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Metabolic Side-effects for Second-generation Antipsychotics

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01280396
Recruitment Status : Completed
First Posted : January 20, 2011
Last Update Posted : May 3, 2018
Queen Mary Hospital, Hong Kong
Information provided by (Responsible Party):
Dr. Albert Kar-Kin Chung, 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.

Condition or disease
Mental Disorders

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Study Type : Observational
Actual Enrollment : 241 participants
Observational Model: Other
Time Perspective: Retrospective
Official Title: Metabolic Side-effects in Patients Receiving Clozapine and Second-generation Antipsychotics in an Outpatient Clinic
Study Start Date : November 2010
Actual Primary Completion Date : December 2012
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mental Disorders

patients receiving SGAs

Primary Outcome Measures :
  1. development of metabolic syndrome according to IDF criteria [ Time Frame: 1 year ]
    post treatment with second generation antipsychotics

Secondary Outcome Measures :
  1. change in BMI [ Time Frame: 1 year ]
    post treatment with second generation antipsychotics

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Out-patients in a public psychiatric out-patient centre

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01280396

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Hong Kong
Western Psychiatric Centre
Hong Kong, Hong Kong, 00000
Sponsors and Collaborators
The University of Hong Kong
Queen Mary Hospital, Hong Kong
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Principal Investigator: Albert Kar Kin Chung, MBBS Department of Psychiatry, Queen Mary Hospital
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Responsible Party: Dr. Albert Kar-Kin Chung, Clinical Assistant Professor, The University of Hong Kong Identifier: NCT01280396    
Other Study ID Numbers: HKCTR-1205
First Posted: January 20, 2011    Key Record Dates
Last Update Posted: May 3, 2018
Last Verified: April 2018
Keywords provided by Dr. Albert Kar-Kin Chung, The University of Hong Kong:
Additional relevant MeSH terms:
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Mental Disorders