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NCT00569764 Clinical Trial

Effect on Metabolic Parameters of Abilify in SPR

Schizophrenia Clinical Trial

Official title:
The Effects of Metabolic Parameters of Aripiprazole in Patients With Schizophrenia

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT00569764
Other study ID # snh002
Secondary ID MSABLI
Status Recruiting
Phase N/A
First received December 6, 2007
Last updated June 9, 2009
Start date December 2007
Est. completion date October 2009

Study information
Verified date June 2009
Source Seoul National Hospital
Contact Shi Hyun Kang, MD
Phone 82-2-2204-0326
Email drshe@hanmail.net
Is FDA regulated No
Health authority Korea: Food and Drug Administration
Study type Observational

Clinical Trial Summary

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

Description:

To measure the long-term changes in weight, plasma lipids and fasting blood glucose after switching antipsychotic treatment to aripiprazole, 1 year, open label studies in out and in-patients with schizophrenia.

The measurement of weight and lipid profile and fasting blood glucose will be measured at baseline and every 3 months for 1 year.

Recruitment information / eligibility
Status Recruiting
Enrollment 100
Est. completion date October 2009
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- DSM-IV diagnosis with schizophrenia

- who signed an informed consent

Exclusion Criteria:

- comorbid with substance abuse or substance dependence

- pregnancy or lactation

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
Korea, Republic of Seoul National Hospital Seoul
Korea, Republic of Seoul National Hospital Seoul

Sponsors (2)
Lead Sponsor Collaborator
Seoul National Hospital Korea Otsuka Pharmaceutical Co.,Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary weight lipid profile : HDL, LDL, total-cholesterol, triglyceride fasting blood glucose 1 year No
Secondary prolactin ECG 1 year No
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