Ignite Creation Date:
2024-05-05 @ 12:05 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00236379
Status:
COMPLETED
Last Update Posted:
2011-05-17
First Post:
2005-10-07
Brief Title:
A Study of the Effects of Risperidone and Olanzapine on Blood Glucose Sugar in Patients With Schizophrenia or Schizoaffective Disorder
Sponsor:
Janssen LP
Organization:
Janssen LP
Study Overview
Official Title:
A Six-month Double-blind Randomized International Multicenter Trial to Evaluate the Glucoregulatory Effects of Risperidone and Olanzapine in Subjects With Schizophrenia or Schizoaffective Disorder
Status:
COMPLETED
Status Verified Date:
2011-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to assess and compare how risperidone and olanzapine two antipsychotic medications affect the regulation of glucose sugar in the body
Detailed Description:
The newer antipsychotic medications risperidone and olanzapine effectively treat schizophrenia and related disorders and they may cause fewer side effects than the older antipsychotic drugs do However some of the newer antipsychotic medications could have a negative effect on the regulation of blood glucose sugar in the body This negative effect could make the patient gain weight and even develop diabetes mellitus This randomized double-blind study will assess and compare how risperidone and olanzapine affect the regulation of glucose in the body in patients with schizophrenia and schizoaffective disorder Patients will be randomly assigned to receive risperidone target oral dose of 6 milligrams per day or olanzapine target oral dose of 20 milligrams per day for 6 months Repeat laboratory measurements will be performed and questions will be asked of the patients to evaluate the safety and effectiveness of the drugs The primary laboratory test used to assess the patients regulation of blood glucose will be the Disposition Index derived from the Frequently Sampled Intravenous Glucose Tolerance Test Risperidone 2 milligram oven-encapsulated tablets taken orally once a day for 6 months olanzapine 5 milligram tablets taken orally once a day for 6 months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None