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NCT00352339 Clinical Trial

The New Strategy for Pharmacological Treatment in People With Schizophrenia

Schizophrenia Clinical Trial

Official title:
Switch Risperidone to Aripiprazole in Early Stage of Pharmacotherapy of Schizophrenia

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT00352339
Other study ID # Aripiprazole study 2006
Secondary ID
Status Recruiting
Phase Phase 4
First received July 13, 2006
Last updated August 3, 2009
Start date August 2006
Est. completion date December 2010

Study information
Verified date August 2009
Source Inje University
Contact Eun-A Lee, MS
Phone 82-51-890-8955
Email euna066@nate.com
Is FDA regulated No
Health authority South Korea: Korea Food and Drug Administration (KFDA)
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 90
Est. completion date December 2010
Est. primary completion date December 2010
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 45 Years
Eligibility Inclusion Criteria:

- Schizophrenia, DSM-IV

- Acute phase

Exclusion Criteria:

- Refractory Schizophrenia

- Substance Abuse

- High risk for suicide

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Rispridoen and Aripiprazole
Start with risperidone and switch it to aripiprazole. Flexible dose
• Risperidne
Start with risperidne and keep it through the end of study. Risperidne:flexible dose
• Abilify
Start with abilify and keep it through the end of study

Locations
Country Name City State
Korea, Republic of Dongrae Hospital Busan
Korea, Republic of Dongseo Hospital Masan

Sponsors (1)
Lead Sponsor Collaborator
Inje University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary SANS(Scale for the Assessment of Negative Symptoms) 12 weeks No
Secondary SARS(Simpson-Angus Rating Scale) 12 weeks Yes
Secondary Drug Attitude Inventory 12 weeks No
Secondary Side effect checklist 12 weeks Yes
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