Phase 3
Completed N=459
A 6 Month Study to Compare the Metabolic Effects of Paliperidone ER and Olanzapine in Patients With Schizophrenia
Source: ClinicalTrials.gov NCT00645099 ↗Enrolled (actual)
459
Serious AEs
7.2%
Results posted
Jul 2010
Primary outcomePrimary: Change From Baseline to End Point in the Triglycerides (TG) to High Density Lipoprotein (HDL) Ratio (TG:HDL Ratio) — -0.08; 0.42 Ratio — p=< 0.0001
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline to End Point in the Triglycerides (TG) to High Density Lipoprotein (HDL) Ratio (TG:HDL Ratio) |
-0.08; 0.42 | < 0.0001 sig |
| SECONDARY Change From Baseline to End Point in Triglycerides |
-0.01; 0.36 | <0.0001 sig |
| SECONDARY Change From Baseline to End Point in High Density Lipoprotein |
0.01; -0.04 | 0.0050 sig |
| SECONDARY Change From Baseline to End Point in Total Cholesterol |
0.0263; 0.2886 | <0.0001 sig |
| SECONDARY Change From Baseline to End Point in Low Density Lipoprotein Cholesterol (Friedwald QT) |
-0.0029; 0.1892 | 0.0004 sig |
| SECONDARY Change From Baseline to End Point in Converted Insulin |
2.7397; 17.2327 | 0.0272 sig |
| SECONDARY Change From Baseline to End Point in Fasting Glucose |
-0.2071; 0.0769 | 0.1892 |
| SECONDARY Change From Baseline to End Point in Homeostatic Model Assessment of Beta-cell Function (HOMA-%B) |
-7.54; 18.82 | 0.0325 sig |
| SECONDARY Change From Baseline to End Point in Homeastatic Model Assessment of Insulin Resistance (HOMA-IR) |
0.28; 0.43 | 0.1117 |
| SECONDARY Number of Patients Meeting the Criteria for Type 2 Diabetes Mellitus During Follow-up |
21; 23 | 0.6346 |
| SECONDARY Number of Patients With Onset of Impaired Glucose Tolerance |
36; 33 | 1.0000 |
| SECONDARY Number of Patients With Impaired Fasting Glucose |
68; 66 | 0.6770 |
| SECONDARY Change From Baseline at End Point of the Insulinogenic Index |
2.21; 33.78 | 0.1308 |
| SECONDARY Change From Baseline at End Point of Mari-Type Analysis of Glucose Sensitivity for Insulin |
8.63; 17.28 | 0.3358 |
| SECONDARY Change From Baseline at End Point in Body Weight |
1.16; 3.81 | <0.0001 sig |
| SECONDARY Change From Baseline at End Point in Body Mass Index (BMI) |
0.43; 1.32 | <0.0001 sig |
| SECONDARY Change From Baseline at End Point in Waist Circumference |
0.70; 3.38 | <0.0001 sig |
| SECONDARY Number of Patients First Meeting the NCEP/ATP III Criteria for Metabolic Syndrome During Follow-up |
23; 38 | 0.0230 sig |
| SECONDARY Change From Baseline to End Point in Total Positive and Negative Syndrome Scale Score (PANSS) |
-13.50; -16.60 | 0.0242 sig |
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 ( 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
Data sourced from ClinicalTrials.gov (NCT00645099). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.