Study on Metabolic Parameters of Sertindole in Patients With Schizophrenia
The purpose of this exploratory study is to evaluate the effects of sertindole and olanzapine on metabolic parameters and syndrome in patients with schizophrenia.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||An Exploratory Study Conducted as an Add-on to Clinical Trial 11286, to Evaluate the Metabolic Effect of up to 12 Weeks Treatment With Sertindole and Olanzapine in Patients With Schizophrenia|
- Changes from baseline by treatment and between treatments for each of the components of the metabolic syndrome [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
|Study Start Date:||March 2007|
|Study Completion Date:||April 2008|
|Primary Completion Date:||March 2008 (Final data collection date for primary outcome measure)|
12 to 20 mg daily after initial up-titration, encapsulated tablets, orally, 84 days
|Active Comparator: 2||
10 to 20 mg daily after initial up-titration, encapsulated tablets, orally, 84 days
Other Name: Zyprexa
The prevalence of metabolic syndrome is estimated to be around 20-25% of the population and is particularly high in patients with schizophrenia. Individuals with metabolic syndrome are twice as likely to die from, and three times as likely to suffer from a heart attack or stroke compared to individuals without the syndrome.
Patients on atypical antipsychotic medication should be considered a high risk group for diabetes and cardiovascular disease. Weight gain is common in patients taking neuroleptics and atypical antipsychotics, and excessive body weight is a risk factor for type 2 diabetes.