and fasting plasma glucose, plasma glucose and insulin concentrations before and after a 75
      gram oral glucose tolerance test (OGTT) to asses insulin sensitivity and changes in insulin
      secretion, fasting good cholesterol, lipids, and glucose levels for the determination of new
      onset or presence of metabolic syndrome during treatment according to criteria of the Third
      Report of the National Cholesterol Education Program Expert Panel on Detection, Evaluation,
      and Treatment of High Blood Cholesterol in Adults (NCEP/ATPIII criteria), weight,
      Body-Mass-Index and waist circumference for the determination of new onset or presence of a
      medical condition associated with abdominal obesity, abnormalities in glucose, lipid and
      cholesterol metabolism, and elevated blood pressure that increases the risk of cardiovascular
      disease and type 2 diabetes (metabolic syndrome) during treatment according to NCEP/ATP III
      criteria. All patients who receive trial medication (paliperidone ER or olanzapine) at least
      once will be included in the analysis of the demographic and baseline characteristic data. 2
      dosage levels of paliperidone ER (6 or 9mg per day) and 2 of olanzapine (10 and 15mg per day)
      are available to the patients. Throughout the study flexible dosing is allowed based on the
      investigator's discretion. Study medication is to be taken in the morning orally, with water.
      A study treatment period of 6 months is planned for all patients.
    

Intervention name(s): olanzapine; paliperidone ER
Intervention type(s): Drug; Drug
Intervention description(s): 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
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Paliperidone ER; Olanzapine; Schizophrenia