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Evaluation of Efficacy and Safety of Long-acting Risperidone Microspheres in Patients With Schizophrenia or Other Psychotic Disorders When Switching From Typical Antipsychotic (Oral/Depot) or Atypical Oral Other Than Risperidone

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ClinicalTrials.gov Identifier: NCT00563017
Recruitment Status : Unknown
Verified July 2010 by Hospital Authority, Hong Kong.
Recruitment status was:  Recruiting
First Posted : November 26, 2007
Last Update Posted : July 7, 2010
Sponsor:
Collaborator:
Janssen Pharmaceutica N.V., Belgium
Information provided by:
Hospital Authority, Hong Kong

Study Description
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Brief Summary:
The purpose of this study is to evaluate the efficacy, tolerability and safety of patients on long-acting Risperidone microshpheres injection. The major advantage of long-acting injection over oral medication is facilitation of compliance in medication taking. Non-compliance is very common among schizophrenic and is a frequent cause of relapse.

Condition or disease Intervention/treatment Phase
Schizophrenia, Catatonic Schizophrenia, Disorganized Schizophrenia, Paranoid Schizophrenia Psychotic Disorders Drug: Long-acting Risperidone microspheres injection Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Non-Randomized
Primary Purpose: Treatment
Official Title: Evaluation of Efficacy and Safety of Long-acting Risperidone Microspheres in Patients With Schizophrenia or Other Psychotic Disorders When Switching From Typical Antipsychotic (Oral/Depot) or Atypical Oral Other Than Risperidone
Study Start Date : October 2004
Estimated Study Completion Date : November 2005

Resource links provided by the National Library of Medicine

Drug Information available for: Risperidone

Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. Efficacy/ Clinical Global Impression [ Time Frame: Week 0, 4, 8,12 ]
  2. Personal and Social Performance Scale [ Time Frame: Week 0, 12 ]
  3. Extrapyramidal Symptom [ Time Frame: Week 0, 4, 8,12 ]

Secondary Outcome Measures :
  1. +Quality of life SF-36 [ Time Frame: Week 0,12 ]
  2. Pain assoicated with injection VAS [ Time Frame: Week 0, 4, 8, 12 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Criteria

Inclusion Criteria:

  • Subjects with schizophrenia or another psychotic disorder according to DSM IV criteria who requires long term antipsychotic therapy
  • Currently treated with either an atypical antipsychotic, other than risperidone, a conventional depot antipsychotic or oral conventional antipsychotic
  • Subject has been symptomatically stable on a stable dose of an antipsychotic the last month
  • Subject and/or patient's relative, guardian or legal representative has signed the informed consent form

Exclusion Criteria:

  • First antipsychotic treatment ever
  • On clozapine during the last 3 month
  • Serious unstable medical condition
  • History or current symptoms of tardive dyskinesia
  • History of neuroleptic malignant syndrome
  • Pregnant or breast-feeding female
  • Female patient of childbearing potential without adequate contraception.
  • Participation in an investigational drug trial in the 30 days prior to selection
  • Known intolerance/non-responder to risperidone
Contacts and Locations
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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): NCT00563017


Contacts
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Contact: Wing King Lee, Dr (852) 2388 8559 ext 269 drwklee@gmail.com

Locations
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China
Kwai Chung Hospital Recruiting
Hong Kong, China
Sub-Investigator: Gloria FY Chan, Dr         
Sub-Investigator: Ming-ming Chan, Dr         
Sub-Investigator: Vincent WH Chan, Dr         
Sub-Investigator: Tin-sung Tam, Dr         
Sponsors and Collaborators
Hospital Authority, Hong Kong
Janssen Pharmaceutica N.V., Belgium
Investigators
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Principal Investigator: Wing King Lee, Dr Yaumatei Psychiatric Center, Kwai Chung Hospital
More Information
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Additional Information:

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ClinicalTrials.gov Identifier: NCT00563017    
Other Study ID Numbers: KW / EX / 04 - 038
HARECCTR0500047
First Posted: November 26, 2007    Key Record Dates
Last Update Posted: July 7, 2010
Last Verified: July 2010
Keywords provided by Hospital Authority, Hong Kong:
Catatonic Schizophrenia
Disorganized Schizophrenia
Paranoid Schizophrenia
Undifferentiated Schizophrenia
Schizo-affective disorders
Additional relevant MeSH terms:
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Catatonia
Disease
Schizophrenia
Mental Disorders
Psychotic Disorders
Schizophrenia, Paranoid
Schizophrenia, Disorganized
Schizophrenia, Catatonic
Pathologic Processes
Schizophrenia Spectrum and Other Psychotic Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
 Behavioral Symptoms
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