The New Strategy for Pharmacological Treatment in People With Schizophrenia

August 3, 2009 updated by: Inje University

Switch Risperidone to Aripiprazole in Early Stage of Pharmacotherapy of Schizophrenia

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

90

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Busan, Korea, Republic of, 609-370
        • Recruiting
        • Dongrae Hospital
        • Contact:
        • Principal Investigator:
          • Young-Soo Seo, MD.PhD
      • Masan, Korea, Republic of, 630-856
        • Recruiting
        • Dongseo hospital
        • Contact:
        • Principal Investigator:
          • Do-Un Jung, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Schizophrenia, DSM-IV
  • Acute phase

Exclusion Criteria:

  • Refractory Schizophrenia
  • Substance Abuse
  • High risk for suicide

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Aripiprazole
switching group (from risperidone to aripiprazole)
Drug: Rispridoen and Aripiprazole
Start with risperidone and switch it to aripiprazole. Flexible dose
Active Comparator: Risperidone
Start with risperidone and keep it through the end of study
Drug: Risperidne
Start with risperidne and keep it through the end of study. Risperidne:flexible dose
Active Comparator: Abilify
Start with aripiprazole and keep it through the end of study
Drug: Abilify
Start with abilify and keep it through the end of study
Other Names:
  • abilify is a generic name of aripiprazole

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Inje University

Investigators

  • Principal Investigator: Joo-Cheol Shim, MD,PhD, Clinical Trial Center, Paik hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2006

Primary Completion (Anticipated)

December 1, 2010

Study Completion (Anticipated)

December 1, 2010

Study Registration Dates

First Submitted

July 13, 2006

First Submitted That Met QC Criteria

July 13, 2006

First Posted (Estimate)

July 14, 2006

Study Record Updates

Last Update Posted (Estimate)

August 6, 2009

Last Update Submitted That Met QC Criteria

August 3, 2009

Last Verified

August 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Aripiprazole study 2006

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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