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

This study is currently recruiting participants.

Verified by Hospital Authority, Hong Kong, June 2008

First Received: November 21, 2007 Last Updated: June 23, 2009 History of Changes

Sponsors and Collaborators:	Hospital Authority, Hong Kong Janssen Pharmaceutica N.V., Belgium
Information provided by:	Hospital Authority, Hong Kong
ClinicalTrials.gov Identifier:	NCT00563017

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:	Treatment, Non-Randomized
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:

MedlinePlus related topics: Psychotic Disorders Schizophrenia

Drug Information available for: Risperidone

U.S. FDA Resources

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

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:

HAREC Clinical Trial Registry This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	KW / EX / 04 - 038, HARECCTR0500047
Study First Received:	November 21, 2007
Last Updated:	June 23, 2009
ClinicalTrials.gov Identifier:	NCT00563017 History of Changes
Health Authority:	Hong Kong: Ethics Committee

Keywords provided by Hospital Authority, Hong Kong:

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

Study placed in the following topic categories:

Neurotransmitter Agents
Schizophrenia, Disorganized
Tranquilizing Agents
Schizophrenia, Catatonic
Psychotropic Drugs
Risperidone
Central Nervous System Depressants
Antipsychotic Agents
Serotonin
Behavioral Symptoms
Schizophrenia

Signs and Symptoms
Schizophrenia, Paranoid
Dopamine
Mental Disorders
Mood Disorders
Neurologic Manifestations
Dopamine Agents
Psychotic Disorders
Neurobehavioral Manifestations
Catatonia
Schizophrenia and Disorders with Psychotic Features

Additional relevant MeSH terms:

Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Psychotropic Drugs
Schizophrenia
Signs and Symptoms
Schizophrenia, Paranoid
Serotonin Antagonists
Pathologic Processes
Mental Disorders
Therapeutic Uses
Psychotic Disorders
Neurobehavioral Manifestations
Catatonia
Schizophrenia and Disorders with Psychotic Features

Schizophrenia, Disorganized
Disease
Tranquilizing Agents
Schizophrenia, Catatonic
Nervous System Diseases
Risperidone
Central Nervous System Depressants
Dopamine Antagonists
Antipsychotic Agents
Pharmacologic Actions
Behavioral Symptoms
Serotonin Agents
Neurologic Manifestations
Dopamine Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on September 10, 2009