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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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2010 by Hospital Authority, Hong Kong.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00563017
First Posted: November 26, 2007
Last Update Posted: July 7, 2010
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.
Collaborator:
Janssen Pharmaceutica N.V., Belgium
Information provided by:
Hospital Authority, Hong Kong
November 21, 2007
November 26, 2007
July 7, 2010
October 2004
Not Provided
  • Efficacy/ Clinical Global Impression [ Time Frame: Week 0, 4, 8,12 ]
  • Personal and Social Performance Scale [ Time Frame: Week 0, 12 ]
  • Extrapyramidal Symptom [ Time Frame: Week 0, 4, 8,12 ]
Same as current
Complete list of historical versions of study NCT00563017 on ClinicalTrials.gov Archive Site
  • +Quality of life SF-36 [ Time Frame: Week 0,12 ]
  • Pain assoicated with injection VAS [ Time Frame: Week 0, 4, 8, 12 ]
Same as current
Not Provided
Not Provided
 
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
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
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.
Not Provided
Interventional
Not Provided
Allocation: Non-Randomized
Primary Purpose: Treatment
  • Schizophrenia, Catatonic
  • Schizophrenia, Disorganized
  • Schizophrenia, Paranoid
  • Schizophrenia
  • Psychotic Disorders
Drug: Long-acting Risperidone microspheres injection
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
30
November 2005
Not Provided

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Not Provided
Contact information is only displayed when the study is recruiting subjects
China
 
 
NCT00563017
KW / EX / 04 - 038
HARECCTR0500047
Not Provided
Not Provided
Not Provided
Not Provided
Hospital Authority, Hong Kong
Janssen Pharmaceutica N.V., Belgium
Principal Investigator: Wing King Lee, Dr Yaumatei Psychiatric Center, Kwai Chung Hospital
Hospital Authority, Hong Kong
July 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP