Effect on Metabolic Parameters of Abilify in SPR

NCT ID: NCT00569764

Last Updated: 2009-06-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-12-31

Study Completion Date

2009-10-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Schizophrenia Metabolic Syndrome

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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observational

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

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* comorbid with substance abuse or substance dependence
* pregnancy or lactation
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Korea Otsuka Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role collaborator

Seoul National Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Seoul National Hospital

Principal Investigators

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Jong-il Lee, M.D.

Role: STUDY_DIRECTOR

Seoul National Hospital

Locations

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Seoul National Hospital

Seoul, , South Korea

Site Status RECRUITING

Seoul National Hospital

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Shi Hyun Kang, MD

Role: CONTACT

82-2-2204-0326

Facility Contacts

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Shi Hyun Kang, M.D.

Role: primary

82-2-2204-0326

Jong-il Lee, M.D., Ph.D.

Role: primary

82-2-2204-0104

Other Identifiers

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MSABLI

Identifier Type: -

Identifier Source: secondary_id

snh002

Identifier Type: -

Identifier Source: org_study_id

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