NCT00717509

Brief Summary

We are going to investigate the association of multiple genetic polymorphisms with the metabolic side effects in patients with schizophrenia taking clozapine.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2007

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2007

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

July 16, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 17, 2008

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2009

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2009

Completed
Last Updated

June 12, 2009

Status Verified

June 1, 2009

Enrollment Period

1.3 years

First QC Date

July 16, 2008

Last Update Submit

June 9, 2009

Conditions

SchizophreniaMetabolic SyndromeGenetic Polymorphism

Keywords

schizophreniametabolic side effectclozapinegenetic polymorphism

Outcome Measures

Primary Outcomes (1)

  • The associations between multiplegenetic polymorphisms (HTR2C,leptin,adrenergic receptor,PPAR,GNB3) and the metabolic side effects (weight,glucose,lipid,BP,metabolic syndrome)

    more than 1 year after starting clozapine

Study Arms (1)

clozapine group

* chronic schizophrenia * have been taking clozapine at leaset one year * without diabetes, pulmonary tuberculosis

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

patients with schizophrenia taking clozapine more than 1 year

You may qualify if:

  • age 18-65
  • who can understand and sign the informed consent

You may not qualify if:

  • who refuse to participate this study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National Hospital

Seoul, 139-757, South Korea

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

peripheral blood

MeSH Terms

Conditions

SchizophreniaMetabolic Syndrome

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental DisordersInsulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Shi Hyun Kang, M.D.

    Seoul National Hospital

    STUDY DIRECTOR

Central Study Contacts

Shi Hyun Kang, M.D.

CONTACT

82-2-2204-0326drshe@hanmail.net

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

July 16, 2008

First Posted

July 17, 2008

Study Start

October 1, 2007

Primary Completion

January 1, 2009

Study Completion

October 1, 2009

Last Updated

June 12, 2009

Record last verified: 2009-06

Locations

KR(1)