NCT02093858

Brief Summary

Almost all of antipsychotics can induce metabolic syndrome,Genetic factors play a key role in the development of metabolic syndrome,TCF7L2 and SLC30A8 are strongestly correlated with metabolic syndrome.Moreover,Antipsychotics have an effect on the expression of TCF7L2 and SLC30A8 genes.It indicates the variations of TCF7L2 and SLC30A8 play an important part in the development of antipsychotics-induced metabolic syndrome.

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
212

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2014

Typical duration for all trials

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

First Submitted

Initial submission to the registry

March 20, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 21, 2014

Completed
11 days until next milestone

Study Start

First participant enrolled

April 1, 2014

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

March 21, 2014

Status Verified

March 1, 2014

Enrollment Period

3.7 years

First QC Date

March 20, 2014

Last Update Submit

March 20, 2014

Conditions

SchizophreniaMetabolic Syndrome

Keywords

Metabolic Syndrome

Outcome Measures

Primary Outcomes (1)

  • Change in weight and blood glucose

    24 weeks

Secondary Outcomes (1)

  • Change of the blood pressure and blood lipid

    24 weeks

Other Outcomes (1)

  • Change of serum insulin

    24 weeks

Study Arms (1)

olanzapine

15-25mg/day for 24 weeks

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

All participants met the Diagnostic and Statistical Manual of Mental Disorder-Fourth Edition (DSM-IV) criteria for first episode schizophrenia.All of the patients and their familier are know of the study and sign the informed consent.

You may qualify if:

  • Clinical diagnosis of first episode schizophrenia
  • Must be able to swallow tablets
  • Take only one antipsychotics

You may not qualify if:

  • liver or renal or cardiovascular diseases
  • pregnant or lactating women
  • drug and alcohol dependence

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mental Health Institute

Changsha, Hunan, 410011, China

Location

MeSH Terms

Conditions

SchizophreniaMetabolic Syndrome

Condition Hierarchy (Ancestors)

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

Study Officials

  • Wu R Rong, PhD

    Central South University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

RenRong Wu, PhD

CONTACT

0731-85554052wurenrong2013@163.com

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

March 20, 2014

First Posted

March 21, 2014

Study Start

April 1, 2014

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

March 21, 2014

Record last verified: 2014-03

Locations

CN(1)