Effect on Metabolic Parameters of Abilify in SPR

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2009 by Seoul National Hospital.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Korea Otsuka Pharmaceutical Co.,Ltd.
Information provided by:
Seoul National Hospital
ClinicalTrials.gov Identifier:
NCT00569764
First received: December 6, 2007
Last updated: June 9, 2009
Last verified: June 2009
  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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • prolactin ECG [ Time Frame: 1 year ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Jong-il Lee, Seoul National Hospital
ClinicalTrials.gov Identifier: NCT00569764     History of Changes
Other Study ID Numbers: snh002, MSABLI
Study First Received: December 6, 2007
Last Updated: June 9, 2009
Health Authority: Korea: Food and Drug Administration

Keywords provided by Seoul National Hospital:
schizophrenia
metabolic syndrome
aripiprazole

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

ClinicalTrials.gov processed this record on August 21, 2014