NCT00569764

Brief Summary

To measure the long-term changes in weight and plasma lipids after switching antipsychotic treatment to aripiprazole

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
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2007

Geographic Reach
1 country

2 active sites

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

December 1, 2007

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

December 6, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 7, 2007

Completed
1.8 years 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

First QC Date

December 6, 2007

Last Update Submit

June 9, 2009

Conditions

SchizophreniaMetabolic Syndrome

Keywords

schizophreniametabolic syndromearipiprazole

Outcome Measures

Primary Outcomes (1)

  • weight lipid profile : HDL, LDL, total-cholesterol, triglyceride fasting blood glucose

    1 year

Secondary Outcomes (1)

  • prolactin ECG

    1 year

Study Arms (1)

observational

patients with schizophrenia who want to change an antipsychotics due to metabolic side effect

Eligibility Criteria

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

patients with schizophrenia who want to change an antipsychotics due to metabolic side effects

You may qualify if:

  • DSM-IV diagnosis with schizophrenia
  • who signed an informed consent

You may not qualify if:

  • comorbid with substance abuse or substance dependence
  • pregnancy or lactation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Seoul National Hospital

Seoul, 039-757, South Korea

RECRUITING

Seoul National Hospital

Seoul, 139-757, South Korea

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood sampling

MeSH Terms

Conditions

SchizophreniaMetabolic Syndrome

Condition Hierarchy (Ancestors)

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

Study Officials

  • Jong-il Lee, M.D.

    Seoul National Hospital

    STUDY DIRECTOR

Central Study Contacts

Shi Hyun Kang, MD

CONTACT

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

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

December 6, 2007

First Posted

December 7, 2007

Study Start

December 1, 2007

Study Completion

October 1, 2009

Last Updated

June 12, 2009

Record last verified: 2009-06

Locations

KR(2)