The New Strategy for Pharmacological Treatment in People With Schizophrenia - Full Text View

Sponsored by:	Inje University
Information provided by:	Inje University
ClinicalTrials.gov Identifier:	NCT00352339

Purpose

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.

Condition	Intervention	Phase
Schizophrenia	Drug: Rispridoen and Aripiprazole Drug: Risperidne Drug: Abilify	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Switch Risperidone to Aripiprazole in Early Stage of Pharmacotherapy of Schizophrenia

Resource links provided by NLM:

MedlinePlus related topics: Schizophrenia

Drug Information available for: Risperidone Aripiprazole

U.S. FDA Resources

Further study details as provided by Inje University:

Primary Outcome Measures:

SANS(Scale for the Assessment of Negative Symptoms) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

SARS(Simpson-Angus Rating Scale) [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
Drug Attitude Inventory [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Side effect checklist [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	90
Study Start Date:	August 2006
Estimated Study Completion Date:	December 2010
Estimated Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Aripiprazole: Experimental switching group (from risperidone to aripiprazole)	Drug: Rispridoen and Aripiprazole Start with risperidone and switch it to aripiprazole. Flexible dose
Risperidone: Active Comparator 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
Abilify: Active Comparator Start with aripiprazole and keep it through the end of study	Drug: Abilify Start with abilify and keep it through the end of study

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.

Eligibility

Ages Eligible for Study:	18 Years to 45 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Schizophrenia, DSM-IV
Acute phase

Exclusion Criteria:

Refractory Schizophrenia
Substance Abuse
High risk for suicide

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00352339

Contacts

Contact: Eun-A Lee, MS

82-51-890-8955

euna066@nate.com

Locations

Korea, Republic of
Dongseo Hospital	Recruiting
Masan, Korea, Republic of, 630-856
Contact: Do-Un Jung, MD 82-016-579-2985 cgabriel@chol.com
Principal Investigator: Do-Un Jung, MD
Dongrae Hospital	Recruiting
Busan, Korea, Republic of, 609-370
Contact: Yung-Soo Seo, MD.PhD 82-51-508-0011 npsys@hanmail.net
Principal Investigator: Young-Soo Seo, MD.PhD

Sponsors and Collaborators

Inje University

Investigators

Principal Investigator:

Joo-Cheol Shim, MD,PhD

Clinical Trial Center, Paik hospital

More Information

Additional Information:

home page of clinical trial center of paik hospital, Inje University This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Clinical Trial Center ( Busan Paik Hospital, Inje University )
Study ID Numbers:	Aripiprazole study 2006
Study First Received:	July 13, 2006
Last Updated:	August 3, 2009
ClinicalTrials.gov Identifier:	NCT00352339 History of Changes
Health Authority:	South Korea: Korea Food and Drug Administration (KFDA)

Keywords provided by Inje University:

Schizophrenia
Switching
Early stage
Risperidone
Aripirazole

Study placed in the following topic categories:

Neurotransmitter Agents
Tranquilizing Agents
Risperidone
Psychotropic Drugs
Central Nervous System Depressants
Antipsychotic Agents
Serotonin

Schizophrenia
Dopamine
Mental Disorders
Psychotic Disorders
Dopamine Agents
Aripiprazole
Schizophrenia and Disorders with Psychotic Features

Additional relevant MeSH terms:

Neurotransmitter Agents
Tranquilizing Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Psychotropic Drugs
Risperidone
Central Nervous System Depressants
Dopamine Antagonists
Antipsychotic Agents
Pharmacologic Actions

Schizophrenia
Serotonin Antagonists
Serotonin Agents
Mental Disorders
Therapeutic Uses
Dopamine Agents
Aripiprazole
Central Nervous System Agents
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on September 03, 2009