An Observational Study to Evaluate Efficacy and Safety of Risperidone Long-Acting Injection for Treatment of Schizophrenia

• Status: Terminated
• Trial end date: 2009-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the long-term treatment efficacy, and safety of risperidone long-acting injection in participants with schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self).

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Xian-Janssen Pharmaceutical Ltd.
• Treatments: Antipsychotic Agents; Risperidone; Serotonin Uptake Inhibitors

Criteria

Inclusion Criteria:

• Male or female, age 18-65 years

• Participant must meet the diagnostic criteria for schizophrenia or schizophreniform disorder according to Diagnostic and Statistical Manual of Mental Disorders, fourth edition (DSM-IV)-TM

• Total course of disease no more than 5 years

• According to physician's discretion, participants need to be changed to risperidone long-acting injection and other atypical anti-psychotic drug

• Participant or their legally acceptable representatives must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study

Exclusion Criteria:

• Significant risk of suicidal or violent behavior, as clinically assessed by the Investigator

• Have aggressive behavior and excited , restless

• History or current symptoms of tardive dyskinesia; neuroleptic malignant syndrome; evidence of dysfunction of liver and kidney and other severe physical diseases; and severe, life-threatening allergic reaction to any drug

• Known hypersensitivity to risperidone

• Female participant who is pregnant or breastfeeding or planning to become pregnant during the study period