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

NCT00563017 | Unknown

• 2 other identifiers: KW / EX / 04 - 038HARECCTR0500047
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Schizophrenia, Catatonic; Schizophrenia, Disorganized; Schizophrenia, Paranoid; Schizophrenia; Psychotic Disorders

Keywords

Catatonic Schizophrenia; Disorganized Schizophrenia; Paranoid Schizophrenia; Undifferentiated Schizophrenia; Schizo-affective disorders

Outcome Measures

Primary Outcomes (3)

• Efficacy/ Clinical Global Impression

  Week 0, 4, 8,12

• Personal and Social Performance Scale

  Week 0, 12

• Extrapyramidal Symptom

  Week 0, 4, 8,12

Secondary Outcomes (2)

• +Quality of life SF-36

  Week 0,12

• Pain assoicated with injection VAS

  Week 0, 4, 8, 12

Interventions

Long-acting Risperidone microspheres injection DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital Authority, Hong Kong: lead
• Janssen Pharmaceutica N.V., Belgium: collaborator

Study Sites (1)

Kwai Chung Hospital

Hong Kong, China

RECRUITING

MeSH Terms

Conditions

Schizophrenia, Catatonic; Schizophrenia, Disorganized; Schizophrenia, Paranoid; Schizophrenia; Psychotic Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Officials

• Wing King Lee, Dr

  Yaumatei Psychiatric Center, Kwai Chung Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wing King Lee, Dr

CONTACT

(852) 2388 8559; drwklee@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Purpose: TREATMENT
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: November 21, 2007
• First Posted: November 26, 2007
• Study Start: October 1, 2004
• Study Completion: November 1, 2005
• Last Updated: July 7, 2010

Record last verified: 2010-07

Locations

CN (1)