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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

Primary Purpose

Schizophrenia, Catatonic, Schizophrenia, Disorganized, Schizophrenia, Paranoid

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Long-acting Risperidone microspheres injection
Sponsored by
Hospital Authority, Hong Kong
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia, Catatonic focused on measuring Catatonic Schizophrenia, Disorganized Schizophrenia, Paranoid Schizophrenia, Undifferentiated Schizophrenia, Schizo-affective disorders

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All Sexes

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

Sites / Locations

  • Kwai Chung HospitalRecruiting

Outcomes

Primary Outcome Measures

Efficacy/ Clinical Global Impression
Personal and Social Performance Scale
Extrapyramidal Symptom

Secondary Outcome Measures

+Quality of life SF-36
Pain assoicated with injection VAS

Full Information

First Posted
November 21, 2007
Last Updated
July 6, 2010
Sponsor
Hospital Authority, Hong Kong
Collaborators
Janssen Pharmaceutica N.V., Belgium
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1. Study Identification

Unique Protocol Identification Number
NCT00563017
Brief 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
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 Type
Interventional

2. Study Status

Record Verification Date
July 2010
Overall Recruitment Status
Unknown status
Study Start Date
October 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
November 2005 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Hospital Authority, Hong Kong
Collaborators
Janssen Pharmaceutica N.V., Belgium

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Catatonic, Schizophrenia, Disorganized, Schizophrenia, Paranoid, Schizophrenia, Psychotic Disorders
Keywords
Catatonic Schizophrenia, Disorganized Schizophrenia, Paranoid Schizophrenia, Undifferentiated Schizophrenia, Schizo-affective disorders

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Allocation
Non-Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Long-acting Risperidone microspheres injection
Primary Outcome Measure Information:
Title
Efficacy/ Clinical Global Impression
Time Frame
Week 0, 4, 8,12
Title
Personal and Social Performance Scale
Time Frame
Week 0, 12
Title
Extrapyramidal Symptom
Time Frame
Week 0, 4, 8,12
Secondary Outcome Measure Information:
Title
+Quality of life SF-36
Time Frame
Week 0,12
Title
Pain assoicated with injection VAS
Time Frame
Week 0, 4, 8, 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wing King Lee, Dr
Phone
(852) 2388 8559
Ext
269
Email
drwklee@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wing King Lee, Dr
Organizational Affiliation
Yaumatei Psychiatric Center, Kwai Chung Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kwai Chung Hospital
City
Hong Kong
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gloria FY Chan, Dr
First Name & Middle Initial & Last Name & Degree
Ming-ming Chan, Dr
First Name & Middle Initial & Last Name & Degree
Vincent WH Chan, Dr
First Name & Middle Initial & Last Name & Degree
Tin-sung Tam, Dr

12. IPD Sharing Statement

Learn more about this trial

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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