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Trial record 1 of 1 for:    NCT00216528
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A Study to Evaluate Symptomatic Remission in Schizophrenia With Long Acting Risperidone Microspheres

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ClinicalTrials.gov Identifier: NCT00216528
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : April 27, 2010
Sponsor:
Information provided by:
Janssen Korea, Ltd., Korea

Brief Summary:
The purpose of this study is to evaluate symptomatic remission rate in patients with schizophrenia using long acting risperidone microspheres

Condition or disease Intervention/treatment Phase
Schizophrenia Drug: risperidone Phase 4

Detailed Description:

Although most of Korean schizophrenic patients currently take oral antipsychotic medications, it is estimated that up to 75% of them have difficulty adhering to daily oral regimen. Long-acting injectable formulation may eliminate this need for daily medication. This is a prospective, open-label, multicenter study to determine the long-term efficacy, especially symptomatic remission rate of long-acting risperidone microspheres administrered in the muscle at 2 week intervals in patients with schizophrenia.

The patients will receive intramuscular injections either 25, 37.5, 50 mg equivalent of risperidone at every 2 weeks for 1 year

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 527 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective, Open-Label Study to Evaluate Symptomatic Remission in Schizophrenia With Long Acting Risperidone Microspheres (Risperdal Consta)
Study Start Date : July 2005
Actual Study Completion Date : April 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia
Drug Information available for: Risperidone




Primary Outcome Measures :
  1. The symptomatic remission rate at 48 weeks

Secondary Outcome Measures :
  1. The change from baseline in Clinical Global Impression-Severity (CGI-S) score at 48 weeks; The change from baseline in SQLS score at 48 weeks; Health-Economic Data


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects with schizophrenia or schizoaffective disorder - Subjects who have experienced relapse or re-admission previously - Subject and/or his/her relative, guardian or legal representative who has signed the informed consent form

Exclusion Criteria:

  • First antipsychotic treatment ever - On clozapine during the last 3 months - Serious unstable medical condition, including recent and present clinically relevant laboratory abnormalities - Subjects that are previously on concomitant use of Risperdal Consta within 60 days prior to entry - Previous sensitivity history to risperidone - History or current symptoms of tardive dyskinesia - History of neuroleptic malignant syndrome - Pregnant or breast-feeding female - Female patient of childbearing age without adequate contraception (adequate contraception includes: abstinence, oral contraceptive, intrauterine devices, barrier method (diaphragm or condom) plus spermicide - Norplant TM or Depo-Provera TM. A female patient of childbearing potential must have an adequate contraception and a negative urine pregnancy test at every visit)

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): NCT00216528


Sponsors and Collaborators
Janssen Korea, Ltd., Korea
Investigators
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Study Director: Janssen Korea, Ltd. Clinical Trial Janssen Korea, Ltd., Korea

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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ClinicalTrials.gov Identifier: NCT00216528    
Other Study ID Numbers: CR004966
First Posted: September 22, 2005    Key Record Dates
Last Update Posted: April 27, 2010
Last Verified: April 2010
Keywords provided by Janssen Korea, Ltd., Korea:
Schizophrenia
risperidone
Intramuscular injection, long-acting risperidone
Additional relevant MeSH terms:
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Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Risperidone
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