Metabolic Effects of Switching to Aripiprazole in Patient... | NCT00845988

Studies
Metabolic Effects of Switching to Aripiprazole in Patients With Bipolar Disorders

NCT00845988

Sponsor

Seoul National University Hospital

Status

Completed

Last Update Posted

Dec 5, 2013Estimated

Enrollment

28Actual

Phase

Phase 4

Conditions

Bipolar Disorders
Metabolic Complication

Interventions

aripiprazole

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

Status Module

Record Verification Date

Dec 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2008

Primary Completion Date

Mar 2012Actual

Completion Date

Mar 2012Actual

First Submitted Date

Feb 14, 2009

First Submission Date that Met QC Criteria

Feb 14, 2009

First Posted Date

Feb 18, 2009Estimated

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

Dec 4, 2013

Last Update Posted Date

Dec 5, 2013Estimated

Name	Class
Korea Otsuka Pharmaceutical Co., Ltd.	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

The primary goal of this study is to investigate metabolic changes and maintaining efficacy in stabilized patients with bipolar disorders who have pharmacologically induced weight gain.

Detailed Description

reduced treatment adherence due to metabolic side effects
suggested advantages of aripiprazole in metabolic profile over other antipsychotics or mood stabilizers
randomized trial of switch from previous drugs to aripiprazole

Design Module

Study Type

Interventional

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

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

28Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
treatment as usual	Active Comparator	patients showing weight gain while receiving treatment with risperidone, olanzapine, quetiapine, or clozapine	Drug: aripiprazole
switch to aripiprazole	Experimental	aripiprazole	Drug: aripiprazole

Interventions

Name	Type	Description	Arm Group Labels	Other Names
aripiprazole	Drug	dosage form : po recommended dosage : more than 10mg/day duration : 28 weeks	switch to aripiprazole treatment as usual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Weight BMI Glucose and lipid profiles CGI-BP KOQOL SWN-K		0, 4, 8, 12, 18, 26 week

Secondary Outcomes

Measure	Description	Time Frame
ECG prolactin SAS BAS UKU-SERS-Pat-Korean version		0, 4, 8, 12, 18, 26 week

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients with bipolar disorders (I, II, NOS) diagnosed with DSM-IV criteria
age between 18 and 65
Decisional capacity is adequate to provide informed consent or has an authorized appropriate surrogate decision maker. in a syndromal remission state at least for 2 months : CGI - BP ≤ 3
patients who have exhibited a clinically significant increase in body weight after starting the administration of their current antipsychotic (ie >7% weight gain)

Exclusion Criteria:

diagnosis of eating disorder, substance abuse, and psychotic disorder
history of neurological and medical illness
pregnant or breast feeding women

Accepts Healthy Volunteers

Yes

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

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Kyooseob Ha, MD, PhD	Seoul National University Bundang Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Seoul National University Bundang Hospital		Seongnam-si	Gyeonggi-do	463-707	South Korea

Condition Browse Module

MeSH Terms

ID	Term
D001714	Bipolar Disorder
D015430	Weight Gain
D024821	Metabolic Syndrome

Ancestor Terms

ID	Term
D000068105	Bipolar and Related Disorders
D019964	Mood Disorders
D001523	Mental Disorders
D001836	Body Weight Changes

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000068180	Aripiprazole

Ancestor Terms

ID	Term
D010879	Piperazines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D015363	Quinolones

Browse Leaves

Not provided

Browse Branches

Not provided