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The New Strategy for Pharmacological Treatment in People With Schizophrenia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00352339
Recruitment Status : Unknown
Verified August 2009 by Inje University.
Recruitment status was:  Recruiting
First Posted : July 14, 2006
Last Update Posted : August 6, 2009
Sponsor:
Information provided by:
Inje University

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.

Condition or disease Intervention/treatment Phase
Schizophrenia Drug: Rispridoen and Aripiprazole Drug: Risperidne Drug: Abilify Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Switch Risperidone to Aripiprazole in Early Stage of Pharmacotherapy of Schizophrenia
Study Start Date : August 2006
Estimated Primary Completion Date : December 2010
Estimated Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

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 Name: abilify is a generic name of aripiprazole




Primary Outcome Measures :
  1. SANS(Scale for the Assessment of Negative Symptoms) [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. SARS(Simpson-Angus Rating Scale) [ Time Frame: 12 weeks ]
  2. Drug Attitude Inventory [ Time Frame: 12 weeks ]
  3. Side effect checklist [ Time Frame: 12 weeks ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Schizophrenia, DSM-IV
  • Acute phase

Exclusion Criteria:

  • Refractory Schizophrenia
  • Substance Abuse
  • High risk for suicide

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00352339


Contacts
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Contact: Eun-A Lee, MS 82-51-890-8955 euna066@nate.com

Locations
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Korea, Republic of
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         
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         
Sponsors and Collaborators
Inje University
Investigators
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Principal Investigator: Joo-Cheol Shim, MD,PhD Clinical Trial Center, Paik hospital

Additional Information:
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Responsible Party: Busan Paik Hospital, Inje University, Clinical Trial Center
ClinicalTrials.gov Identifier: NCT00352339    
Other Study ID Numbers: Aripiprazole study 2006
First Posted: July 14, 2006    Key Record Dates
Last Update Posted: August 6, 2009
Last Verified: August 2009
Keywords provided by Inje University:
Schizophrenia
Switching
Early stage
Risperidone
Aripirazole
Additional relevant MeSH terms:
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Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Risperidone
Aripiprazole
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents
Antidepressive Agents
Dopamine Agonists
Serotonin 5-HT1 Receptor Agonists
Serotonin Receptor Agonists
Serotonin 5-HT2 Receptor Antagonists
Dopamine D2 Receptor Antagonists