Trial | NCT00563017  Report issue

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

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Unknown status

  • Intervention/Treatment

    risperidone ...

  • Study Participants

    30
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.
Study Started
Oct 31
2004
Study Completion
Nov 30
2005
Anticipated
Last Update
Jul 07
2010
Estimate

Drug Long-acting Risperidone microspheres injection

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
No Results Posted