The New Strategy for Pharmacological Treatment in People With Schizophrenia

NCT ID: NCT00352339

Last Updated: 2009-08-06

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

Clinical Phase

PHASE4

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-08-31

Study Completion Date

2010-12-31

Brief Summary

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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

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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.

Conditions

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Schizophrenia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Aripiprazole

switching group (from risperidone to aripiprazole)

Group Type EXPERIMENTAL

Rispridoen and Aripiprazole

Intervention Type DRUG

Start with risperidone and switch it to aripiprazole. Flexible dose

Risperidone

Start with risperidone and keep it through the end of study

Group Type ACTIVE_COMPARATOR

Risperidne

Intervention Type DRUG

Start with risperidne and keep it through the end of study. Risperidne:flexible dose

Abilify

Start with aripiprazole and keep it through the end of study

Group Type ACTIVE_COMPARATOR

Abilify

Intervention Type DRUG

Start with abilify and keep it through the end of study

Interventions

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Risperidne

Start with risperidne and keep it through the end of study. Risperidne:flexible dose

Intervention Type DRUG

Abilify

Start with abilify and keep it through the end of study

Intervention Type DRUG

Rispridoen and Aripiprazole

Start with risperidone and switch it to aripiprazole. Flexible dose

Intervention Type DRUG

Other Intervention Names

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abilify is a generic name of aripiprazole

Eligibility Criteria

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Inclusion Criteria

* Schizophrenia, DSM-IV
* Acute phase

Exclusion Criteria

* Refractory Schizophrenia
* Substance Abuse
* High risk for suicide
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Inje University

OTHER

Sponsor Role lead

Responsible Party

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Clinical Trial Center

Principal Investigators

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Joo-Cheol Shim, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Clinical Trial Center, Paik hospital

Locations

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Dongrae Hospital

Busan, , South Korea

Site Status RECRUITING

Dongseo Hospital

Masan, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Eun-A Lee, MS

Role: CONTACT

82-51-890-8955

Facility Contacts

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Yung-Soo Seo, MD.PhD

Role: primary

82-51-508-0011

Do-Un Jung, MD

Role: primary

82-016-579-2985

Other Identifiers

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Aripiprazole study 2006

Identifier Type: -

Identifier Source: org_study_id

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