NCT00759460

Study on Metabolic Parameters of Sertindole in Patients With Schizophrenia

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 250 (actual)
• Sponsor: H. Lundbeck A/S · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Schizophrenia

Interventions

Type	Name	Description
DRUG	Sertindole	12 to 20 mg daily after initial up-titration, encapsulated tablets, orally, 84 days
DRUG	Olanzapine	10 to 20 mg daily after initial up-titration, encapsulated tablets, orally, 84 days

Timeline

• Start date: 2007-03-01
• Primary completion: 2008-03-01
• Completion: 2008-04-01
• First posted: 2008-09-25
• Last updated: 2013-09-20

Locations

1 site across 1 country: China