Status:
TERMINATED
An Observational Study to Evaluate Efficacy and Safety of Risperidone Long-Acting Injection for Treatment of Schizophrenia
Lead Sponsor:
Xian-Janssen Pharmaceutical Ltd.
Conditions:
Schizophrenia
Eligibility:
All Genders
18-65 years
Brief 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 emo...
Detailed Description
This is an open-label (all people know the identity of the intervention), multi-center (conducted in more than one center), prospective (study following participants forward in time) and observational...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2007
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
640 Patients enrolled
Trial Details
Trial ID
NCT01894984
Start Date
January 1 2007
End Date
December 1 2009
Last Update
May 8 2014
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