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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
  Purpose
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 Intervention
Schizophrenia, Catatonic Schizophrenia, Disorganized Schizophrenia, Paranoid Schizophrenia Psychotic Disorders Drug: Long-acting Risperidone microspheres injection

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Hospital Authority, Hong Kong:

Primary Outcome Measures:
  • 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 ]

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

Estimated Enrollment: 30
Study Start Date: October 2004
Estimated Study Completion Date: November 2005
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
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
Contact: Wing King Lee, Dr (852) 2388 8559 ext 269 drwklee@gmail.com

Locations
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
Principal Investigator: Wing King Lee, Dr Yaumatei Psychiatric Center, Kwai Chung Hospital
  More Information

Additional Information:
ClinicalTrials.gov Identifier: NCT00563017     History of Changes
Other Study ID Numbers: KW / EX / 04 - 038
HARECCTR0500047
First Submitted: November 21, 2007
First Posted: November 26, 2007
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:
Disease
Schizophrenia
Mental Disorders
Psychotic Disorders
Catatonia
Schizophrenia, Paranoid
Schizophrenia, Disorganized
Schizophrenia, Catatonic
Pathologic Processes
Schizophrenia Spectrum and Other Psychotic Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Behavioral Symptoms
Risperidone
Antipsychotic Agents
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents