Metabolic Side-effects for Second-generation Antipsychotics

Metabolic Side-effects in Patients Receiving Clozapine and Second-generation Antipsychotics in an Outpatient Clinic

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01280396

Enrollment

241

Registered

2011-01-20

Start date

2010-11-30

Completion date

2014-12-31

Last updated

2018-05-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mental Disorders

Keywords

metabolic, SGAs, clozapine

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.

Interventions

None listed

Study design

Observational model

OTHER

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
development of metabolic syndrome according to IDF criteria	1 year	post treatment with second generation antipsychotics

Secondary

Measure	Time frame	Description
change in BMI	1 year	post treatment with second generation antipsychotics

Countries

Hong Kong

Outcome results