Metabolic Side-effects for Second-generation Antipsychotics

Completed

• Conditions: Mental Disorders

• Registration Number: NCT01280396
• Lead Sponsor: The University of Hong Kong

Brief Summary

Second-generation antipsychotics (SGAs), including clozapine, are commonly used nowadays as treatment for psychosis. There are increasing concerns about their related metabolic side-effects over weight gain, risks to cause glucose intolerance and hyperlipidemia, and a specific condition known as metabolic syndrome. All these side-effects might be associated with the increased risk of cardiovascular diseases and diabetes mellitus.

This study is to analyze the simple physical measurements (weight and height) and venous blood tests (for fasting blood glucose and lipid) results collected routinely since 2008 (recommended by the local hospital authority as a territory-wide "SGAs Monitoring Program") from those outpatients receiving SGAs (amisulpride, aripiprazole, olanzapine, paliperidone, quetiapine, risperidone and ziprasidone) and/or clozapine, at a local psychiatric outpatient clinic in Hong Kong. The investigators hypothesized that there should be differential risks on metabolic side-effects amongst these SGAs.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-11
• Study First Submitted: 2011-01-19
• Study First Submitted QC: 2011-01-19
• Study First Posted: 2011-01-20
• Primary Completion: 2012-12
• Study Completion: 2014-12
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-30
• Last Update Posted: 2018-05-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 241

Inclusion Criteria

• was ≥18 years of age
• out-patients
• had received any one of these antipsychotics: aripiprazole, amisulpride, clozapine, olanzapine, paliperidone, quetiapine, risperidone, ziprasidone
• consented to provide physical measurements and venous blood samples

Exclusion Criteria

• not consented to provide venous blood samples and/or physical measurement

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
development of metabolic syndrome according to IDF criteria	1 year	post treatment with second generation antipsychotics

Secondary Outcome Measures

Name	Time	Method
change in BMI	1 year	post treatment with second generation antipsychotics

Trial Locations

Locations (1)

Western Psychiatric Centre; 🇭🇰 Hong Kong, Hong Kong