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Completed

NCT Number: NCT00759460

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.

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Key information

Conditions

Schizophrenia Mental Disorders Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

CN002

Beijing, 100083, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Treatment and study plan

Sertindole

Drug

12 to 20 mg daily after initial up-titration, encapsulated tablets, orally, 84 days

Olanzapine

Drug

10 to 20 mg daily after initial up-titration, encapsulated tablets, orally, 84 days

Other names: Zyprexa

Primary outcomes

  1. Changes from baseline by treatment and between treatments for each of the components of the metabolic syndrome

    Time frame: 12 weeks

Sponsors and collaborators

Lead sponsor

H. Lundbeck A/S

Industry

Registry information

Official study 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

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Sep 25, 2008
Registry last updated
Sep 20, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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