The New Strategy for Pharmacological Treatment in People... | NCT00352339

Studies
The New Strategy for Pharmacological Treatment in People With Schizophrenia

NCT00352339

Sponsor

Inje University

Status

Unknown status

Last Update Posted

Aug 6, 2009Estimated

Enrollment

90Estimated

Phase

Phase 4

Conditions

Schizophrenia

Interventions

Rispridoen and Aripiprazole
Risperidne
Abilify

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

Aug 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

Aug 2006

Primary Completion Date

Dec 2010Estimated

Completion Date

Dec 2010Estimated

First Submitted Date

Jul 13, 2006

First Submission Date that Met QC Criteria

Jul 13, 2006

First Posted Date

Jul 14, 2006Estimated

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

Aug 3, 2009

Last Update Posted Date

Aug 6, 2009Estimated

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

Switching from Risperidone to Aripiprazole in early stage of pharmacotherapy will demonstrate the same efficacy as compared to risperidone continuation treatment in the treatment of schizophrenia.

Detailed Description

It has been thought that D2 Blocking agent is necessary in acute as well as maintenance phase of pharmacological treatment of patients with schizophrenia. However, this classical strategy produces long term adverse events of drug such as TD, osteoporosis and some metabolic syndrome. To overcome these adverse events, new strategy for pharmacological treatment is needed.

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

90Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Aripiprazole	Experimental	switching group (from risperidone to aripiprazole)	Drug: Rispridoen and Aripiprazole
Risperidone	Active Comparator	Start with risperidone and keep it through the end of study	Drug: Risperidne
Abilify	Active Comparator	Start with aripiprazole and keep it through the end of study	Drug: Abilify

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Rispridoen and Aripiprazole	Drug	Start with risperidone and switch it to aripiprazole. Flexible dose	Aripiprazole

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
SANS(Scale for the Assessment of Negative Symptoms)		12 weeks

Secondary Outcomes

Measure	Description	Time Frame
SARS(Simpson-Angus Rating Scale)		12 weeks
Drug Attitude Inventory		12 weeks
Side effect checklist

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Schizophrenia, DSM-IV
Acute phase

Exclusion Criteria:

Refractory Schizophrenia
Substance Abuse
High risk for suicide

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Eun-A Lee, MS	Contact	82-51-890-8955		euna066@nate.com

Overall Officials

Name	Affiliation	Role
Joo-Cheol Shim, MD,PhD	Clinical Trial Center, Paik hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Dongrae Hospital	Recruiting	Busan		609-370	South Korea

Condition Browse Module

MeSH Terms

ID	Term
D012559	Schizophrenia

Ancestor Terms

ID	Term
D019967	Schizophrenia Spectrum and Other Psychotic Disorders
D001523	Mental Disorders

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