The New Strategy for Pharmacological Treatment in People With Schizophrenia

• Sponsor: Inje University (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT00352339
• Collaborator: (none)
• Enrollment: 90
• Locations: 2
• Arms: 3
• Duration (Months): 52
• Patients Per Site: 45
• Patients Per Site Per Month: 0.9

Study Details

Study Description

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.

Study Design

• Study Type: Interventional
• Anticipated 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: Aug 1, 2006
• Anticipated Primary Completion Date: Dec 1, 2010
• Anticipated Study Completion Date: Dec 1, 2010

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. SANS(Scale for the Assessment of Negative Symptoms) [12 weeks]

Secondary Outcome Measures

1. SARS(Simpson-Angus Rating Scale) [12 weeks]

2. Drug Attitude Inventory [12 weeks]

3. Side effect checklist [12 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 45 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Schizophrenia, DSM-IV

• Acute phase

Exclusion Criteria:

• Refractory Schizophrenia

• Substance Abuse

• High risk for suicide

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Dongrae Hospital	Busan		Korea, Republic of	609-370
2	Dongseo Hospital	Masan		Korea, Republic of	630-856

Sponsors and Collaborators

• Inje University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• home page of clinical trial center of paik hospital, Inje University

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00352339
• Other Study ID Numbers: Aripiprazole study 2006
• First Posted: Jul 14, 2006
• Last Update Posted: Aug 6, 2009
• Last Verified: Aug 1, 2009

• Keywords provided by , ,: Schizophrenia; Switching; Early stage; Risperidone; Aripirazole
• Additional relevant MeSH terms: Schizophrenia; Aripiprazole

Study Results

No Results Posted as of Aug 6, 2009