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Effect on Metabolic Parameters of Abilify in SPR

Sponsor
Seoul National Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT00569764
Collaborator
Korea Otsuka Pharmaceutical Co., Ltd. (Industry)
100
Enrollment
2
Locations
22
Duration (Months)
50
Patients Per Site
2.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Anticipated Enrollment :
    100 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    Official Title:
    The Effects of Metabolic Parameters of Aripiprazole in Patients With Schizophrenia
    Study Start Date :
    Dec 1, 2007
    Anticipated Study Completion Date :
    Oct 1, 2009

    Arms and Interventions

    Arm Intervention/Treatment
    observational

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

    Outcome Measures

    Primary Outcome Measures

    1. weight lipid profile : HDL, LDL, total-cholesterol, triglyceride fasting blood glucose [1 year]

    Secondary Outcome Measures

    1. prolactin ECG [1 year]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 Seoul National Hospital Seoul Korea, Republic of 039-757
    2 Seoul National Hospital Seoul Korea, Republic of 139-757

    Sponsors and Collaborators

    • Seoul National Hospital
    • Korea Otsuka Pharmaceutical Co., Ltd.

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00569764
    Other Study ID Numbers:
    • snh002
    • MSABLI
    First Posted:
    Dec 7, 2007
    Last Update Posted:
    Jun 12, 2009
    Last Verified:
    Jun 1, 2009
    Keywords provided by , ,
    schizophrenia
    metabolic syndrome
    aripiprazole
    Additional relevant MeSH terms:
    Metabolic Syndrome
    Schizophrenia

    Study Results

    No Results Posted as of Jun 12, 2009