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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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00563017
Enrollment
30
Registered
2007-11-26
Start date
2004-10-31
Completion date
2005-11-30
Last updated
2010-07-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

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

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.

Interventions

DRUGLong-acting Risperidone microspheres injection

Sponsors

Janssen Pharmaceutica N.V., Belgium
CollaboratorINDUSTRY
Hospital Authority, Hong Kong
Lead SponsorOTHER_GOV

Study design

Allocation
NON_RANDOMIZED
Primary purpose
TREATMENT

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

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

Design outcomes

Primary

MeasureTime frame
Extrapyramidal SymptomWeek 0, 4, 8,12
Efficacy/ Clinical Global ImpressionWeek 0, 4, 8,12
Personal and Social Performance ScaleWeek 0, 12

Secondary

MeasureTime frame
+Quality of life SF-36Week 0,12
Pain assoicated with injection VASWeek 0, 4, 8, 12

Countries

China

Contacts

Primary ContactWing King Lee, Dr
drwklee@gmail.com(852) 2388 8559

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026