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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
Janssen Pharmaceutica N.V., Belgium
Information provided by:
Hospital Authority, Hong Kong Identifier:
First received: November 21, 2007
Last updated: July 6, 2010
Last verified: July 2010
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
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

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All

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
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Please refer to this study by its identifier: NCT00563017

Contact: Wing King Lee, Dr (852) 2388 8559 ext 269

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

Additional Information: Identifier: NCT00563017     History of Changes
Other Study ID Numbers: KW / EX / 04 - 038
Study First Received: November 21, 2007
Last Updated: July 6, 2010

Keywords provided by Hospital Authority, Hong Kong:
Catatonic Schizophrenia
Disorganized Schizophrenia
Paranoid Schizophrenia
Undifferentiated Schizophrenia
Schizo-affective disorders

Additional relevant MeSH terms:
Mental Disorders
Psychotic Disorders
Schizophrenia, Catatonic
Schizophrenia, Paranoid
Schizophrenia, Disorganized
Pathologic Processes
Schizophrenia Spectrum and Other Psychotic Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Behavioral Symptoms
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Dopamine Antagonists
Dopamine Agents processed this record on May 25, 2017