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Metabolic Side-effects for Second-generation Antipsychotics

Sponsor
The University of Hong Kong (Other)
Overall Status
Completed
CT.gov ID
NCT01280396
Collaborator
Queen Mary Hospital, Hong Kong (Other)
241
Enrollment
1
Location
49
Duration (Months)
4.9
Patients Per Site Per Month

Study Details

Study Description

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 Intervention/Treatment Phase

    Study Design

    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 :
    Nov 1, 2010
    Actual Primary Completion Date :
    Dec 1, 2012
    Actual Study Completion Date :
    Dec 1, 2014

    Arms and Interventions

    Arm Intervention/Treatment
    SGAs

    patients receiving SGAs

    Outcome Measures

    Primary Outcome Measures

    1. development of metabolic syndrome according to IDF criteria [1 year]

      post treatment with second generation antipsychotics

    Secondary Outcome Measures

    1. change in BMI [1 year]

      post treatment with second generation antipsychotics

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Western Psychiatric Centre Hong Kong Hong Kong 00000

    Sponsors and Collaborators

    • The University of Hong Kong
    • Queen Mary Hospital, Hong Kong

    Investigators

    • Principal Investigator: Albert Kar Kin Chung, MBBS, Department of Psychiatry, Queen Mary Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Dr. Albert Kar-Kin Chung, Clinical Assistant Professor, The University of Hong Kong
    ClinicalTrials.gov Identifier:
    NCT01280396
    Other Study ID Numbers:
    • HKCTR-1205
    First Posted:
    Jan 20, 2011
    Last Update Posted:
    May 3, 2018
    Last Verified:
    Apr 1, 2018
    Keywords provided by Dr. Albert Kar-Kin Chung, Clinical Assistant Professor, The University of Hong Kong
    metabolic
    SGAs
    clozapine
    Additional relevant MeSH terms:
    Mental Disorders

    Study Results

    No Results Posted as of May 3, 2018