Effect on Metabolic Parameters of Abilify in SPR | NCT00569764

Studies
Effect on Metabolic Parameters of Abilify in SPR

NCT00569764

Sponsor

Seoul National Hospital

Status

Unknown status

Last Update Posted

Jun 12, 2009Estimated

Enrollment

100Estimated

Phase

Not provided

Conditions

Schizophrenia
Metabolic Syndrome

Interventions

Not provided

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
MSABLI

Status Module

Record Verification Date

Jun 2009

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2007

Primary Completion Date

Not provided

Completion Date

Oct 2009Estimated

First Submitted Date

Dec 6, 2007

First Submission Date that Met QC Criteria

Dec 6, 2007

First Posted Date

Dec 7, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 9, 2009

Last Update Posted Date

Jun 12, 2009Estimated

Name	Class
Korea Otsuka Pharmaceutical Co., Ltd.	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
observational		patients with schizophrenia who want to change an antipsychotics due to metabolic side effect

Interventions

Not provided

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
prolactin ECG		1 year

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Shi Hyun Kang, MD	Contact	82-2-2204-0326		drshe@hanmail.net

Overall Officials

Name	Affiliation	Role
Jong-il Lee, M.D.	Seoul National Hospital	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Seoul National Hospital	Recruiting	Seoul		039-757	South Korea

Condition Browse Module

MeSH Terms

ID	Term
D012559	Schizophrenia
D024821	Metabolic Syndrome

Ancestor Terms

ID	Term
D019967	Schizophrenia Spectrum and Other Psychotic Disorders
D001523	Mental Disorders
D007333	Insulin Resistance
D006946	Hyperinsulinism

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Browse Branches

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