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NCT01280396 Clinical Trial

Metabolic Side-effects for Second-generation Antipsychotics

Mental Disorders Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01280396
Other study ID # HKCTR-1205
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 2010
Est. completion date December 2014

Study information
Verified date April 2018
Source The University of Hong Kong
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 241
Est. completion date December 2014
Est. primary completion date December 2012
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Locations
Country Name City State
Hong Kong Western Psychiatric Centre Hong Kong

Sponsors (2)
Lead Sponsor Collaborator
The University of Hong Kong Queen Mary Hospital, Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome
Type Measure Description Time frame Safety issue
Primary development of metabolic syndrome according to IDF criteria post treatment with second generation antipsychotics 1 year
Secondary change in BMI post treatment with second generation antipsychotics 1 year
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