Schizophrenia
Conditions
Keywords
Schizophrenia
Brief summary
The purpose of this exploratory study is to evaluate the effects of sertindole and olanzapine on metabolic parameters and syndrome in patients with schizophrenia.
Detailed description
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.
Interventions
DRUGSertindole
12 to 20 mg daily after initial up-titration, encapsulated tablets, orally, 84 days
DRUGOlanzapine
10 to 20 mg daily after initial up-titration, encapsulated tablets, orally, 84 days
Sponsors
H. Lundbeck A/S
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Patients with schizophrenia * Participation in 11286 study * Capable of completing all study-related activities for the duration of the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes from baseline by treatment and between treatments for each of the components of the metabolic syndrome | 12 weeks |
Countries
China
Outcome results
None listed