Metabolic Side-effects for Second-generation Antipsychotics

NCT01280396 | Completed

• 1 other identifier: HKCTR-1205
• Study Type: observational
• Target: 241
• Locations: 1 country
• Sites: 1

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.

Conditions

Mental Disorders

Keywords

metabolic; SGAs; clozapine

Outcome Measures

Primary Outcomes (1)

• development of metabolic syndrome according to IDF criteria

  post treatment with second generation antipsychotics

  1 year

Secondary Outcomes (1)

• change in BMI

  1 year

Study Arms (1)

SGAs

patients receiving SGAs

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Out-patients in a public psychiatric out-patient centre

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• The University of Hong Kong: lead
• Queen Mary Hospital, Hong Kong: collaborator

Study Sites (1)

Western Psychiatric Centre

Hong Kong, 00000, Hong Kong

Location

MeSH Terms

Conditions

Mental Disorders

Study Officials

• Albert Kar Kin Chung, MBBS

  Department of Psychiatry, Queen Mary Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Study Record Dates

• First Submitted: January 19, 2011
• First Posted: January 20, 2011
• Study Start: November 1, 2010
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2014
• Last Updated: May 3, 2018

Record last verified: 2018-04

Locations

HK (1)