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 because the information has not been verified recently.
Verified July 2010 by Hospital Authority, Hong Kong.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Janssen Pharmaceutica N.V., Belgium
Information provided by:
Hospital Authority, Hong Kong
ClinicalTrials.gov Identifier:
NCT00563017
First received: November 21, 2007
Last updated: July 6, 2010
Last verified: July 2010
  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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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:
No publications provided

ClinicalTrials.gov Identifier: NCT00563017     History of Changes
Other Study ID Numbers: KW / EX / 04 - 038, HARECCTR0500047
Study First Received: November 21, 2007
Last Updated: July 6, 2010
Health Authority: Hong Kong: Ethics Committee

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

Additional relevant MeSH terms:
Disease
Mental Disorders
Psychotic Disorders
Schizophrenia
Schizophrenia, Catatonic
Schizophrenia, Disorganized
Schizophrenia, Paranoid
Pathologic Processes
Schizophrenia and Disorders with Psychotic Features
Antipsychotic Agents
Risperidone
Central Nervous System Agents
Central Nervous System Depressants
Dopamine Agents
Dopamine Antagonists
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Agents
Serotonin Antagonists
Therapeutic Uses
Tranquilizing Agents

ClinicalTrials.gov processed this record on October 29, 2014