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Effect on Metabolic Parameters of Abilify in SPR

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2009 by Seoul National Hospital.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00569764
First Posted: December 7, 2007
Last Update Posted: June 12, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Korea Otsuka Pharmaceutical Co., Ltd.
Information provided by:
Seoul National Hospital
  Purpose
To measure the long-term changes in weight and plasma lipids after switching antipsychotic treatment to aripiprazole

Condition
Schizophrenia Metabolic Syndrome

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: The Effects of Metabolic Parameters of Aripiprazole in Patients With Schizophrenia

Resource links provided by NLM:


Further study details as provided by Seoul National Hospital:

Primary Outcome Measures:
  • weight lipid profile : HDL, LDL, total-cholesterol, triglyceride fasting blood glucose [ Time Frame: 1 year ]

Secondary Outcome Measures:
  • prolactin ECG [ Time Frame: 1 year ]

Biospecimen Retention:   Samples Without DNA
blood sampling

Estimated Enrollment: 100
Study Start Date: December 2007
Estimated Study Completion Date: October 2009
Groups/Cohorts
observational
patients with schizophrenia who want to change an antipsychotics due to metabolic side effect

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
patients with schizophrenia who want to change an antipsychotics due to metabolic side effects
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • comorbid with substance abuse or substance dependence
  • pregnancy or lactation
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00569764


Contacts
Contact: Shi Hyun Kang, MD 82-2-2204-0326 drshe@hanmail.net

Locations
Korea, Republic of
Seoul National Hospital Recruiting
Seoul, Korea, Republic of, 039-757
Contact: Shi Hyun Kang, M.D.    82-2-2204-0326    drshe@hanmail.net   
Principal Investigator: Jong il Lee, M.D.         
Seoul National Hospital Recruiting
Seoul, Korea, Republic of, 139-757
Contact: Jong-il Lee, M.D., Ph.D.    82-2-2204-0104    lji7542@hanmail.net   
Sponsors and Collaborators
Seoul National Hospital
Korea Otsuka Pharmaceutical Co., Ltd.
Investigators
Study Director: Jong-il Lee, M.D. Seoul National Hospital
  More Information

Responsible Party: Jong-il Lee, Seoul National Hospital
ClinicalTrials.gov Identifier: NCT00569764     History of Changes
Other Study ID Numbers: snh002
MSABLI
First Submitted: December 6, 2007
First Posted: December 7, 2007
Last Update Posted: June 12, 2009
Last Verified: June 2009

Keywords provided by Seoul National Hospital:
schizophrenia
metabolic syndrome
aripiprazole

Additional relevant MeSH terms:
Schizophrenia
Metabolic Syndrome X
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Aripiprazole
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs