Status:
COMPLETED
A 6 Month Study to Compare the Metabolic Effects of Paliperidone ER and Olanzapine in Patients With Schizophrenia
Lead Sponsor:
Janssen-Cilag International NV
Conditions:
Schizophrenia
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief 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 (T...
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 p...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2009
Estimated Enrollment :
462 Patients enrolled
Trial Details
Trial ID
NCT00645099
Start Date
October 1 2007
End Date
April 1 2009
Last Update
May 8 2014
Active Locations (46)
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1
Buenos Aires, Argentina
2
Córdoba, Argentina
3
Mendoza, Argentina
4
Alexandria, Egypt