Study on Metabolic Parameters of Sertindole in Patients With Schizophrenia

Phase 3

Completed

• Conditions: Schizophrenia
• Interventions: Drug: Olanzapine; Drug: Sertindole

• Registration Number: NCT00759460
• Lead Sponsor: H. Lundbeck A/S

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.

Study Timeline

• Study Start: 2007-03
• Primary Completion: 2008-03
• Study Completion: 2008-04
• Study First Submitted: 2008-09-24
• Study First Submitted QC: 2008-09-24
• Study First Posted: 2008-09-25
• Status Verified: 2013-09
• Last Update Submitted: 2013-09-19
• Last Update Posted: 2013-09-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 250

Inclusion Criteria

• Patients with schizophrenia
• Participation in 11286 study
• Capable of completing all study-related activities for the duration of the study

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Olanzapine	-
1	Sertindole	-

Primary Outcome Measures

Name	Time	Method
Changes from baseline by treatment and between treatments for each of the components of the metabolic syndrome	12 weeks

Trial Locations

Locations (1)

CN002; 🇨🇳 Beijing, China