Effect on Metabolic Parameters of Abilify in SPR

June 9, 2009 updated by: Seoul National Hospital

The Effects of Metabolic Parameters of Aripiprazole in Patients With Schizophrenia

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

Study Overview

Status

Unknown

Conditions

Detailed 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.

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 139-757
        • Recruiting
        • Seoul National Hospital
        • Contact:
      • Seoul, Korea, Republic of, 039-757
        • Recruiting
        • Seoul National Hospital
        • Contact:
        • Principal Investigator:
          • Jong il Lee, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
observational
patients with schizophrenia who want to change an antipsychotics due to metabolic side effect

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
weight lipid profile : HDL, LDL, total-cholesterol, triglyceride fasting blood glucose
Time Frame: 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
prolactin ECG
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National Hospital

Collaborators

Korea Otsuka Pharmaceutical Co., Ltd.

Investigators

  • Study Director: Jong-il Lee, M.D., Seoul National Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2007

Study Completion (Anticipated)

October 1, 2009

Study Registration Dates

First Submitted

December 6, 2007

First Submitted That Met QC Criteria

December 6, 2007

First Posted (Estimate)

December 7, 2007

Study Record Updates

Last Update Posted (Estimate)

June 12, 2009

Last Update Submitted That Met QC Criteria

June 9, 2009

Last Verified

June 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • snh002
  • MSABLI

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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