Metabolic Syndrome in Patients With First-episode Schizophrenia

Schizophrenia Clinical Trial

Official title:

The Metabolic Syndrome in Patients With First-episode Schizophrenia - Prognosis and Prediction.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00957294
• Other study ID #: Lene Nyboe Jacobsen
• Status: Completed
• Phase: N/A
• First received: August 3, 2009
• Last updated: December 2, 2014
• Start date: August 2009
• Est. completion date: April 2013

Study information

• Verified date: March 2012
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Regional Committee on Biomedical Research Ethics
• Study type: Observational

Clinical Trial Summary

The metabolic syndrome (MetS) is highly prevalent in patients with schizophrenia and is a major risk factor of type-2 diabetes, cardiovascular disease and early death. Genetic factors, antipsychotic medication, sleeping disturbances and unhealthy lifestyle are possible causes of developing metabolic syndrome. Several studies have investigated the metabolic side-effects of antipsychotic medication. However it is still unanswered how unhealthy lifestyle, comprising physical inactivity, smoking, unhealthy dieting, and sleeping disturbances adds to the metabolic risk of patients with schizophrenia. The aim of this study is to investigate the prevalence and development of MetS in first-episode patients with schizophrenia and 1 year after onset of treatment. The study's main hypothesis is that physical inactivity, regardless of medication, is an independent risk factor for metabolic syndrome in patients with schizophrenia. In comparison inpatients with major depression and healthy controls, both matched on gender, age and level of education will be included in the study. It is anticipated that the study's results will provide new knowledge about the risk of developing metabolic syndrome in first-episode schizophrenia and how different risk factors contribute to this.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 203
• Est. completion date: April 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• Patients with ICD-10 diagnosed schizophrenia

Exclusion Criteria:

• Antipsychotic medication > 6 weeks before inclusion

• Physical disability

• Pregnancy

• IQ< 55

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Metabolic Syndrome X
• Schizophrenia
• Syndrome

Locations

Country	Name	City	State
Denmark	Research Unit, Dep. Q of Affective Disorders, Aarhus University Hospital, Risskov	Aarhus	Risskov

Sponsors (1)

Lead Sponsor	Collaborator
Aarhus University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	metabolic syndrome		1 year	Yes